Frederick Feit, M.D.

Incidence and clinical consequences of acquired thrombocytopenia after antithrombotic therapies in patients with acute coronary syndromes: results from the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial
Caixeta, Adriano; Dangas, George D; Mehran, Roxana; Feit, Frederick; Nikolsky, Eugenia; Lansky, Alexandra J; Aoki, Jiro; Moses, Jeffrey W; Steinhubl, Steven R; White, Harvey D; Ohman, E Magnus; Manoukian, Steven V; Fahy, Martin; Stone, Gregg W
2011 Feb;161(2):298-306.e1, American heart journal
BACKGROUND: The aim of the study was to investigate the incidence and clinical consequences of acquired thrombocytopenia in patients with acute coronary syndromes (ACS) in the ACUITY trial. METHODS: We examined 10,836 patients with ACS randomized to receive heparin plus glycoprotein (GP) IIb/IIIa inhibitor, bivalirudin plus GP IIb/IIIa inhibitor, or bivalirudin monotherapy. RESULTS: Acquired thrombocytopenia developed in 740 (6.8%) patients; mild (100,000-150,000 platelets/mm(3)), moderate (50,000-100,000 platelets/mm(3)), and severe (< 50,000 platelets/mm(3)) developed in 656 (6%), 51 (0.5%), and 33 (0.3%) patients, respectively. Patients with acquired thrombocytopenia, compared with those without, were more likely to develop major bleeding (14% vs 4.3%, P < .0001) at 30 days and had higher rates of mortality (6.5% vs 3.4%, P < .0001) at 1 year. By multivariate analysis, acquired thrombocytopenia was an independent predictor of major bleeding at 30 days (hazard ratio [HR] 1.68, 95% CI 1.04-2.72, P = .03). Moderate and severe acquired thrombocytopenia were predictors of mortality at 1 year (HR 2.89, 95% CI 0.92-9.06, P = .06, and HR 3.41, 95% CI 1.09-10.68, P = .03, respectively). Compared to heparin plus GP IIb/IIIa inhibitor, bivalirudin monotherapy was associated with less declines in platelet count by >25% (7.6% vs 5.6%, P = .0009) and >50% (1.4% vs 0.7%, P = .004) from baseline. CONCLUSIONS: Acquired thrombocytopenia occurs in approximately 1 in 14 patients with ACS treated with antithrombin and antiplatelet medications and is strongly associated with hemorrhagic and ischemic complications. Compared to an anticoagulant regimen including a GP IIb/IIIa inhibitor, administration of bivalirudin monotherapy appears to be associated with less frequent declines in platelet count
— id: 134112, year: 2011, vol: 161, page: 298, stat: Journal Article,

Impact of bivalirudin therapy on mortality in patients with high risk features undergoing PCI: A patient-level pooled analysis from the REPLACE-2, ACUITY and HORIZONS-AMI trials
Dangas G.; Mehran R.; Feit F.; Cox D.; Brodie B.R.; Witzenbichler B.; Deliargyris E.; Gersh B.; Stone G.W.
2011 ;32:232-233, European heart journal
Purpose: Compared to Heparin + GP IIb/IIIa inhibitors (GPI), bivalirudin has been shown to decrease bleeding complications in several clinical presentations ncluding: percutaneous coronary intervention (PCI) in stable ischemic syndromes, unstable angina, NSTEMI and STEMI (REPLACE-2, ACUITY and HORIZONS rials). A survival benefit was observed in STEMI patients, but not in other scenarios. We investigated the impact of bivalirudin on survival in pts enrolled in hese trials according to high risk clinical features (reduced LVEF, advanced age, diabetes mellitus (DM), anemia, chronic kidney disease (CKD), clinical resentation, and prior MI). Methods: We examined patient-based pooled data of 3 randomized trials, identified 14,258 pts who received dual anti-platelet herapy undergoing PCI, and constructed a risk adjusted mortality model using the following variables: age >65, presence of DM, hypertension, CrCl lt;60mg/mL, LVEF <35%, NSTEMI, STEMI, previous MI and hematocrit <36%. Cox regression methods were used for statistical analysis. Results: The relative isks of 1-year mortality favored bivalirudin over heparin + GPI and were concordant in the presence of each individual high risk feature (Figure presented) xamined; the lowest relative risk was associated with LVEF <35% (0.47, 0.30- 0.72, p=0.0004) (Figure 1, right). The presence of 3 or more risk factors (n=6176; 43.3% of all pts) was also associated with lower 1-month and 1-year mortality with bivalirudin therapy compared to GPI (Figure 1, left). All above results were consistent in all three trials. Conclusions: Treatment with bivalirudin may improve survival in patients with high risk features and ACS and/or undergoing PCI. he largest benefit was present in patients with moderate/severe LV dysfunction. Further studies are required to confirm these results
— id: 137912, year: 2011, vol: 32, page: 232, stat: Journal Article,

Prognostic Significance of Coronary Thrombus in Patients Undergoing Percutaneous Coronary Intervention for Acute Coronary Syndromes A Subanalysis of the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) Trial
Goto, Kenji; Lansky, Alexandra J; Nikolsky, Eugenia; Fahy, Martin; Feit, Frederick; Ohman, E Magnus; White, Harvey D; Mehran, Roxana; Bertrand, Michel E; Desmet, Walter; Hamon, Martial; Stone, Gregg W
2011 Jul;4(7):769-777, JACC: Cardiovascular Interventions
OBJECTIVES: The objective of this study is to investigate the incidence and clinical implications of thrombus on baseline angiography among patients presenting with non-ST-segment elevation acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI). BACKGROUND: Given current advances in the pharmacological and mechanical treatment of ACS patients managed with an early invasive strategy, the incidence and prognostic importance of pre-procedural lesion thrombus is warranted. METHODS: In the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial, a total of 3,627 patients with moderate- and high-risk ACS undergoing PCI had their baseline and final post-PCI angiograms analyzed by an independent angiographic core laboratory. RESULTS: Patients with thrombus (n = 530 [15%]) compared with those without thrombus had higher rates of impaired final epicardial coronary flow (final Thrombolysis In Myocardial Infarction [TIMI] flow grade 3: 89.6% vs. 97.1%, p < 0.0001). Thrombus was an independent predictor of 30 day death (odds ratio [OR]: 3.16 [95% confidence interval (CI): 1.20 to 8.37], p = 0.02), and myocardial infarction (MI) at 30 days (OR: 1.62 [95% CI: 1.17 to 2.24], p = 0.003) and at 1 year (OR: 1.56 [95% CI: 1.16 to 2.08], p = 0.003). Patients with thrombus had significantly higher rates of stent thrombosis (ST) compared with patients without thrombus at 30 days (2.8% vs. 1.1%, p = 0.002) and at 1 year (3.7% vs. 1.8%, p = 0.003), and thrombus was an independent predictor of ST at both 30 days (OR: 2.61 [95% CI: 1.38 to 4.91]) and 1 year (OR: 2.98 [95% CI: 1.64 to 5.42]). CONCLUSIONS: Pre-procedural thrombus was present in 15% of moderate- and high-risk ACS patients undergoing PCI in the ACUITY trial. Baseline thrombus predicts increased ischemic complications at 30 days including a 3-fold increased risk of death as well as MI up to 1 year. Further evaluation of adjunctive pharmacotherapy is needed in this high-risk population
— id: 136496, year: 2011, vol: 4, page: 769, stat: Journal Article,

Response to letters regarding article, "Predictors of outcomes in medically treated patients with acute coronary syndromes after angiographic triage: an Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) substudy"
Lansky, Alexandra; Goto, Kenji; Fahy, Martin; Cristea, Ecatarina; Mehran, Roxana; Stone, Gregg W; Feit, Frederick; Ohman, E Magnus; Alexander, Karen P; White, Harvey D; Bertrand, Michel E; Desmet, Walter; Hamon, Martial
2011 Apr 19;123(15):e410-e411, Circulation
— id: 134247, year: 2011, vol: 123, page: e410, stat: Journal Article,

Impact of Bleeding on Mortality After Percutaneous Coronary Intervention Results From a Patient-Level Pooled Analysis of the REPLACE-2 (Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events), ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy), and HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) Trials
Mehran, Roxana; Pocock, Stuart; Nikolsky, Eugenia; Dangas, George D; Clayton, Tim; Claessen, Bimmer E; Caixeta, Adriano; Feit, Frederick; Manoukian, Steven V; White, Harvey; Bertrand, Michel; Ohman, E Magnus; Parise, Helen; Lansky, Alexandra J; Lincoff, A Michael; Stone, Gregg W
2011 Jun;4(6):654-664, JACC: Cardiovascular Interventions
OBJECTIVES: This study sought to develop a risk score predictive of bleeding in patients undergoing percutaneous coronary intervention (PCI) and to investigate the impact of bleeding on subsequent mortality. BACKGROUND: Bleeding complications after PCI have been independently associated with early and late mortality. METHODS: This study represents a patient-level pooled analysis including 17,034 patients undergoing PCI from 3 large, randomized trials of bivalirudin versus heparin plus glycoprotein IIb/IIIa inhibitors, including the REPLACE-2 (Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events), ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy), and HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trials. We developed a risk score to predict noncoronary artery bypass graft (CABG)-related TIMI (Thrombolysis In Myocardial Infarction) major bleeding and evaluated the impact of various types of bleeding on 1-year mortality. RESULTS: A non-CABG-related TIMI major bleed occurred within 30 days in 267 patients (1.6%), and death occurred in 497 patients (2.9%) within 1 year. A risk score was developed to predict the bleeding risk of patients undergoing PCI, consisting of 7 variables (serum creatinine, age, sex, presentation, white blood cell count, cigarette smoking, and randomized treatment). The TIMI major bleeding rates increased by bleeding risk score groups: from 0.4% for those in the lowest to 5.8% for those in the highest risk group. Non-CABG-related TIMI major bleeding and the occurrence of myocardial infarction within 30 days were independent predictors of subsequent mortality, with respective hazard ratios of 4.2 and 2.9, each p < 0.001. Ranked in order of severity, TIMI major bleeding, blood transfusion without TIMI bleed, TIMI minor bleeding requiring blood transfusion, and TIMI minor bleeding not requiring blood transfusion were independent predictors of subsequent mortality with hazard ratios of 4.89, 2.91, 2.73, and 1.66, respectively. Isolated hematomas were not predictive of subsequent mortality. CONCLUSIONS: Non-CABG-related bleeding within 30 days is strongly associated with an increased risk of subsequent mortality at 1 year in patients undergoing PCI for all indications. A risk score was established to calculate the bleeding risk for patients undergoing PCI, allowing therapeutic decision making to minimize the incidence of bleeding
— id: 136477, year: 2011, vol: 4, page: 654, stat: Journal Article,

Mechanisms of Myocardial Infarction in Women Without Angiographically Obstructive Coronary Artery Disease
Reynolds HR; Srichai MB; Iqbal SN; Slater JN; Mancini GB; Feit F; Pena-Sing I; Axel L; Attubato MJ; Yatskar L; Kalhorn RT; Wood DA; Lobach IV; Hochman JS
2011 Sep 27;124(13):1414-1425, Circulation
BACKGROUND: . Unique identifier: NCT00798122
— id: 137093, year: 2011, vol: 124, page: 1414, stat: Journal Article,

Sex and race are associated with the absence of epicardial coronary artery obstructive disease at angiography in patients with acute coronary syndromes
Chokshi, Neel P; Iqbal, Sohah N; Berger, Rachel L; Hochman, Judith S; Feit, Frederick; Slater, James N; Pena-Sing, Ivan; Yatskar, Leonid; Keller, Norma M; Babaev, Anvar; Attubato, Michael J; Reynolds, Harmony R
2010 Aug;33(8):495-501, Clinical cardiology
BACKGROUND: A substantial minority of patients with acute coronary syndromes (ACS) do not have a diameter stenosis of any major epicardial coronary artery on angiography ('no obstruction at angiography') of >/= 50%. We examined the frequency of this finding and its relationship to race and sex. HYPOTHESIS: Among patients with myocardial infarction, younger age, female sex and non-white race are associated with the absence of obstructive coronary artery disease at angiography. METHODS: We reviewed the results of all angiograms performed from May 19, 2006 to September 29, 2006 at 1 private (n = 793) and 1 public (n = 578) urban academic medical center. Charts were reviewed for indication and results of angiography, and for demographics. RESULTS: The cohort included 518 patients with ACS. There was no obstruction at angiography in 106 patients (21%), including 48 (18%) of 258 patients with myocardial infarction. Women were more likely to have no obstruction at angiography than men, both in the overall cohort (55/170 women [32%] vs 51/348 men [15%], P < 0.001) and in the subset with MI (29/90 women [32%] vs 19/168 men [11%], P < 0.001). Black patients were more likely to have no obstruction at angiography relative to any other subgroup (24/66 [36%] vs 41/229 [18%] Whites, 31/150 [21%] Hispanics, and 5/58 [9%] Asians, P = 0.001). Among women, Black patients more frequently had no obstruction at angiography compared with other ethnic groups (16/27 [59%] vs 17/59 [29%] Whites, 17/60 [28%] Hispanics, and 3/19 [6%] Asians, P = 0.001). CONCLUSIONS: A high proportion of a multiethnic sample of patients with ACS were found to have no stenosis >/= 50% in diameter at coronary angiography. This was particularly common among women and Black patients.
— id: 111980, year: 2010, vol: 33, page: 495, stat: Journal Article,

Mechanisms of Thrombosis Induction and Mitigation with Contrast Media: Comparative Effects and Implications for Percutaneous Coronary Intervention
Fisch, Mark; Feit, Frederick
2010 MAR ;22(12):4A-9A, Journal of invasive cardiology
Four broad classes of iodinated contrast media (CM) are utilized in coronary angiography: ionic monomers, the ionic dimer, ioxaglate (Hexabrix, Guerbet LLC, Bloomington, Indiana), nonionic monomers and the nonionic dimer, iodixanol (Visipaque, GE Healthcare Inc., Princeton, New Jersey). Data from in-vitro studies and experimental animal models demonstrate profound differences in pro- and antithrombotic properties of the different classes of CM with the ionic dimer, ioxaglate, having the most favorable antithrombotic properties. Early clinical data suggest that these in-vitro observations may translate into a reduction in the incidence of intracoronary thrombus formation during percutaneous coronary intervention (PCI)
— id: 115368, year: 2010, vol: 22, page: 4A, stat: Journal Article,

Predictors of outcomes in medically treated patients with acute coronary syndromes after angiographic triage: an Acute Catheterization And Urgent Intervention Triage Strategy (ACUITY) substudy
Goto, Kenji; Lansky, Alexandra J; Fahy, Martin; Cristea, Ecatarina; Feit, Frederick; Ohman, E Magnus; White, Harvey D; Alexander, Karen P; Bertrand, Michel E; Desmet, Walter; Hamon, Martial; Mehran, Roxana; Stone, Gregg W
2010 Feb 23;121(7):853-862, Circulation
BACKGROUND: Outcomes of patients presenting with acute coronary syndromes are improved with an early invasive approach; however, approximately one third of these patients are treated medically after angiographic screening. We sought to assess the predictors of adverse cardiac events in patients with acute coronary syndrome assigned to medical management. METHODS AND RESULTS: This substudy of the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial included 4491 acute coronary syndrome patients treated medically after angiographic triage. Rates of bleeding and composite ischemia (death, myocardial infarction, revascularization) were compared among the 3 antithrombotic treatment arms. Composite ischemia occurred in 399 patients (9.5%) at 1 year. Treatment with bivalirudin glycoprotein IIb/IIIa inhibitors significantly reduced major bleeding at 30 days (2.5% bivalirudin monotherapy; P=0.005, 2.0% bivalirudin plus glycoprotein IIb/IIIa inhibitors; P=0.0002 versus 4.4% heparin with glycoprotein IIb/IIIa inhibitors). Composite ischemic events at 1 year were not significantly different in the 3 groups (bivalirudin monotherapy, 9.6%; bivalirudin plus glycoprotein IIb/IIIa inhibitors, 9.7%; heparin plus glycoprotein IIb/IIIa inhibitors, 9.1%). Independent predictors of composite ischemia were mostly angiographic factors at 30 days, including jeopardy score and coronary ectasia, and at 1 year, including previous percutaneous coronary intervention, jeopardy score, coronary ectasia, and increasing number of diseased vessels. CONCLUSIONS: Among the ACUITY acute coronary syndrome patients treated medically after angiographic triage, bivalirudin therapy significantly reduced bleeding complications compared with heparin without any negative impact on ischemic outcomes at 1 year. The most powerful predictors of ischemic outcomes were angiographic rather than traditional clinical parameters, supporting the early use of angiographic screening in the moderate- and high-risk but medically treated acute coronary syndrome population. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00093158
— id: 147276, year: 2010, vol: 121, page: 853, stat: Journal Article,

Comparison of catheterization laboratory initiated abciximab and eptifibatide during percutaneous coronary intervention in acute coronary syndromes (an ACUITY substudy)
Kirtane, Ajay J; Parise, Helen; Mehran, Roxana; Moses, Jeffrey W; Fahy, Martin; Bertrand, Michel E; Ohman, E Magnus; White, Harvey D; Feit, Frederick; Colombo, Antonio; McLaurin, Brent T; Cox, David A; Ware, James H; Pocock, Stuart J; Lansky, Alexandra J; Stone, Gregg W
2010 Jul 15;106(2):180-186, American journal of cardiology
Abciximab and eptifibatide have been shown to reduce ischemic complications compared with heparin alone in patients with acute coronary syndromes who undergo percutaneous coronary intervention. Whether 1 agent is safer and/or more effective has not been prospectively examined. The aim of this study was to assess the outcomes related to downstream glycoprotein IIb/IIIa inhibitor treatment selection during percutaneous coronary intervention in 2,211 patients with moderate and high-risk acute coronary syndromes in the prospective multicenter Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial. The protocol permitted operator selection of abciximab (n = 835) or eptifibatide (n = 1,376) for routine use in the trial. Multivariate and propensity-based adjustments were used to assess the independent association of glycoprotein IIb/IIIa inhibitor treatment selection with prespecified study end points. Compared to patients receiving eptifibatide, those administered abciximab were older, more likely to be enrolled outside of North America, more frequently had biomarker elevations and ST-segment deviation, but had fewer baseline cardiac risk factors and previous revascularization procedures. After multivariate propensity-based adjustment, abciximab was independently associated with significantly fewer net clinical adverse events (odds ratio 0.61, 95% confidence interval 0.42 to 0.90, p = 0.01), mediated by composite ischemia (odds ratio 0.61, 95% confidence interval 0.38 to 0.98, p = 0.04) and major bleeding (odds ratio 0.58, 95% confidence interval 0.34 to 1.00, p = 0.051). In conclusion, in this prespecified but nonrandomized comparison in patients with acute coronary syndromes who underwent percutaneous coronary intervention with catheterization laboratory initiation of glycoprotein IIb/IIIa inhibitors, the use of abciximab rather than eptifibatide was associated with improved clinical outcomes at 30 days. These findings should be viewed as exploratory in light of the nonrandomized and heterogeneous nature of the comparator groups and significant potential for residual confounding
— id: 147267, year: 2010, vol: 106, page: 180, stat: Journal Article,

Clinical and Angiographic Predictors of Short- and Long-Term Ischemic Events in Acute Coronary Syndromes: Results From the Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) Trial
Lansky, Alexandra J; Goto, Kenji; Cristea, Ecaterina; Fahy, Martin; Parise, Helen; Feit, Frederick; Ohman, E Magnus; White, Harvey D; Alexander, Karen P; Bertrand, Michel E; Desmet, Walter; Hamon, Martial; Mehran, Roxana; Moses, Jeffrey; Leon, Martin; Stone, Gregg W
2010 Aug 1;3(4):308-316, Circulation: Cardiovascular Interventions
Background- Contemporary adjunctive pharmacology and revascularization strategies have improved the prognosis of patients with acute coronary syndromes (ACSs). We sought to identify the clinical and angiographic predictors of cardiac ischemic events in patients with ACSs treated with an early invasive strategy. Methods and Results- Multivariable logistic regression was used to analyze the relation between baseline characteristics and 30-day and 1-year composite ischemia (death, myocardial infarction, or unplanned revascularization) among the 6921 ACS patients included in the prespecified angiographic substudy of the Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) trial. Of the 6921 patients, 3826 (55.3%) were treated with percutaneous coronary intervention, 755 (10.9%) with coronary artery bypass grafting, and 2340 (33.8%) with medical therapy. Composite ischemia occurred in 595 (8.6%) patients at 30 days and in 1153 (17.4%) at 1 year. Renal insufficiency, biomarker elevation, ST-segment deviation, nonuse of aspirin or thienopyridine, insulin-treated diabetes, older age, baseline lower hemoglobin value, history of percutaneous coronary intervention, and current smoking were independently associated with 30-day or 1-year ischemic events. Angiographic characteristics predicting ischemic events included number of diseased vessels, moderate/severe calcification, worst percent diameter stenosis, jeopardy score, lower left ventricular ejection fraction, lesion eccentricity, and thrombus. With use of receiver operating characteristic methodology, the c statistic improved for the predictive model by adding angiographic to clinical parameters for the 30-day composite ischemia (from 0.62 to 0.68) and myocardial infarction (from 0.64 to 0.71) and 1-year composite ischemia (from 0.61 to 0.65) and myocardial infarction (from 0.63 to 0.69) end points. Conclusions- Among ACS patients managed with an early invasive strategy, baseline angiographic markers of disease burden, calcification, lesion severity, lower left ventricular ejection fraction, and morphological characteristics provided important added independent predictive value for 30-day and 1-year ischemic outcomes, beyond the well-recognized clinical risk factors. These findings emphasize the prognostic importance of the diagnostic angiogram in the risk stratification of patients presenting with ACSs. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00093158
— id: 111820, year: 2010, vol: 3, page: 308, stat: Journal Article,

A risk score to predict bleeding in patients with acute coronary syndromes
Mehran, Roxana; Pocock, Stuart J; Nikolsky, Eugenia; Clayton, Tim; Dangas, George D; Kirtane, Ajay J; Parise, Helen; Fahy, Martin; Manoukian, Steven V; Feit, Frederick; Ohman, Magnus E; Witzenbichler, Bernard; Guagliumi, Giulio; Lansky, Alexandra J; Stone, Gregg W
2010 Jun 8;55(23):2556-2566, Journal of the American College of Cardiology
OBJECTIVES: The aim of this study was to develop a practical risk score to predict the risk and implications of major bleeding in acute coronary syndromes (ACS). BACKGROUND: Hemorrhagic complications have been strongly linked with subsequent mortality in patients with ACS. METHODS: A total of 17,421 patients with ACS (including non-ST-segment elevation myocardial infarction [MI], ST-segment elevation MI, and biomarker negative ACS) were studied in the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) and the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) trials. An integer risk score for major bleeding within 30 days was developed from a multivariable logistic regression model. RESULTS: Non-coronary artery bypass graft surgery (CABG)-related major bleeding within 30 days occurred in 744 patients (7.3%) and had 6 independent baseline predictors (female sex, advanced age, elevated serum creatinine and white blood cell count, anemia, non-ST-segment elevation MI, or ST-segment elevation MI) and 1 treatment-related variable (use of heparin + a glycoprotein IIb/IIIa inhibitor rather than bivalirudin alone) (model c-statistic = 0.74). The integer risk score differentiated patients with a 30-day rate of non-CABG-related major bleeding ranging from 1% to over 40%. In a time-updated covariate-adjusted Cox proportional hazards regression model, major bleeding was an independent predictor of a 3.2-fold increase in mortality. The link to mortality risk was strongest for non-CABG-related Thrombolysis In Myocardial Infarction (TIMI)-defined major bleeding followed by non-TIMI major bleeding with or without blood transfusions, whereas isolated large hematomas and CABG-related bleeding were not significantly associated with subsequent mortality. CONCLUSIONS: Patients with ACS have marked variation in their risk of major bleeding. A simple risk score based on 6 baseline measures plus anticoagulation regimen identifies patients at increased risk for non-CABG-related bleeding and subsequent 1-year mortality, for whom appropriate treatment strategies can be implemented
— id: 147269, year: 2010, vol: 55, page: 2556, stat: Journal Article,

Response to Letter Regarding Article, "Impact of Femoral Vascular Closure Devices and Antithrombotic Therapy on Access Site Bleeding in Acute Coronary Syndromes: The Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) Trial"
Sanborn, TA; Feit, F; Stone, GW
2010 JUN ;3(3):E13-E13, Circulation: Cardiovascular Interventions
— id: 111337, year: 2010, vol: 3, page: E13, stat: Journal Article,

Impact of femoral vascular closure devices and antithrombotic therapy on access site bleeding in acute coronary syndromes: The Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial
Sanborn, Timothy A; Ebrahimi, Ramin; Manoukian, Steven V; McLaurin, Brent T; Cox, David A; Feit, Frederick; Hamon, Martial; Mehran, Roxana; Stone, Gregg W
2010 Feb 1;3(1):57-62, Circulation: Cardiovascular Interventions
BACKGROUND: The Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial demonstrated that bivalirudin monotherapy significantly reduces major bleeding compared with heparin (unfractionated or enoxaparin) or bivalirudin plus a glycoprotein IIb/IIIa inhibitor in acute coronary syndromes. Whether vascular closure devices (VCD) impact these results is unknown. Therefore, this study sought to determine whether VCD impact major access site bleeding (ASB) in patients with acute coronary syndromes undergoing early invasive management by the femoral approach. METHODS AND RESULTS: Major ASB in ACUITY was defined as ASB requiring interventional or surgical correction, hematoma > or =5 cm at the access site, retroperitoneal bleeding, or hemoglobin drop > or =3 g/dL with ecchymosis or hematoma <5 cm, oozing blood, or prolonged bleeding (>30 minutes) at the access site. Stepwise logistical regression was performed to identify the independent determinants of ASB. Of 11 621 patients undergoing angiography with or without percutaneous coronary intervention by the femoral approach, 4307 (37.1%) received a VCD and 7314 (62.9%) did not. Rates of major ASB were lower with VCD compared with no VCD (2.5% versus 3.3%, relative risk, 0.76; 95% CI, 0.61 to 0.94; P=0.01) and were lowest in patients treated with bivalirudin monotherapy and a VCD (0.7%). Stepwise logistic regression revealed that a VCD (odds ratio, 0.78; 95% CI, 0.61 to 0.99; P=0.04) and bivalirudin monotherapy (odds ratio, 0.35; 95% CI, 0.25 to 0.49; P<0.0001) were both independent determinates of freedom from major ASB. CONCLUSIONS: In patients with acute coronary syndromes undergoing an early invasive management strategy by the femoral approach, the use of a VCD, bivalirudin monotherapy, or both minimizes rates of major ASB. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique Identifier: NCT00093158
— id: 133817, year: 2010, vol: 3, page: 57, stat: Journal Article,

Outcomes of Patients With Acute Coronary Syndromes and Chronic Renal Insufficiency: Prognostic Importance of Troponin Elevation and Role of Adjunctive Antithrombotic Therapy (Analysis From the Acuity Trial)
Acharji, S; Nikolsky, E; Mehran, R; Lansky, AJ; Dangas, GD; Feit, F; Manoukian, S; Kirtane, AJ; Caixeta, A; Kesanakurthy, V; Stone, GW
2009 NOV 3 ;120(18):S1126-S1126, Circulation
— id: 106984, year: 2009, vol: 120, page: S1126, stat: Journal Article,

Bleeding and Ischemic Complications in Patients With Acute Coronary Syndromes and Chronic Kidney Disease in Relation to Different Glycoprotein IIb/IIIa Inhibitors: Analysis From the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) Trial
Afolabi-Brown, O; Nikolsky, E; Lansky, AJ; Mehran, R; Fahy, M; McLaurin, BT; Cox, DA; Feit, F; Colombo, A; Caixeta, A; Stone, GW
2009 NOV 3 ;120(18):S1028-S1028, Circulation
— id: 106981, year: 2009, vol: 120, page: S1028, stat: Journal Article,

Impact of Different Glycoprotein IIb/IIIa Inhibitors in Patients with Acute Coronary Syndromes and Baseline Chronic Kidney Disease: Analysis From The ACUITY Trial
Afolabi-Brown, O; Nikolsky, E; Mehran, R; Lansky, AJ; Caixeta, A; Fahy, M; McLaurin, BT; Cox, DA; Feit, F; Colombo, A; Corral, M; Gower, MJ; Suryadevara, R; Stone, GW
2009 SEP 21 ;104(6A):173D-173D, American journal of cardiology
— id: 104886, year: 2009, vol: 104, page: 173D, stat: Journal Article,

Outcomes following pre-operative clopidogrel administration in patients with acute coronary syndromes undergoing coronary artery bypass surgery: the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial
Ebrahimi, Ramin; Dyke, Cornelius; Mehran, Roxana; Manoukian, Steven V; Feit, Frederick; Cox, David A; Gersh, Bernard J; Ohman, E Magnus; White, Harvey D; Moses, Jeffrey W; Ware, James H; Lincoff, A Michael; Stone, Gregg W
2009 May 26;53(21):1965-1972, Journal of the American College of Cardiology
OBJECTIVES: This study sought to evaluate the impact of upstream clopidogrel in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) requiring coronary artery bypass grafting (CABG) from the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial. BACKGROUND: Despite benefits of clopidogrel in patients with NSTE-ACS undergoing percutaneous coronary intervention, this agent is often not administered upstream (before angiography) as recommended by the American College of Cardiology/American Heart Association guidelines because of potential bleeding in the minority of patients who require CABG. METHODS: The ACUITY trial enrolled 13,819 patients with NSTE-ACS undergoing early invasive management. The timing of clopidogrel initiation was per investigator discretion. A 5-day washout period before CABG was recommended for patients having received clopidogrel. RESULTS: Of 13,819 patients enrolled, 1,539 (11.1%) underwent CABG before discharge. Clopidogrel-exposed patients had a longer median duration of hospitalization (12.0 days vs. 8.9 days, p < 0.0001), but fewer adverse composite ischemic events (death, myocardial infarction, or unplanned revascularization) at 30 days; 12.7% vs. 17.3%, p = 0.01), with nonsignificantly different rates of non-CABG-related major bleeding (3.4% vs. 3.2%, p = 0.87) and post-CABG major bleeding (50.3% vs. 50.9%, p = 0.83) compared with those patients not administered clopidogrel. By multivariable analysis, clopidogrel use before CABG was an independent predictor of reduced 30-day composite ischemia (odds ratio: 0.67, 95% confidence interval: 0.48 to 0.92, p = 0.001) but not of increased post-CABG major bleeding (odds ratio: 0.98, 95% confidence interval: 0.80 to 1.19, p = 0.80). CONCLUSIONS: Clopidogrel administration before catheterization in patients with NSTE-ACS requiring CABG is associated with significantly fewer 30-day adverse ischemic events without significantly increasing major bleeding, compared to withholding clopidogrel until after angiography. These findings support the American College of Cardiology/American Heart Association guidelines for upstream clopidogrel administration in all NSTE-ACS patients, including those who subsequently undergo CABG. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes [ACS]; NCT00093158)
— id: 133686, year: 2009, vol: 53, page: 1965, stat: Journal Article,

One-year Mortality in Patients with Diabetes Mellitus Undergoing P
Feit, F; Gurm, HS; Manoukian, SV; Lincoff, AM; Witzenbichler, B; Parise, H; White, HD; Mehran, R; Stone, GW
2009 SEP 21 ;104(6A):187D-187D, American journal of cardiology
— id: 104887, year: 2009, vol: 104, page: 187D, stat: Journal Article,

Outcomes of patients with diabetes mellitus undergoing PCI treated with bivalirudin versus heparin plus a glycoprotein IIb/IIIa inhibitor: Pooled analysis from the REPLACE-2, ACUITY and HORIZONS-AMI Trials
Feit, F; Gurm, HS; Witzenbichler, B; Parise, H; Lincoff, AM; Manoukian, SV; White, HD; Pocock, SJ; Mehran, R; Stone, GW
2009 MAR 10 ;53(10):A31-A31, Journal of the American College of Cardiology
— id: 97553, year: 2009, vol: 53, page: A31, stat: Journal Article,

Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting In Patients With Acute Coronary Syndromes And Proximal LAD Disease: Analysis From The Acuity Trial
Guo, N; Nikolsky, E; Lansky, AJ; Ben Gal, Y; Maehara, A; McLaurin, BT; Cox, DA; Moses, JW; Feit, F; Colombo, A; Mehran, R; Lasalle, L; Stone, GW
2009 SEP 21 ;104(6A):107D-107D, American journal of cardiology
— id: 104885, year: 2009, vol: 104, page: 107D, stat: Journal Article,

Clinical Outcomes of Percutaneous Coronary Intervention using Bivalirudin Versus Heparin plus Glycoprotein IIb/IIIa Inhibitors in the NHLBI Dynamic Registry
Iqbal, SN; Selzer, F; Feit, F; Glaser, R; Mulukutla, SR; Wilensky, RL; Abbott, JD; Williams, DO; Slater, J
2009 MAR 10 ;53(10):A66-A67, Journal of the American College of Cardiology
— id: 97554, year: 2009, vol: 53, page: A66, stat: Journal Article,

Factors related to the selection of surgical versus percutaneous revascularization in diabetic patients with multivessel coronary artery disease in the BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes) trial
Kim, Lauren J; King, Spencer B 3rd; Kent, Kenneth; Brooks, Maria Mori; Kip, Kevin E; Abbott, J Dawn; Jacobs, Alice K; Rihal, Charanjit; Hueb, Whady A; Alderman, Edwin; Sing, Ivan R Pena; Attubato, Michael J; Feit, Frederick
2009 May;2(5):384-392, JACC: Cardiovascular Interventions
OBJECTIVES: We evaluated demographic, clinical, and angiographic factors influencing the selection of coronary artery bypass graft (CABG) surgery versus percutaneous coronary intervention (PCI) in diabetic patients with multivessel coronary artery disease (CAD) in the BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes) trial. BACKGROUND: Factors guiding selection of mode of revascularization for patients with diabetes mellitus and multivessel CAD are not clearly defined. METHODS: In the BARI 2D trial, the selected revascularization strategy, CABG or PCI, was based on physician discretion, declared independent of randomization to either immediate or deferred revascularization if clinically warranted. We analyzed factors favoring selection of CABG versus PCI in 1,593 diabetic patients with multivessel CAD enrolled between 2001 and 2005. RESULTS: Selection of CABG over PCI was declared in 44% of patients and was driven by angiographic factors including triple vessel disease (odds ratio [OR]: 4.43), left anterior descending stenosis >or=70% (OR: 2.86), proximal left anterior descending stenosis >or=50% (OR: 1.78), total occlusion (OR: 2.35), and multiple class C lesions (OR: 2.06) (all p < 0.005). Nonangiographic predictors of CABG included age >or=65 years (OR: 1.43, p = 0.011) and non-U.S. region (OR: 2.89, p = 0.017). Absence of prior PCI (OR: 0.45, p < 0.001) and the availability of drug-eluting stents conferred a lower probability of choosing CABG (OR: 0.60, p = 0.003). CONCLUSIONS: The majority of diabetic patients with multivessel disease were selected for PCI rather than CABG. Preference for CABG over PCI was largely based on angiographic features related to the extent, location, and nature of CAD, as well as geographic, demographic, and clinical factors. (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes [BARI 2D]; NCT00006305)
— id: 133681, year: 2009, vol: 2, page: 384, stat: Journal Article,

Impact of gender and antithrombin strategy on early and late clinical outcomes in patients with non-ST-elevation acute coronary syndromes (from the ACUITY trial)
Lansky, Alexandra J; Mehran, Roxana; Cristea, Ecatarina; Parise, Helen; Feit, Frederick; Ohman, E Magnus; White, Harvey D; Alexander, Karen P; Bertrand, Michel E; Desmet, Walter; Hamon, Martial; Stone, Gregg W
2009 May 1;103(9):1196-1203, American journal of cardiology
Women with non-ST-elevation acute coronary syndrome are at increased risk for ischemic and bleeding complications compared with men. We examined the impact of gender and antithrombotic therapy for non-ST-elevation acute coronary syndrome on outcomes in patients in the ACUITY trial. Patients were randomized to heparin (unfractionated or enoxaparin) plus a glycoprotein IIb/IIIa inhibitor (GPI), bivalirudin plus a GPI, or bivalirudin alone. We compared major bleeding unconnected to coronary artery bypass grafting, composite ischemia (death, myocardial infarction, or revascularization), and net clinical outcome (composite ischemia or bleeding) in (1) men versus women overall and undergoing percutaneous coronary intervention (PCI) and (2) women overall and undergoing PCI by antithrombotic strategy. Of 13,819 patients enrolled, 4,157 were women (30.1%). Women had similar 30-day composite ischemia (7% vs 8%, p = 0.07) but greater 30-day rates of major bleeding (8% vs 3% p <0.0001) and net clinical outcomes (13% vs 10% p <0.0001) than men. One-year composite ischemia and mortality was similar. In women, bivalirudin compared with heparin + GPI resulted in less 30-day major bleeding (5% vs 10%, p <0.0001) but similar composite ischemia (7% vs 6%, p = 0.15). No differences were observed in rates of 1-year composite ischemia or mortality in women who received bivalirudin versus heparin + GPI. Results were similar in women undergoing PCI. In conclusion, women had similar 30-day mortality and composite ischemia but higher net clinical adverse events due to more bleeding complications than men; 1-year mortality was similar for men and women. In women, bivalirudin monotherapy compared with a GPI-based strategy resulted in significantly decreased bleeding but similar rates of 1-year composite ischemia and mortality
— id: 133685, year: 2009, vol: 103, page: 1196, stat: Journal Article,

Advanced age, antithrombotic strategy, and bleeding in non-ST-segment elevation acute coronary syndromes: results from the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial
Lopes, Renato D; Alexander, Karen P; Manoukian, Steven V; Bertrand, Michel E; Feit, Frederick; White, Harvey D; Pollack, Charles V Jr; Hoekstra, James; Gersh, Bernard J; Stone, Gregg W; Ohman, E Magnus
2009 Mar 24;53(12):1021-1030, Journal of the American College of Cardiology
OBJECTIVES: This study sought to evaluate the impact of age on outcomes in patients with moderate- and high-risk non-ST-segment elevation acute coronary syndrome (NSTE-ACS) enrolled in the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial. BACKGROUND: Aging-associated changes in physiology and metabolism may alter the risk and benefit of therapeutic strategies from that observed in younger people. METHODS: We performed a pre-specified analysis of 30-day and 1-year outcomes in 4 age groups, overall and among those undergoing percutaneous coronary intervention (PCI). RESULTS: Of 13,819 patients in the ACUITY trial, 3,655 (26.4%) were <55 years of age, 3,940 (28.5%) were 55 to 64 years of age, 3,783 (27.4%) were 65 to 74 years of age, and 2,441 (17.7%) were > or =75 years of age. Older patients had more cardiovascular risk factors and had a higher acuity at presentation. Patients age > or =75 years treated with bivalirudin alone had similar ischemic outcomes, but significantly lower rates of bleeding compared with those treated with heparin and glycoprotein IIb/IIIa inhibitors overall and in the PCI subset. The number needed to treat with bivalirudin alone to avoid 1 major bleeding event was lower in this age group (23 overall and 16 for PCI-treated patients) than in any other. CONCLUSIONS: Ischemic and bleeding complications after NSTE-ACS increase with age. Although ischemic event rates are not statistically different with either bivalirudin alone or a heparin plus glycoprotein IIb/IIIa inhibitor, bleeding complications are significantly less frequent with bivalirudin alone. Because of the substantial risk of bleeding in patients age > or =75 years, the number needed to treat to avoid 1 major bleeding event using bivalirudin alone was the lowest in the elderly group, especially among those undergoing PCI
— id: 135239, year: 2009, vol: 53, page: 1021, stat: Journal Article,

Individual Patient Risks Of Major Bleeding And Myocardial Infarction And Their Implications For Mortality And For Treatment Choice In Acute Coronary Syndromes: Findings From The ACUITY Trial
Mehran, R; Pocock, S; Clayton, T; Lansky, A; Kirtane, A; Dangas, G; Manoukian, SV; Feit, F; White, HD; Ohman, EM; Stone, GW
2009 SEP 21 ;104(6A):6D-7D, American journal of cardiology
— id: 104884, year: 2009, vol: 104, page: 6D, stat: Journal Article,

Individual Patient Risks of Major Bleeding and Myocardial Infarction and Their Implications for Mortality and for Treatment Choice in Acute Coronary Syndromes: Findings From the ACUITY Trial
Mehran, R; Pocock, S; Clayton, T; Lansky, AJ; Kirtane, A; Dangas, GD; Manouklan, SV; Feit, F; White, HD; Ohman, EM; Stone, GW
2009 NOV 3 ;120(18):S961-S961, Circulation
— id: 106980, year: 2009, vol: 120, page: S961, stat: Journal Article,

Impact of chronic kidney disease on early (30-day) and late (1-year) outcomes of patients with acute coronary syndromes treated with alternative antithrombotic treatment strategies: an ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) substudy
Mehran, Roxana; Nikolsky, Eugenia; Lansky, Alexandra J; Kirtane, Ajay J; Kim, Young-Hak; Feit, Frederick; Manoukian, Steven; Moses, Jeffrey W; Ebrahimi, Ramin; Ohman, E Magnus; White, Harvey D; Pocock, Stuart J; Dangas, George D; Stone, Gregg W
2009 Aug;2(8):748-757, JACC: Cardiovascular Interventions
OBJECTIVES: In this substudy of the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial, we investigated the relationship between chronic kidney disease (CKD) and clinical outcomes, and compared the safety and efficacy of bivalirudin monotherapy versus heparin plus a glycoprotein IIb/IIIa inhibitor (GPI). BACKGROUND: CKD is an important predictor of prognosis in the general population. The outcomes of patients with CKD and acute coronary syndromes (ACS) have not been well studied. METHODS: In the ACUITY study, 13,819 patients with moderate- and high-risk ACS undergoing an early, invasive strategy were randomly assigned to 1 of 3 antithrombin regimens: a heparin plus a GPI, bivalirudin plus a GPI, or bivalirudin monotherapy. CKD (creatinine clearance <60 ml/min) was present in 2,469 (19.1%) of 12,939 randomized patients with baseline creatinine clearance data. RESULTS: Patients with CKD had worse 30-day and 1-year clinical outcomes than those with normal renal function. There were no significant differences between bivalirudin monotherapy and heparin plus a GPI in rates of 30-day composite ischemia (11.1% vs. 9.4%, p = 0.27) and net clinical adverse outcomes (16.1% vs. 16.9%, p = 0.65). There was remarkably less major bleeding (6.2% vs. 9.8%, p = 0.008) at 30 days, but no significant difference in 1-year composite ischemia (22.0% vs. 18.9%, p = 0.10) or mortality (7.1% vs. 7.3%, p = 0.96). CONCLUSIONS: In patients with ACS, CKD is associated with higher 30-day and 1-year adverse event rates. Compared with heparin plus a GPI, the use of bivalirudin monotherapy in patients with CKD results in nonstatistically different ischemic outcomes, but significantly less 30-day major bleeding
— id: 133708, year: 2009, vol: 2, page: 748, stat: Journal Article,

Associations of major bleeding and myocardial infarction with the incidence and timing of mortality in patients presenting with non-ST-elevation acute coronary syndromes: a risk model from the ACUITY trial
Mehran, Roxana; Pocock, Stuart J; Stone, Gregg W; Clayton, Tim C; Dangas, George D; Feit, Frederick; Manoukian, Steven V; Nikolsky, Eugenia; Lansky, Alexandra J; Kirtane, Ajay; White, Harvey D; Colombo, Antonio; Ware, James H; Moses, Jeffrey W; Ohman, E Magnus
2009 Jun;30(12):1457-1466, European heart journal
AIMS: To evaluate the associations of myocardial infarction (MI) and major bleeding with 1-year mortality. Both MI and major bleeding predict 1-year mortality in patients presenting with acute coronary syndrome (ACS). However, the risk of each of these events on the magnitude and timing of mortality has not been well studied. METHODS AND RESULTS: A multivariable Cox regression model was developed relating 13 independent baseline predictors to 1-year mortality for 13 819 patients with moderate and high-risk ACS enrolled in the Acute Catheterization and Urgent Intervention Triage strategy trial. After adjustment for baseline predictors, Cox models with major bleeding and recurrent MI as time-updated covariates estimated the effect of these events on mortality hazard over time. Within 30 days of randomization, 705 patients (5.1%) had an MI, 645 (4.7%) had a major bleed; 524 (3.8%) died within a year. The occurrence of an MI was associated with a hazard ratio of 3.1 compared with patients not yet having an MI, after adjustment for baseline predictors. However, MI within 30 days markedly increased the mortality risk for the first 2 days after the event (adjusted hazard ratio of 17.6), but this risk declined rapidly post-infarct (hazard ratio of 1.4 beyond 1 month after the MI event). In contrast, major bleeding had a prolonged association with mortality risk (hazard ratio of 3.5) which remained fairly steady over time throughout 1 year. CONCLUSION: After accounting for baseline predictors of mortality, major bleeds and MI have similar overall strength of association with mortality in the first year after ACS. MI is correlated with a dramatic increase in short-term risk, whereas major bleeding correlates with a more prolonged mortality risk
— id: 147294, year: 2009, vol: 30, page: 1457, stat: Journal Article,

Gastrointestinal bleeding in patients with acute coronary syndromes: incidence, predictors, and clinical implications: analysis from the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial
Nikolsky, Eugenia; Stone, Gregg W; Kirtane, Ajay J; Dangas, George D; Lansky, Alexandra J; McLaurin, Brent; Lincoff, A Michael; Feit, Frederick; Moses, Jeffrey W; Fahy, Martin; Manoukian, Steven V; White, Harvey D; Ohman, E Magnus; Bertrand, Michel E; Cox, David A; Mehran, Roxana
2009 Sep 29;54(14):1293-1302, Journal of the American College of Cardiology
OBJECTIVES: We assessed the incidence, predictors, and outcomes of gastrointestinal bleeding (GIB) in patients with acute coronary syndromes (ACS). BACKGROUND: GIB is a potential hemorrhagic complication in patients with ACS treated with antithrombotic and/or antiplatelet medications. The clinical outcomes associated with GIB in this setting have not been systematically studied. METHODS: In the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial, 13,819 patients with moderate- and high-risk ACS, enrolled at 450 centers in 17 countries between August 2003 and December 2005, were randomized to the open-label use of 1 of 3 antithrombin regimens (heparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudin plus a glycoprotein IIb/IIIa inhibitor, or bivalirudin monotherapy). RESULTS: GIB within 30 days occurred in 178 patients (1.3%). Older age, baseline anemia, longer duration of study drug administration before angiogram, smoking, ST-segment deviation>or=1 mm, and diabetes were identified as independent predictors of GIB. On multivariable analysis, GIB was strongly associated with 30-day all-cause mortality (hazard ratio [HR]: 4.87 [interquartile range (IQR) 2.61 to 9.08], p<0.0001), cardiac mortality (HR: 5.35 [IQR 2.71 to 10.59], p<0.0001), and composite ischemia (HR: 1.94 [IQR 1.14 to 3.30], p=0.014), as well as with 1-year all-cause mortality (HR: 3.97 [IQR 2.64 to 5.99], p<0.0001), cardiac mortality (HR: 3.77 [IQR 2.14 to 6.63], p<0.0001), myocardial infarction (HR: 1.74 [IQR 1.01 to 3.02], p=0.047), and composite ischemia (HR: 1.90 [IQR 1.37 to 2.64], p=0.0001). Patients who experienced GIB had significantly higher rates of stent thrombosis compared with patients without GIB (5.8% vs. 2.4%, p=0.009). CONCLUSIONS: GIB is a serious condition in the scenario of ACS and is independently associated with mortality and ischemic complications
— id: 147282, year: 2009, vol: 54, page: 1293, stat: Journal Article,

Baseline coronary angiographic findings in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial (BARI 2D)
Schwartz, Leonard; Kip, Kevin E; Alderman, Edwin; Lu, Jiang; Bates, Eric R; Srinivas, Vankeepuram; Bach, Richard G; Mighton, Lisa D; Feit, Frederick; King, Spencer 3rd; Frye, Robert L
2009 Mar 1;103(5):632-638, American journal of cardiology
This report describes the baseline angiographic findings in the Bypass Angioplasty Revascularization Investigation (BARI) 2 Diabetes (BARI 2D) trial, a randomized study that was initiated after the original BARI trial (BARI 1). Unlike BARI 1, which compared coronary artery bypass graft surgery with coronary angioplasty (percutaneous coronary intervention) in patients with and without diabetes, BARI 2D is investigating early versus deferred revascularization as needed in selected patients with type 2 diabetes mellitus and significant stable coronary artery disease (CAD). This analysis included 1,773 patients without previous procedures. The intended mode of revascularization, percutaneous coronary intervention or coronary artery bypass graft surgery, was specified before randomization. Angiographic findings in those randomized to revascularization versus medical treatment were similar. Overall, the mean number of lesions >or=20% diameter stenosis was 4.6 +/- 2.3, and the myocardial jeopardy index was 46 +/- 24%. Patients selected for the coronary artery bypass graft stratum had a higher mean number of lesions >or=20% diameter stenosis (5.7 vs 4.0, p <0.0001) and a higher myocardial jeopardy index (61% vs 38%, p <0.0001) than those selected for the percutaneous coronary intervention stratum. Female gender, black race, and higher body mass index were associated with less extensive CAD, whereas a history of hypertension, age at entry, low-density lipoprotein cholesterol, and ankle-brachial index <or=0.9 were associated with more extensive CAD. In conclusion, BARI 2D patients, who by design have mild or no symptoms, demonstrate considerable variation in the extent of CAD and amount of jeopardized myocardium. Coronary arteriographic findings are consistent with the intent of the design of BARI 2D. Certain baseline and clinical features were associated with the extent of disease and myocardial jeopardy
— id: 95976, year: 2009, vol: 103, page: 632, stat: Journal Article,

Optimizing antithrombotic strategies in patients with concomitant indications for warfarin undergoing coronary artery stenting
Zinn, Andrew; Feit, Frederick
2009 Sep 7;104(5 Suppl):49C-54C, American journal of cardiology
The current standard in coronary artery stenting is dual antiplatelet therapy with aspirin and clopidogrel, with the duration of therapy primarily based on the use of bare metal or drug-eluting stents. The expanding patient population in whom oral anticoagulation and dual antiplatelet therapy may be indicated poses unique challenges in navigating the delicate balance between the efficacy of these therapies and bleeding risk. Although limited data exist, meaningful recommendations can be made involving individualization of these and other therapies (such as cilostazol) based on the perceived risk of thrombotic stent complications, indication for oral anticoagulant therapy, and bleeding risk
— id: 101896, year: 2009, vol: 104, page: 49C, stat: Journal Article,

Incidence and Clinical Consequence of Acquired Thrombocytopenia Following Antithrombotic Therapies in Patients with Acute Coronary Syndromes: Insights from the ACUITY Trial
Caixeta, A; Aoki, J; Dangas, GD; Mehran, R; Moses, JW; Steinhubl, SR; Feit, F; White, HD; Ohman, EM; Manoukian, SV; Prats, J; Stone, GW
2008 OCT 12 ;102(8A):49I-49I, American journal of cardiology
— id: 91405, year: 2008, vol: 102, page: 49I, stat: Journal Article,

Sex and race are associated with the finding of non-obstructive coronary artery disease in patients with acute coronary syndromes
Chokshi, NP; Berger, RL; Hochman, JS; Keller, NM; Feit, F; Attubato, MJ; Slater, JN; Pena-Sing, I; Babaev, A; Reynolds, HR
2008 MAR 11 ;51(10):A217-A217, Journal of the American College of Cardiology
— id: 78384, year: 2008, vol: 51, page: A217, stat: Journal Article,

Upstream Bivalirudin Monotherapy Results in Similar One Year Survival as Heparin Plus Glycoprotein IIb/IIIa Inhibitors in Patients With Non-ST-Elevation Acute Coronary Syndromes Undergoing Bypass Graft Surgery: A Report From the ACUITY Trial
Ebrahim, R; Manoukian, SV; Feit, F; Lincoff, AM; Dyke, C; Gersh, B; Mehran, R; Moses, JW; Stone, GW
2008 OCT 12 ;102(8A):59I-59I, American journal of cardiology
— id: 91406, year: 2008, vol: 102, page: 59I, stat: Journal Article,

Bivalirudin Monotherapy Provides Similar One-Year Survival Compared to Heparin plus GP IIb/IIIa Inhibitors Among Diabetic Patients Undergoing Percutaneous Coronary Intervention: Results from the ACUITY Trial
Feit, F; Manoukian, SV; Ohman, EM; Attubato, MJ; Mehran, R; Chew, D; White, HD; Stone, GW
2008 OCT 12 ;102(8A):1I-1I, American journal of cardiology
— id: 91403, year: 2008, vol: 102, page: 1I, stat: Journal Article,

Safety and efficacy of bivalirudin monotherapy in patients with diabetes mellitus and acute coronary syndromes: a report from the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial
Feit, Frederick; Manoukian, Steven V; Ebrahimi, Ramin; Pollack, Charles V; Ohman, E Magnus; Attubato, Michael J; Mehran, Roxana; Stone, Gregg W
2008 Apr 29;51(17):1645-1652, Journal of the American College of Cardiology
OBJECTIVES: We sought to evaluate clinical outcomes of patients with diabetes mellitus in the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial, overall and by treatment arm. BACKGROUND: In the ACUITY trial, 13,819 patients with moderate- or high-risk acute coronary syndromes (ACS) were randomized to heparin (unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibition (GPI), bivalirudin plus GPI, or bivalirudin monotherapy. Compared with heparin plus GPI, bivalirudin monotherapy resulted in similar protection from ischemic events with less major bleeding. Whether these results apply to patients with diabetes is unknown. METHODS: We evaluated the impact of diabetes on 30-day net adverse clinical outcomes (composite ischemia [death, myocardial infarction, or unplanned ischemic revascularization] or major bleeding), overall and by antithrombotic strategy. RESULTS: Diabetes was present in 3,852 randomized patients (27.9%). Compared with nondiabetic patients, diabetic patients had higher 30-day rates of net adverse clinical outcomes (12.9% vs. 10.6%; p < 0.001), composite ischemia (8.7% vs. 7.2%; p = 0.003), and major bleeding (5.7% vs. 4.2%; p < 0.001). Among diabetic patients, compared with heparin plus GPI, bivalirudin plus GPI resulted in similar rates of net adverse clinical outcomes (14.0% vs. 13.8%; p = 0.89), while bivalirudin monotherapy resulted in a similar rate of composite ischemia (7.9% vs. 8.9%; p = 0.39) and less major bleeding (3.7% vs. 7.1%; p < 0.001), yielding fewer net adverse clinical outcomes (10.9% vs. 13.8%; p = 0.02). CONCLUSIONS: Diabetic patients with ACS managed invasively have higher rates of composite ischemia and major bleeding. Compared with treatment with heparin plus GPI, bivalirudin monotherapy provides similar protection from ischemic events with less major bleeding, resulting in a significant reduction in net adverse clinical outcomes
— id: 79147, year: 2008, vol: 51, page: 1645, stat: Journal Article,

Influence of timing of clopidogrel treatment on the efficacy and safety of bivalirudin in patients with non-ST-segment elevation acute coronary syndromes undergoing percutaneous coronary intervention: an analysis of the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial
Lincoff, A Michael; Steinhubl, Steven R; Manoukian, Steven V; Chew, Derek; Pollack, Charles V Jr; Feit, Frederick; Ware, James H; Bertrand, Michel E; Ohman, E Magnus; Desmet, Walter; Cox, David A; Mehran, Roxana; Stone, Gregg W
2008 Dec;1(6):639-648, JACC: Cardiovascular Interventions
OBJECTIVES: This study sought to determine if the efficacy of bivalirudin alone versus heparin plus a glycoprotein (GP) IIb/IIIa inhibitor is dependent upon the duration of clopidogrel pre-treatment in patients undergoing percutaneous coronary intervention (PCI) in the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial. BACKGROUND: The administration of a clopidogrel loading dose several hours before PCI reduces the risk of periprocedural thrombotic events. METHODS: Patients with an acute coronary syndrome were randomized to heparin plus a GP IIb/IIIa inhibitor (control), bivalirudin plus a GP IIb/IIIa inhibitor, or bivalirudin alone. Dose and timing of clopidogrel were left to the investigator's discretion. RESULTS: Of 13,819 patients randomized, 7,789 underwent PCI. When clopidogrel was initiated at any time before angiography or within 30 min after PCI, randomization to bivalirudin alone (n = 2,284) or control (n = 2,189) was associated with similar ischemic outcomes (8.2% vs. 8.3%, risk ratio: 0.98, 95% confidence interval: 0.81 to 1.20). Those patients who received clopidogrel >30 min after PCI or not at all experienced an increase in ischemic events when randomized to bivalirudin alone (n = 290) versus control (n = 317) (14.1% vs. 8.5%, risk ratio: 1.66, 95% confidence interval: 1.05 to 2.63). Major bleeding was significantly less frequent in patients treated with bivalirudin alone. CONCLUSIONS: This post-hoc analysis suggests that in acute coronary syndrome patients, as long as clopidogrel is administered before or within 30 min of PCI treatment with bivalirudin alone is similarly effective to heparin plus a GP IIb/IIIa inhibitor in suppressing 30-day ischemic events with significantly less bleeding. If it is anticipated that clopidogrel will be given late or not at all after PCI, bivalirudin alone may be associated with worse ischemic outcomes. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes; NCT00093158)
— id: 133608, year: 2008, vol: 1, page: 639, stat: Journal Article,

Contrast-Induced Nephropathy Redefined; Impact of Any Acute Kidney Injury on Clinical Outcomes in Patients with ACS undergoing Angiography: Results from the ACUITY Trial
Mehran, R; Dangas, GD; Weisz, G; Manoukian, SV; Colombo, A; Moses, J; Feit, F; Pocock, S; Ohman, EM; Lincoff, AM; White, HD; Lansky, AJ; Stone, GW
2008 OCT 12 ;102(8A):33I-33I, American journal of cardiology
— id: 91404, year: 2008, vol: 102, page: 33I, stat: Journal Article,

The Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction (HORIZONS-AMI) Trial: study design and rationale
Mehran, Roxana; Brodie, Bruce; Cox, David A; Grines, Cindy L; Rutherford, Barry; Bhatt, Deepak L; Dangas, George; Feit, Fred; Ohman, E Magnus; Parise, Helen; Fahy, Martin; Lansky, Alexandra J; Stone, Gregg W
2008 Jul;156(1):44-56, American heart journal
BACKGROUND: Advances in coronary angioplasty and adjunct pharmacology have improved patient outcomes after primary percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI). However, several areas for improvement remain. Hemorrhagic complications, which are common in patients receiving intense anticoagulant and antiplatelet agents during primary PCI to suppress ischemia, have been strongly associated with early and late mortality. Moreover, restenosis after bare-metal stents (BMSs) frequently results in symptom recurrence and the need for repeat rehospitalization and revascularization procedures. Newer pharmacologic agents and drug-eluting stents may address both of these issues. STUDY DESIGN: In the HORIZONS-AMI trial, 3,602 patients with AMI undergoing primary PCI were prospectively randomized to unfractionated heparin plus routine use of glycoprotein (GP) IIb/IIIa inhibitors versus the direct thrombin inhibitor bivalirudin plus provisional use of GP IIb/IIIa inhibitors reserved for predefined thrombotic complications. In a second randomization, 3,011 eligible patients were randomly assigned to either a polymer-based paclitaxel-eluting stent or to an otherwise identical BMS. The study was powered for the assessment of sequential safety and efficacy end points for each specific randomization, with clinical end points assessed at 30 days, 1 year, and then annually for 5 years. SUMMARY: The ongoing HORIZONS-AMI trial will determine whether bivalirudin monotherapy reduces bleeding complications and improves overall event-free survival compared with unfractionated heparin plus the routine use of GP IIb/IIIa inhibitors in patients undergoing primary PCI for AMI. Furthermore, this study will determine whether paclitaxel-eluting stents safely reduce rates of ischemic target lesion revascularization compared with BMSs in the setting of primary PCI
— id: 147303, year: 2008, vol: 156, page: 44, stat: Journal Article,

Safety and efficacy of switching from either unfractionated heparin or enoxaparin to bivalirudin in patients with non-ST-segment elevation acute coronary syndromes managed with an invasive strategy: results from the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial
White, Harvey D; Chew, Derek P; Hoekstra, James W; Miller, Chadwick D; Pollack, Charles V Jr; Feit, Frederick; Lincoff, A Michael; Bertrand, Michel; Pocock, Stuart; Ware, James; Ohman, E Magnus; Mehran, Roxana; Stone, Gregg W
2008 May 6;51(18):1734-1741, Journal of the American College of Cardiology
OBJECTIVES: The aim of this study was to compare outcomes in patients receiving consistent unfractionated heparin (UFH)/enoxaparin (ENOX) therapy and in those switched at randomization to bivalirudin monotherapy. BACKGROUND: Crossover between UFH and ENOX has been associated with increased adverse outcomes in patients with acute coronary syndromes. The ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial demonstrated superior net clinical outcomes with similar rates of ischemia and significantly less major bleeding with bivalirudin monotherapy compared with UFH/ENOX plus a glycoprotein (GP) IIb/IIIa inhibitor. It is unknown if these results would be preserved in patients switched from UFH/ENOX to bivalirudin monotherapy. METHODS: We compared composite ischemia, major bleeding, and net clinical outcomes at 30 days in patients receiving consistent UFH/ENOX therapy and in those switched at randomization from pre-treatment with UFH/ENOX to bivalirudin monotherapy. We also compared outcomes in patients naive to antithrombin therapy who were randomized to UFH/ENOX or bivalirudin monotherapy. RESULTS: Two thousand one hundred thirty-seven patients received consistent UFH/ENOX (UFH n = 1,294, ENOX n = 843), and 2,078 patients pre-treated with UFH/ENOX were switched to bivalirudin. Patients switching to bivalirudin had similar rates of ischemia (6.9% vs. 7.4%, p = 0.52), less major bleeding (2.8% vs. 5.8%, p < 0.01), and improved net clinical outcomes (9.2% vs. 11.9%, p < 0.01) than those on consistent UFH/ENOX plus a GP IIb/IIIa inhibitor. Patients naive to antithrombin therapy who were administered bivalirudin (n = 1,427) had similar rates of ischemia (6.2% vs. 5.5%, p = 0.47), less major bleeding (2.5% vs. 4.9%, p < 0.001), and similar net clinical outcomes (8.0% vs. 9.4%, p = 0.17) compared with naive patients administered UFH/ENOX plus a GP IIb/IIIa inhibitor (n = 1,462). CONCLUSIONS: Switching from UFH/ENOX to bivalirudin monotherapy results in comparable ischemic outcomes and an approximately 50% reduction in major bleeding compared with consistent UFH/ENOX plus a GP IIb/IIIa inhibitor. Patients naive to antithrombin therapy administered bivalirudin monotherapy had a significant reduction in bleeding and similar rates of ischemia compared with naive patients initiated with UFH or ENOX plus a GP IIb/IIIa inhibitor
— id: 95977, year: 2008, vol: 51, page: 1734, stat: Journal Article,

Long-term outcomes in non-diabetic patients with metabolic syndrome undergoing revascularization for multi-vessel coronary artery disease
Yatskar, Leonid; Holper, Elizabeth; Bansilal, Sameer; Schwartzbard, Arthur; Lombardero, Manuel; Ramanathan, Krishnan; Feit, Frederick; Fisher, Edward; Faxon, David; Hochman, Judith S; Farkouh, Michael E
2008 Jun;198(2):389-395, Atherosclerosis
AIM: The influence of metabolic syndrome (MS) on long-term mortality and morbidity in multi-vessel coronary artery disease (MV-CAD) is unclear. We studied the impact of MS on long-term outcomes in non-diabetic patients (NDM) with MV-CAD undergoing coronary revascularization in the Bypass Angioplasty Revascularization Investigation (BARI) trial and registry. METHODS: BARI trial and registry patients were separated into those with diabetes (DM) and those without. NDM fulfilling the NCEP definition of MS were identified. Ten year follow-up data were obtained on mortality, MI and development of diabetes. The data were analyzed using Cox proportional hazard modeling. RESULTS: In the BARI trial and registry 2962 NDM were identified. Of those, 510 patients had 3 or more components of the BARI-modified NCEP definition for MS, while 445 patients had 2 components of the definition and were classified as the 'mixed group'. Compared to patients without MS, both MS group (RR=3.2, p<0.0001) and the mixed group (RR=1.9, p=0.02) had a higher incidence of DM over the 10-year follow-up. Type 2 DM was found to be highly associated with 10-year mortality (RR=1.65, p<0.0001). However, there was no statistically significant difference in the rate of death or MI at 5 and 10 years between NDM with or without MS. In multivariate analysis, the presence of MS was not associated with 10-year mortality in the BARI population (RR=0.93, p=0.62). CONCLUSION: In this BARI follow-up study, we have affirmed the role of MS in predicting the development of diabetes in NDM at baseline. The 10-year risk of mortality and MI was not greater in NDM with MS who had MV-CAD and underwent revascularization, compared to patients without MS. Further studies to evaluate MS patients with MV-CAD undergoing coronary revascularization are warranted
— id: 79378, year: 2008, vol: 198, page: 389, stat: Journal Article,

Preoperative thienopyridine use in patients with non-ST elevation acute coronary syndromes undergoing coronary artery bypass surgery reduces adverse ischemic events: One-year results from the ACUITY trial
Ebrahimi, R; Feit, F; Manoukian, SV; Lincoff, AM; Dyke, C; Gersh, BJ; Mehran, R; Moses, J; Stone, GW
2007 OCT 20 ;100(8A):67L-67L, American journal of cardiology
— id: 87221, year: 2007, vol: 100, page: 67L, stat: Journal Article,

Predictors and impact of major hemorrhage on mortality following percutaneous coronary intervention from the REPLACE-2 Trial
Feit, Frederick; Voeltz, Michele D; Attubato, Michael J; Lincoff, A Michael; Chew, Derek P; Bittl, John A; Topol, Eric J; Manoukian, Steven V
2007 Nov 1;100(9):1364-1369, American journal of cardiology
Patients undergoing percutaneous coronary intervention (PCI) have a significant risk of hemorrhagic complications. Predictors of major hemorrhage and its relation to mortality in PCI are not well defined. Baseline and periprocedural predictors of major hemorrhage and its impact on mortality in patients undergoing elective or urgent PCI randomly assigned to heparin plus planned glycoprotein IIb/IIIa inhibitor (GPI) versus bivalirudin plus provisional GPIs in the REPLACE-2 Trial were determined. Of 6,001 patients, 3.2% experienced a major hemorrhage. Independent baseline predictors of major hemorrhage included advanced age, female gender, impaired creatinine clearance, and anemia. Independent periprocedural predictors of major hemorrhage included treatment with heparin plus GPI, increased procedural duration, provisional use of GPI, increased time to sheath removal, length of intensive care unit stay, and use of an intra-aortic balloon pump (all p <0.05). Mortality rates were higher in patients with than without major hemorrhage at 30 days (5.1% vs 0.2%), 6 months (6.7% vs 1.0%), and 1 year (8.7% vs 1.9%; p <0.001 for all). Furthermore, major hemorrhage was an independent predictor of 1-year mortality (odds ratio 2.66, 95% confidence interval 1.44 to 4.92, p = 0.002). In conclusion, in patients undergoing elective or urgent PCI, major hemorrhage was an independent predictor of 1-year mortality. A number of baseline and periprocedural factors independently predicted major hemorrhage, including treatment with heparin plus GPI
— id: 75393, year: 2007, vol: 100, page: 1364, stat: Journal Article,

Comparison of catheterization lab initiated abciximab and double-bolus eptifibatide during percutaneous coronary intervention in acute coronary syndromes: an ACUITY substudy
Kirtane, AJ; Parise, H; Mehran, R; Moses, JW; Fahy, M; Bertrand, ME; Ohman, EM; White, HD; Feit, F; Colombo, A; McLaurin, BT; Cox, DA; Ware, JH; Pocock, S; Stone, GW
2007 OCT 16 ;116(16):629-630, Circulation
— id: 75980, year: 2007, vol: 116, page: 629, stat: Journal Article,

Predictors of major vascular access site complications in patients with acute coronary syndromes undergoing percutaneous coronary intervention: Insights from the ACUITY trial
Manoukia, SV; Fazel, R; Sanborn, TA; Ebrahimi, R; Feit, F; Hamon, M; Voeltz, MD; Dangas, GD; Moses, JW; King, SB; White, HD; Ohman, EM; Mehran, R; Stone, GW
2007 OCT 20 ;100(8A):153L-154L, American journal of cardiology
— id: 87222, year: 2007, vol: 100, page: 153L, stat: Journal Article,

Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coronary syndromes: an analysis from the ACUITY Trial
Manoukian, Steven V; Feit, Frederick; Mehran, Roxana; Voeltz, Michele D; Ebrahimi, Ramin; Hamon, Martial; Dangas, George D; Lincoff, A Michael; White, Harvey D; Moses, Jeffrey W; King, Spencer B 3rd; Ohman, E Magnus; Stone, Gregg W
2007 Mar 27;49(12):1362-1368, Journal of the American College of Cardiology
OBJECTIVES: The purpose of this study was to determine the predictors of major bleeding and the impact of major bleeding on outcomes, including mortality, in acute coronary syndromes (ACS). BACKGROUND: Whether major bleeding independently predicts mortality in patients with ACS undergoing an early invasive strategy is undefined. METHODS: Patients (n = 13,819) with moderate- and high-risk ACS were randomized to heparin (unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibition (GPI), bivalirudin plus GPI, or bivalirudin monotherapy (plus provisional GPI). Logistic regression was used to determine predictors of 30-day major bleeding and mortality. RESULTS: Major bleeding rates in patients treated with heparin plus GPI were higher versus bivalirudin monotherapy (5.7% vs. 3.0%, p < 0.001) and similar versus bivalirudin plus GPI (5.7% vs. 5.3%, p = 0.38). Independent predictors of major bleeding were advanced age, female gender, diabetes, hypertension, renal insufficiency, anemia, no prior percutaneous coronary intervention, cardiac biomarker elevation, ST-segment deviation >/=1 mm, and treatment with heparin plus GPI versus bivalirudin monotherapy. Patients with major bleeding had higher 30-day rates of mortality (7.3% vs. 1.2%, p < 0.0001), composite ischemia (23.1% vs. 6.8%, p < 0.0001), and stent thrombosis (3.4% vs. 0.6%, p < 0.0001) versus those without major bleeding. Major bleeding was an independent predictor of 30-day mortality (odds ratio 7.55, 95% confidence interval 4.68 to 12.18, p < 0.0001). CONCLUSIONS: Major bleeding is a powerful independent predictor of 30-day mortality in patients with ACS managed invasively. Several factors independently predict major bleeding, including treatment with heparin plus GPI compared with bivalirudin monotherapy. Knowledge of these findings might be useful to reduce bleeding risk and improve outcomes in ACS
— id: 95980, year: 2007, vol: 49, page: 1362, stat: Journal Article,

Major bleeding is associated with increased one-year mortality and ischemic events in patients with acute coronary syndromes undergoing percutaneous coronary intervention: The ACUITY trial
Manoukian, SV; Feit, F; Voeltz, MD; Dangas, GD; Ebrahimi, R; Hamon, M; Chew, DP; Desmet, W; Steinhubl, SR; Lincoff, AM; King, SB; Ohman, EM; White, HD; Mehran, R; Stone, GW
2007 OCT 20 ;100(8A):154L-154L, American journal of cardiology
— id: 87223, year: 2007, vol: 100, page: 154L, stat: Journal Article,

Impact of the ACUITY and TIMI major bleeding definitions on one-year mortality in patients with acute coronary syndromes
Manoukian, SV; Feit, F; Voeltz, MD; Ebrahimi, R; Hamon, M; Chew, DP; Dangas, GD; Desmet, W; Lincoff, AM; Moses, JW; Pollack, CV; Hoekstra, JW; King, SB; White, HD; Ohman, EM; Mehran, R; Stone, GW
2007 OCT 16 ;116(16):482-482, Circulation
— id: 75972, year: 2007, vol: 116, page: 482, stat: Journal Article,

Impact of anemia on one-year ischemic events and mortality among patients with acute coronary syndromes undergoing percutaneous coronary intervention
Manoukian, SV; Voeltz, MD; Dangas, GD; Feit, F; Fazel, R; Ebrahimi, R; Hamon, M; Lincoff, AM; Moses, JW; King, SB; White, HD; Ohman, EM; Mehran, R; Stone, GW
2007 OCT 20 ;100(8A):28L-28L, American journal of cardiology
— id: 87217, year: 2007, vol: 100, page: 28L, stat: Journal Article,

Impact of transfusion on one-year ischemic events and mortality among patients with acute coronary syndromes undergoing percutaneous coronary intervention
Manoukian, SV; Voeltz, MD; Feit, F; Dangas, GD; Fazel, R; Ebrahimi, R; Hamon, M; Lincoff, AM; Moses, JW; King, SB; White, HD; Ohman, EM; Mehran, R; Stone, GW
2007 OCT 20 ;100(8A):54L-55L, American journal of cardiology
— id: 87219, year: 2007, vol: 100, page: 54L, stat: Journal Article,

Long-term outcomes of patients with acute coronary syndromes and chronic renal insufficiency undergoing percutaneous coronary intervention and being treated with bivalirudin vs heparin plus a glycoprotein IIb/IIIa inhibitor: Results from the randomized ACUITY Trial
Mehran, R; Kirlone, AJ; Dangas, GD; Ohman, EM; Pocock, SJ; Gersh, B; Bertrand, ME; Hamon, M; Manoukian, SV; Hoekstra, J; Pollack, CV; Desmet, W; Feit, F; Stella, J; Cequier, AR; Stuckey, T; Cohen, D; Lanskk, AJ; Stone, GW
2007 OCT 20 ;100(8A):27L-27L, American journal of cardiology
— id: 87215, year: 2007, vol: 100, page: 27L, stat: Journal Article,

Long-term outcomes of acute coronary syndrome patients with chronic renal insufficiency treated with bivalirudin vs heparin plus a glycoprotein Ilb/Illa inhibitor: one year results from the randomized ACUITY trial
Mehran, R; Kirtane, AJ; Dangas, GD; Ohman, EM; Pocock, S; Gersh, BJ; Bertrand, ME; Hamon, M; Manoukian, SV; Hoekstra, J; Pollack, CV; Desmet, W; Feit, F; Stella, J; Cequier, AR; Stuckey, T; Cohen, DJ; Lansky, AJ; Stone, GW
2007 OCT 16 ;116(16):483-483, Circulation
— id: 75973, year: 2007, vol: 116, page: 483, stat: Journal Article,

Clopidogrel pretreatment versus clopidogrel exposure prior to PCI in the ACUITY Trial: Does it really matter?
Steinhubl, S; Feit, F; Colombo, A; Ebrahimi, R; Cox, DA; McLaurin, BT; Mehran, R; Dongas, GD; Manoukian, SV; White, HD; Lincoff, AM; Moses, JW; Bertrand, ME; Ohman, EM; Desmet, W; Stone, GW
2007 OCT 20 ;100(8A):27L-28L, American journal of cardiology
— id: 87216, year: 2007, vol: 100, page: 27L, stat: Journal Article,

Antithrombotic strategies in patients with acute coronary syndromes undergoing early invasive management: one-year results from the ACUITY trial
Stone, Gregg W; Ware, James H; Bertrand, Michel E; Lincoff, A Michael; Moses, Jeffrey W; Ohman, E Magnus; White, Harvey D; Feit, Frederick; Colombo, Antonio; McLaurin, Brent T; Cox, David A; Manoukian, Steven V; Fahy, Martin; Clayton, Tim C; Mehran, Roxana; Pocock, Stuart J
2007 Dec 5;298(21):2497-2506, JAMA
CONTEXT: At 30-day follow-up, patients with moderate- and high-risk acute coronary syndromes (ACS) undergoing early invasive treatment in the ACUITY trial with bivalirudin monotherapy vs heparin plus glycoprotein (GP) IIb/IIIa inhibitors had noninferior rates of adverse ischemic events with reduced rates of major bleeding. Deferred upstream use of GP IIb/IIIa inhibitors for selective administration to patients undergoing percutaneous coronary intervention (PCI) resulted in a significant reduction in major bleeding, although a small increase in composite ischemia could not be excluded. OBJECTIVE: To determine 1-year ischemic outcomes for patients in the ACUITY trial. DESIGN, SETTING, AND PATIENTS: A prospective, randomized, open-label trial with 1-year clinical follow-up at 450 academic and community-based institutions in 17 countries. A total of 13,819 patients with moderate- and high-risk ACS undergoing invasive treatment were enrolled between August 23, 2003, and December 5, 2005. INTERVENTIONS: Patients were assigned to heparin plus GP IIb/IIIa inhibitors (n = 4603), bivalirudin plus GP IIb/IIIa inhibitors (n = 4604), or bivalirudin monotherapy (n = 4612). Of these patients, 4605 were assigned to routine upstream GP IIb/IIIa administration and 4602 were deferred to selective GP IIb/IIIa inhibitor administration. MAIN OUTCOME MEASURE: Composite ischemia (death, myocardial infarction, or unplanned revascularization for ischemia) at 1 year. RESULTS: Composite ischemia at 1 year occurred in 15.4% of patients assigned to heparin plus GP IIb/IIIa inhibitors and 16.0% assigned to bivalirudin plus GP IIb/IIIa inhibitors (compared with heparin plus GP IIb/IIIa inhibitors, HR, 1.05; 95% CI, 0.95-1.16; P = .35), and 16.2% assigned to bivalirudin monotherapy (HR, 1.06; 95% CI, 0.95-1.17; P = .29). Mortality at 1 year occurred in an estimated 3.9% of patients assigned to heparin plus GP IIb/IIIa inhibitors, 3.9% assigned to bivalirudin plus GP IIb/IIIa inhibitors (HR, 0.99; 95% CI, 0.80-1.22; P = .92), and 3.8% assigned to bivalirudin monotherapy (HR, 0.96; 95% CI, 0.77-1.18; P = .67). Composite ischemia occurred in 16.3% of patients assigned to deferred use compared with 15.2% of patients assigned to upstream administration (HR, 1.08; 95% CI, 0.97-1.20; P = .15). CONCLUSIONS: At 1 year, no statistically significant difference in rates of composite ischemia or mortality among patients with moderate- and high-risk ACS undergoing invasive treatment with the 3 therapies was found. There was no statistically significant difference in the rates of composite ischemia between patients receiving routine upstream administration of GP IIb/IIIa inhibitors vs deferring their use for patients undergoing PCI. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00093158
— id: 95978, year: 2007, vol: 298, page: 2497, stat: Journal Article,

Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial
Stone, Gregg W; White, Harvey D; Ohman, E Magnus; Bertrand, Michel E; Lincoff, A Michael; McLaurin, Brent T; Cox, David A; Pocock, Stuart J; Ware, James H; Feit, Frederick; Colombo, Antonio; Manoukian, Steven V; Lansky, Alexandra J; Mehran, Roxana; Moses, Jeffrey W
2007 Mar 17;369(9565):907-919, Lancet
BACKGROUND: The aim of this study was to assess anticoagulation with the direct thrombin inhibitor bivalirudin during percutaneous coronary intervention in individuals with moderate and high-risk acute coronary syndromes. METHODS: 13,819 individuals in the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial were prospectively randomly assigned to receive heparin (unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibitors, bivalirudin plus glycoprotein IIb/IIIa inhibitors, or bivalirudin alone. Of these individuals, 7789 underwent percutaneous coronary intervention after angiography. The effect of the three regimens on the primary 30-day endpoints of composite ischaemia (death, myocardial infarction, or unplanned revascularisation for ischaemia), major bleeding, and net clinical outcomes (composite ischaemia or major bleeding) was assessed in this subgroup. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, with the number NCT00093158. FINDINGS: Of the individuals who underwent percutaneous coronary intervention, 2561 received heparin plus glycoprotein IIb/IIIa inhibitors, 2609 received bivalirudin plus glycoprotein IIb/IIIa inhibitors, and 2619 received bivalirudin alone. 26 (0.3%) individuals dropped out or were lost to follow-up. There was no significant difference in the proportion of individuals with composite ischaemia, major bleeding, or net clinical outcomes at 30 days between those who received bivalirudin plus glycoprotein IIb/IIIa inhibitors and those who received heparin plus glycoprotein IIb/IIIa inhibitors (composite ischaemia: 243 [9%] patients vs 210 [8%] patients, p=0.16; major bleeding: 196 [8%] patients vs 174 [7%] patients, p=0.32; net clinical outcomes: 389 [15%] patients vs 341 [13%] patients, p=0.1). Rates of composite ischaemia were much the same in those who received bivalirudin alone and those who received heparin plus glycoprotein IIb/IIIa inhibitors (230 [9%] patients vs 210 [8%] patients, p=0.45); however, there were significantly fewer individuals who experienced major bleeding among those who received bivalirudin alone than among those who received heparin plus glycoprotein IIb/IIIa inhibitors (92 [4%] patients vs 174 [7%] patients, p<0.0001, relative risk 0.52, 95% CI 0.40-0.66), resulting in a trend towards better 30-day net clinical outcomes (303 [12%] patients vs 341 [13%] patients, p=0.057; 0.87, 0.75-1.00). INTERPRETATION: Substitution of unfractionated heparin or enoxaparin with bivalirudin results in comparable clinical outcomes in patients with moderate and high-risk acute coronary syndromes treated with glycoprotein IIb/IIIa inhibitors in whom percutaneous coronary intervention is done. Anticoagulation with bivalirudin alone suppresses adverse ischaemic events to a similar extent as does heparin plus glycoprotein IIb/IIIa inhibitors, while significantly lowering the risk of major haemorrhagic complications
— id: 95981, year: 2007, vol: 369, page: 907, stat: Journal Article,

Effect of anemia on hemorrhagic complications and mortality following percutaneous coronary intervention
Voeltz, Michele D; Patel, Amar D; Feit, Frederick; Fazel, Reza; Lincoff, A Michael; Manoukian, Steven V
2007 Jun 1;99(11):1513-1517, American journal of cardiology
The relation across anemia, hemorrhagic complications, and mortality associated with percutaneous coronary intervention (PCI) is unclear. We reviewed the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 Trial, which compared bivalirudin plus provisional glycoprotein IIb/IIIa blockade with heparin plus planned glycoprotein IIb/IIIa blockade in patients undergoing urgent or elective PCI. Of the 6,010 patients randomized in REPLACE-2, 1,371 (23%) were anemic. Major bleeding was more common in anemic than in nonanemic patients (4.9% vs 2.8%, p = 0.0001). In anemic patients, treatment with bivalirudin (n = 678) resulted in a lower risk of major bleeding versus heparin plus glycoprotein IIb/IIIa blockade (n = 693, 3.5% vs 6.2%, p = 0.0221). Mortality was higher in anemic patients than in nonanemic patients at 30 days (0.9% vs 0.2%, p <0.0001), 6 months (2.6% vs 0.7%, p <0.0001), and 1 year (4.3% vs 1.5%, p <0.0001). There were no differences between anemic and nonanemic patients with regard to ischemic complications at 30 days. Although anemic patients had higher mortality rates, proportions of cardiovascular and noncardiovascular mortalities were equal in anemic and nonanemic patients. In conclusion, anemic patients undergoing PCI have an increased risk of mortality and major bleeding, but not of ischemic events, and the use of bivalirudin with provisional glycoprotein IIb/IIIa blockade decreases the risk of hemorrhagic complications compared with heparin plus planned glycoprotein IIb/IIIa blockade
— id: 95979, year: 2007, vol: 99, page: 1513, stat: Journal Article,

Safety and efficacy of switching from either unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor to bivalirudin monotherapy in patients with non-ST elevation acute coronary syndromes managed with an invasive strategy: Results from the randomized ACUITY trial
White, H; Chew, DP; Hoekstra, JW; Pollack, CV; Feit, F; Ohman, EM; Mehran, R; Miller, C; Stone, GW
2007 OCT 20 ;100(8A):63L-63L, American journal of cardiology
— id: 87220, year: 2007, vol: 100, page: 63L, stat: Journal Article,

Safety and efficacy of bivalirudin with and without glycoprotein IIb/IIIa inhibitors in patients with acute coronary syndromes undergoing percutancous coronary intervention: One year results from the randomized ACUITY trial
White, HD; Ohman, EM; Lincoff, AM; Bertrand, ME; Colombo, A; McLaurin, BT; Cox, DA; Pocock, SJ; Ware, JH; Feit, F; Manoukian, SV; Lansky, AJ; Mehran, R; Moses, JW; Stone, GW
2007 OCT 20 ;100(8A):53L-53L, American journal of cardiology
— id: 87218, year: 2007, vol: 100, page: 53L, stat: Journal Article,

Access site hematoma requiring blood transfusion predicts mortality in patients undergoing percutaneous coronary intervention: data from the National Heart, Lung, and Blood Institute Dynamic Registry
Yatskar, Leonid; Selzer, Faith; Feit, Fredrick; Cohen, Howard A; Jacobs, Alice K; Williams, David O; Slater, James
2007 Jun 1;69(7):961-966, Catheterization & cardiovascular interventions
OBJECTIVE: To determine both the etiology of and outcomes associated with access site hematoma requiring transfusion (HRT) in patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: Access site hematoma in the setting of PCI is the most frequent periprocedural complication (2-12%). Antiplatelet and antithrombin therapy is designed to lower the incidence of adverse ischemic events while maintaining an acceptable rate of hemorrhagic complications. METHODS: This was a prospective, multi-center, cohort study of consecutive patients undergoing PCI during 3 NHLBI Dynamic Registry recruitment waves (1997-2002). The primary endpoints included the incidence of HRT, in-hospital death, and death at 1-year. RESULTS: The incidence of HRT was 1.8% and femoral access was common. Older age, lower BMI, female sex, concomitant renal, cerebrovascular, peripheral vascular, and pulmonary disease were significantly associated with HRT. Glycoprotein IIb/IIIa inhibitors, thrombolytic therapy, and postprocedure heparin were more commonly used in HRT patients, but there was no difference in thienopiridiene use. Attempted lesions in patients developing HRT were more often calcified, thrombotic, located in an ostial location, or class B2 or C. In-hospital mortality and 1-year death rate was 9 and 4.5 times higher in HRT patients respectively. Following adjustment, HRT remained independently associated with in-hospital mortality (OR 3.59, 95% CI 1.66-7.77) and 1-year death (hazard ratio [HR] 1.65, 95% CI 1.01-2.70, P = 0.048). Independent predictors of HRT included age, female sex, IIb/IIIa inhibitors, thrombolytic agents, and concomitant conditions. CONCLUSIONS: Access site complications, especially HRT, remain a very important predictor of adverse procedural success and patient outcome
— id: 73399, year: 2007, vol: 69, page: 961, stat: Journal Article,

Outcomes in elderly patients undergoing PCI treated with bivalirudin monotherapy versus glycoprotein IIb/IIIa inhibitors with hepaiin or LM
Alexander, KP; Ohman, EM; Bertrand, ME; Feit, F; Pollack, CV; Hoekstra, J; Gersh, BJ; White, HD; Stone, GW
2006 OCT 22 ;98(8A):18M-18M, American journal of cardiology
— id: 98058, year: 2006, vol: 98, page: 18M, stat: Journal Article,

Angiographic adverse events, creatine kinase-MB elevation, and ischemic end points complicating percutaneous coronary intervention (a REPLACE-2 substudy)
Blankenship, James C; Haldis, Tom; Feit, Frederick; Hu, Tingfei; Kleiman, Neal S; Topol, Eric J; Lincoff, A Michael
2006 Jun 1;97(11):1591-1596, American journal of cardiology
Several angiographic adverse events during coronary balloon angioplasty have been associated with increased creatine kinase-MB (CK-MB) enzymes and adverse clinical outcomes. The significance of angiographic adverse events in the stent era has not been widely studied. We analyzed 10 types of angiographic adverse events that were reported in the 6,010-patient Second Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE-2) trial to determine their relation to CK-MB elevation and clinical ischemic end points after percutaneous coronary intervention (PCI). Angiographic adverse events occurred in 9.1% of REPLACE-2 patients. Most (8 of 10) types of angiographic adverse events were associated with an increased risk of increased CK-MB (p <0.001 for each), and 47% of all patients with an angiographic adverse event developed increased CK-MB. Logistic regression analysis showed that the strongest predictor of death, myocardial infarction, or revascularization at 6 months was the occurrence of an angiographic adverse event during PCI (odds ratio 1.9, 95% confidence interval 1.6 to 2.4, p <0.001). Side branch closure, abrupt closure, any decreased flow during the procedure, angiographic distal embolization, and perforation or tamponade were individual predictors of the occurrence of the combined clinical ischemic end point at 6-month follow-up (p <0.005 for each). In conclusion, most angiographic adverse events during PCI are associated with increased CK-MB and are powerful predictors of adverse clinical events within 6 months
— id: 95984, year: 2006, vol: 97, page: 1591, stat: Journal Article,

Which patients with diabetes mellitus and multivessel coronary artery disease are selected for bypass surgery rather than percutaneous coronary intervention? Results from BARI-2D
Feit, F; Kim, LJ; Attubato, MJ; Jacobs, AK; Faxon, D; Rihal, C; Sing, IRP; Abbott, JD; Kent, K; King, SB; Kip, K
2006 OCT 31 ;114(18):435-435, Circulation
— id: 69554, year: 2006, vol: 114, page: 435, stat: Journal Article,

Bivalinudin monotherapy improves 30 day clinical outcomes in diabetics with acute coronary syndrome (ACS). Report from the ACUITY trial
Feit, F; Manoukian, SV; Ebrahimi, R; Pollack, CV; Ohman, EM; Attubato, MJ; Mehran, R; Stone, GW
2006 OCT 31 ;114(18):551-551, Circulation
— id: 69558, year: 2006, vol: 114, page: 551, stat: Journal Article,

Is bivalirudin monotherapy sufficient for diabetic patients with acute coronary syndrome (ACS) undergoing PCI?
Feit, F; Manoukian, SV; Ebrahimi, R; Pollack, CV; Ohman, EM; Attubato, MJ; Mehran, R; Stone, GW
2006 OCT 22 ;98(8A):14M-14M, American journal of cardiology
— id: 70768, year: 2006, vol: 98, page: 14M, stat: Journal Article,

Major bleeding is associated with increased short-term mortality and ischemic complications in non-ST elevation acute coronary syndromes: The ACUITY trial
Manoukian, SV; Voeltz, MD; Feit, F; Ebrahimi, R; Mehran, R; Nikolsky, E; Moses, JW; Lincoff, AM; King, SB; Stone, GW
2006 OCT 31 ;114(18):551-552, Circulation
— id: 69559, year: 2006, vol: 114, page: 551, stat: Journal Article,

Transfusion is associated with increased 30-day mortality and ischemic complications in non-ST elevation acute coronary syndromes: The ACUITY trial
Manoukian, SV; Voeltz, MD; Feit, F; Mehran, R; Dangas, GD; Nikolsky, E; Lincoff, AM; King, SB; Ohman, EM; Stone, GW
2006 OCT 22 ;98(8A):1M-1M, American journal of cardiology
— id: 70767, year: 2006, vol: 98, page: 1M, stat: Journal Article,

Major bleeding is associated with increased 30-day mortality and ischemic complications in patients with non-ST elevation acute coronary syndromes undergoing percutaneous coronary intervention: The ACUITY trial
Manoukian, SV; Voeltz, MD; Feit, F; Mehran, R; Nikolsky, E; Dangas, GD; Ebrahimi, R; Lincoff, AM; King, SB; Stone, GW
2006 OCT 22 ;98(8A):45M-45M, American journal of cardiology
— id: 70771, year: 2006, vol: 98, page: 45M, stat: Journal Article,

Eptifibatide plus heparin increases the risk of major and minor hemorrhagic complications compared to bivalirudin in patients with normal renal function undergoing percutaneous coronary intervention
McDaniel, MC; Fazel, R; Voeltz, MD; Feit, F; Lincoff, AM; Manoukian, SV
2006 OCT 31 ;114(18):731-731, Circulation
— id: 69562, year: 2006, vol: 114, page: 731, stat: Journal Article,

Drug eluting stents in patients with acute coronary syndromes undergoing percutaneous coronary intervention: The ACUITY trial
Mehran, R; Moses, JW; Nikolsky, E; Dangas, G; Manoukian, S; White, HD; Ohman, EM; Bertrand, ME; Lincoff, AM; McLaurin, BT; Cox, DA; Gersh, B; Pocock, SJ; Ware, JH; Feit, F; Colombo, A; Stone, GW
2006 OCT 22 ;98(8A):27M-27M, American journal of cardiology
— id: 70769, year: 2006, vol: 98, page: 27M, stat: Journal Article,

Angiographic findings in the of the acute catheterization and urgent intervention triage strategY (ACUITY) trial
Mori, K; Lansky, AJ; Costa, RA; Bertrand, M; Feit, F; Pietras, C; Cristea, E; Pocock, S; Ohman, M; Stone, GW
2006 OCT 22 ;98(8A):144M-145M, American journal of cardiology
— id: 70772, year: 2006, vol: 98, page: 144M, stat: Journal Article,

Decrease in hemoglobin in the absence of overt bleeding after percutaneous coronary intervention is a predictor of one-year mortality
Nikolsky, E; Lincoff, M; Harrington, RA; Bittle, JA; Feit, F; Solinas, E; Pucelikova, T; Agahtehrani, A; Costa, J; Kesanakurthy, V; Kimura, M; Mehran, R; Dangas, G; Stone, GW
2006 OCT 22 ;98(8A):31M-31M, American journal of cardiology
— id: 70770, year: 2006, vol: 98, page: 31M, stat: Journal Article,

Outcomes in elderly patients treated with bivalirudin monotherapy versus glycoprotein IIb/IIIa inhibitors with heparin or LM
Ohman, EM; Bertrand, ME; Feit, F; White, HD; Stone, GW; Pollack, CV; Hoekstra, J; Gersh, BJ
2006 OCT 31 ;114(18):701-701, Circulation
— id: 69560, year: 2006, vol: 114, page: 701, stat: Journal Article,

Outcomes of patients with acute coronary syndromes who are treated with bivalirudin during percutaneous coronary intervention: an analysis from the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE-2) trial
Rajagopal, Vivek; Lincoff, A Michael; Cohen, David J; Gurm, Hitinder S; Hu, Tingfei; Desmet, Walter J; Kleiman, Neal S; Bittl, John A; Feit, Frederick; Topol, Eric J
2006 Jul;152(1):149-154, American heart journal
BACKGROUND: The REPLACE-2 trial demonstrated that bivalirudin with provisional glycoprotein IIb/IIIa (GPIIb/IIIa) inhibition is not inferior to heparin plus GPIIb/IIIa inhibition in patients undergoing percutaneous coronary intervention. The extent to which this applies to patients with acute coronary syndromes (ACS) is unclear. Therefore, we sought to determine if bivalirudin has similar efficacy in ACS patients as compared with 'stable' patients in the REPLACE-2 trial. METHODS: We analyzed the outcomes of ACS patients compared with stable patients and the outcomes of ACS patients according to whether or not they had received bivalirudin, including the economic costs. The trial enrolled 1351 ACS patients (myocardial infarction within 7 days or unstable angina within 48 hours, but not on ongoing GPIIb/IIIa or heparin therapy) and 4554 stable patients. RESULTS: Patients with ACS had a similar rate of death or myocardial infarction at 30 days compared to stable patients (7.2% vs 6.7%, P = .51) and death at 1 year (1.6% vs 2.2%, P = .169), but a higher rate of urgent coronary artery bypass graft at 30 days (1.0% vs 0.3%, P = .002). Patients with ACS treated with bivalirudin had a similar rate of 30-day death, myocardial infarction, or urgent revascularization compared with ACS patients treated with heparin and GPIIb/IIIa inhibitors (8.7% vs 8.0%, P = .616) and death at 1 year (1.5% vs 1.8%, P = .701), but a higher rate of revascularization at 6 months (12% vs 8.4%, P = .04). Patients with ACS treated with bivalirudin had less major bleeding than ACS patients treated with heparin and GPIIb/IIIa inhibitors, although this was not statistically significant (2.7% vs 4.5%, P = .07). Mean 30-day costs for patients with ACS were dollar 12415 for those treated with bivalirudin and dollar 12806 for those treated with heparin plus GPIIb/IIIa inhibitors (P = .022). CONCLUSION: Bivalirudin with provisional GPIIb/IIIa inhibitor use in low-risk ACS patients (not receiving preprocedural GPIIb/IIIa blockade) appears to provide similar protection against death and myocardial infarction as the combination of heparin and GPIIb/IIIa inhibitors, although we observed a higher rate of revascularization at 6 months
— id: 95983, year: 2006, vol: 152, page: 149, stat: Journal Article,

Bivalirudin for patients with acute coronary syndromes
Stone, Gregg W; McLaurin, Brent T; Cox, David A; Bertrand, Michel E; Lincoff, A Michael; Moses, Jeffrey W; White, Harvey D; Pocock, Stuart J; Ware, James H; Feit, Frederick; Colombo, Antonio; Aylward, Philip E; Cequier, Angel R; Darius, Harald; Desmet, Walter; Ebrahimi, Ramin; Hamon, Martial; Rasmussen, Lars H; Rupprecht, Hans-Jurgen; Hoekstra, James; Mehran, Roxana; Ohman, E Magnus
2006 Nov 23;355(21):2203-2216, New England journal of medicine
BACKGROUND: Current guidelines for patients with moderate- or high-risk acute coronary syndromes recommend an early invasive approach with concomitant antithrombotic therapy, including aspirin, clopidogrel, unfractionated or low-molecular-weight heparin, and glycoprotein IIb/IIIa inhibitors. We evaluated the role of thrombin-specific anticoagulation with bivalirudin in such patients. METHODS: We assigned 13,819 patients with acute coronary syndromes to one of three antithrombotic regimens: unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudin plus a glycoprotein IIb/IIIa inhibitor, or bivalirudin alone. The primary end points were a composite ischemia end point (death, myocardial infarction, or unplanned revascularization for ischemia), major bleeding, and the net clinical outcome, defined as the combination of composite ischemia or major bleeding. RESULTS: Bivalirudin plus a glycoprotein IIb/IIIa inhibitor, as compared with heparin plus a glycoprotein IIb/IIIa inhibitor, was associated with noninferior 30-day rates of the composite ischemia end point (7.7% and 7.3%, respectively), major bleeding (5.3% and 5.7%), and the net clinical outcome end point (11.8% and 11.7%). Bivalirudin alone, as compared with heparin plus a glycoprotein IIb/IIIa inhibitor, was associated with a noninferior rate of the composite ischemia end point (7.8% and 7.3%, respectively; P=0.32; relative risk, 1.08; 95% confidence interval [CI], 0.93 to 1.24) and significantly reduced rates of major bleeding (3.0% vs. 5.7%; P<0.001; relative risk, 0.53; 95% CI, 0.43 to 0.65) and the net clinical outcome end point (10.1% vs. 11.7%; P=0.02; relative risk, 0.86; 95% CI, 0.77 to 0.97). CONCLUSIONS: In patients with moderate- or high-risk acute coronary syndromes who were undergoing invasive treatment with glycoprotein IIb/IIIa inhibitors, bivalirudin was associated with rates of ischemia and bleeding that were similar to those with heparin. Bivalirudin alone was associated with similar rates of ischemia and significantly lower rates of bleeding. (ClinicalTrials.gov number, NCT00093158 [ClinicalTrials.gov].)
— id: 95982, year: 2006, vol: 355, page: 2203, stat: Journal Article,

Debate of adjunctive pharmacology for percutaneous coronary intervention: thrombin inhibitors and clopidogrel are enough
Yehudai, Loran; Feit, Frederick
2006 Oct;19(5):464-469, Journal of interventional cardiology
The role of adjunctive pharmacology for percutaneous coronary intervention (PCI) has been extensively studied, but controversy remains regarding the optimal regimen. While older studies suggest that glycoprotein IIb/IIIa inhibitors (GPI) should be routinely administered, much of this evidence was collected prior to the era of widespread stenting and thienopyridine use. There is now substantial clinical evidence that bivalirudin monotherapy is the optimal adjunctive pharmacology for the vast majority of patients undergoing elective or urgent percutaneous coronary intervention (PCI), including those presenting with an acute coronary syndrome (ACS). Bivalirudin monotherapy provides similar protection from ischemic complications with a reduced rate of major hemorrhage, resulting in a superior net clinical outcome compared with the use of GPI.
— id: 72726, year: 2006, vol: 19, page: 464, stat: Journal Article,

Bivalirudin versus heparin and glycoprotein IIb/IIIa inhibition among patients with renal impairment undergoing percutaneous coronary intervention (a subanalysis of the REPLACE-2 trial)
Chew, Derek P; Lincoff, A Michael; Gurm, Hitinder; Wolski, Katherine; Cohen, David J; Henry, Tim; Feit, Frederick; Topol, Eric J
2005 Mar 1;95(5):581-585, American journal of cardiology
Among patients who undergo percutaneous coronary intervention, renal impairment is associated with an excessive risk of bleeding and ischemic events. Bivalirudin provides comparable suppression of ischemic events with a decrease in bleeding events compared with heparin and glycoprotein IIb/IIIa inhibition. We examined the relation between adverse events, renal impairment, and antithrombotic therapy within a randomized comparison. The Second Randomized Evaluation in PCI Linking Bivalirudin to Reduced Clinical Events per-protocol study population was assessed. Renal function was defined as calculated creatinine clearance <60 ml/min. Events within the overall study population and within each study arm were assessed. Thirty-day events by renal function were compared by chi-square test and logistic regression. Late mortality was compared by log-rank test. Interaction analyses were performed. Among 5,710 patients, renal impairment was associated with increased ischemic events (hazard ratio 1.45, 95% confidence interval 1.13 to 1.88, p = 0.004), bleeding complications (hazard ratio 1.72, 95% confidence interval 1.06 to 2.80, p = 0.028), and excessive 12-month mortality (hazard ratio 3.85, 95% confidence interval 2.67 to 5.54, p <0.001). Bivalirudin provided suppression of ischemic events that was comparable to heparin and glycoprotein IIb/IIIa inhibition regardless of renal impairment. Fewer bleeding events with bivalirudin were also evident irrespective of renal dysfunction. No interaction between treatment assignment, bleeding or ischemic complications, and renal impairment was observed. The safety and efficacy of bivalirudin compared with heparin and planned glycoprotein IIb/IIIa inhibition in this high-risk group are comparable and consistent with the results of the overall trial
— id: 95986, year: 2005, vol: 95, page: 581, stat: Journal Article,

Use of bivalirudin during percutaneous coronary intervention in patients with diabetes mellitus: an analysis from the randomized evaluation in percutaneous coronary intervention linking angiomax to reduced clinical events (REPLACE)-2 trial
Gurm, Hitinder S; Sarembock, Ian J; Kereiakes, Dean J; Young, John J; Harrington, Robert A; Kleiman, Neal; Feit, Frederick; Wolski, Kathy; Bittl, John A; Wilcox, Robert; Topol, Eric J; Lincoff, A Michael
2005 Jun 21;45(12):1932-1938, Journal of the American College of Cardiology
OBJECTIVES: The objective of this study was to confirm that the efficacy and safety of percutaneous coronary intervention (PCI) in diabetic patients are not compromised by a bivalirudin-based antithrombotic strategy. BACKGROUND: Previous studies have shown a survival benefit with use of platelet glycoprotein (GP) IIb/IIIa inhibitors in diabetic patients undergoing PCI. The Randomized Evaluation in Percutaneous Coronary Intervention Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial showed the non-inferiority of a strategy of bivalirudin with provisional GP IIb/IIIa inhibition compared with routine GP IIb/IIIa inhibition. The relative efficacy of these two strategies in diabetic patients has not been studied. METHODS: We evaluated the diabetic patients enrolled in the REPLACE-2 trial to assess the impact of these antithrombotic strategies on the short- and long-term outcome after PCI. RESULTS: The REPLACE-2 trial enrolled 1,624 diabetic patients and 4,368 non-diabetic patients. Compared with non-diabetic patients, diabetic patients had similar short-term outcome but higher mortality at 1 year (3.06% vs. 1.85%, p = 0.004). There was no difference in short-term or long-term ischemic events among the diabetic patients randomized to the two arms. Specifically, the 1-year mortality rate was non-significantly lower in the bivalirudin arm, suggesting no differential survival impact of the two strategies (2.3% vs. 3.9%). There was less minor bleeding in the bivalirudin arm in diabetic patients (12.6% vs. 24.4%, p < 0.001), whereas no difference was seen in the incidence of major bleeding (3.0% vs. 3.3%, p = 0.69). CONCLUSIONS: Compared with routine GP IIb/IIIa inhibition, the use of bivalirudin with provisional GP IIb/IIIa inhibitors in diabetic patients is associated with no differences in clinical outcomes at 30 days, a trend toward lesser mortality at 1 year, and a reduction in minor bleeding
— id: 95985, year: 2005, vol: 45, page: 1932, stat: Journal Article,

Do women undergoing elective percutaneous intervention (PCI) have similar late outcomes compared to men at all age groups? A REPLACE-2 sustudy
Mori, K; Lansky, AJ; Costa, RA; Mintz, GS; Nikolsky, E; Mehran, R; Dangas, G; Fahy, M; Bittl, JA; Harrington, RA; Kleiman, NS; Feit, F; Lincoff, AM; Stone, GW
2005 OCT 17 ;96(7A):113H-114H, American journal of cardiology
— id: 59299, year: 2005, vol: 96, page: 113H, stat: Journal Article,

Impact of age and choice of procedural antithrombotic regimen on ischemic and hemorrhagic outcomes following percutaneous coronary intervention: Analysis from the REPLACE-2 trial
Nikolsky, E; Stone, GW; Mehran, R; Mori, K; Weinberger, J; Dangas, G; Bittl, J; Harrington, RA; Kleiman, NS; Feit, F; Na, YB; Addo, T; Negoita, M; Cohen, Y; Lincoff, AM
2005 OCT 17 ;96(7A):126H-126H, American journal of cardiology
— id: 59302, year: 2005, vol: 96, page: 126H, stat: Journal Article,

Design and rationale for the targeted intra-renal fenoldopam for avoidance of nephropathy (TIFFANY) trial
Price, MJ; Garcia, L; Davidson, C; McNeil, J; Cohen, MG; Mathur, V; Fearon, WF; Weisz, G; Rogers, C; Madyoon, H; Feit, F; Low, R; Reisman, M; Teirstein, PS
2005 OCT 17 ;96(7A):117H-117H, American journal of cardiology
— id: 59300, year: 2005, vol: 96, page: 117H, stat: Journal Article,

Anemia increases mortality but does not increase ischemic complications during percutaneous coronary invervention
Voeltz MD; Attubato MJ; Feit F; Lincoff AM; Manoukian SV
2005 ;45(3 Suppl 1):31A- abstract #1037-12, Journal of the American College of Cardiology
— id: 56302, year: 2005, vol: 45, page: 31A, stat: Journal Article,

Anemia is associated with increased major bleeding complications and early mortality in patients undergoing percutaneous coronary interventions: implications for choices in antithrombotic therapy
Voeltz MD; Attubato MJ; Feit F; Lincoff AM; Manoukian SV
2005 ;45(3 Suppl 1):31A- abstract #1037-13, Journal of the American College of Cardiology
— id: 56301, year: 2005, vol: 45, page: 31A, stat: Journal Article,

Bivalirudin significantly reduces bleeding while maintaining efficacy compared to either abciximab or eptifibatide in percutaneous coronary intervention: Lessons from REPLACE-2
Voeltz, MD; Lincoff, AM; Feit, F; Manoukian, SV
2005 OCT 25 ;112(17):U801-U802, Circulation
— id: 60210, year: 2005, vol: 112, page: U801, stat: Journal Article,

Anemic patients undergoing percutaneous coronary intervention have a higher mortality even in the absence of major bleeding complications
Voeltz, MD; Lincoff, AM; Feit, F; Rao, SV; Quyyumi, AA; Douglas, JS; Manoukian, SV
2005 OCT 17 ;96(7A):125H-125H, American journal of cardiology
— id: 59301, year: 2005, vol: 96, page: 125H, stat: Journal Article,

Major bleeding and transfusions are associated with increased mortality in elderly patients undergoing percutaneous coronary intervention
Voeltz, MD; Lincoff, M; Feit, F; Manoukian, SV
2005 OCT 25 ;112(17):U675-U675, Circulation
— id: 60208, year: 2005, vol: 112, page: U675, stat: Journal Article,

Major hemorrhage is an independent predictor of 1-year mortality following percutaneous coronary intervention: An analysis from REPLACE-2
Attubato, MJ; Feit, F; Bittl, JA; Chew, D; Lincoff, AM
2004 SEP 30 ;94(6A):39E-40E, American journal of cardiology
— id: 48958, year: 2004, vol: 94, page: 39E, stat: Journal Article,

Comparison of bivalirudin versus heparin during percutaneous coronary intervention (the Randomized Evaluation of PCI Linking Angiomax to Reduced Clinical Events [REPLACE]-1 trial)
Lincoff, A Michael; Bittl, John A; Kleiman, Neal S; Sarembock, Ian J; Jackman, J Daniel; Mehta, Sameer; Tannenbaum, Mark A; Niederman, Alan L; Bachinsky, William B; Tift-Mann, J 3rd; Parker, H Graham; Kereiakes, Dean J; Harrington, Robert A; Feit, Frederick; Maierson, Elizabeth S; Chew, Derek P; Topol, Eric J
2004 May 1;93(9):1092-1096, American journal of cardiology
To assess the efficacy of the direct thrombin inhibitor bivalirudin relative to heparin during contemporary coronary intervention, 1,056 patients who underwent elective or urgent revascularization were randomized in a large-scale pilot study to receive heparin (70 U/kg initial bolus) or bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg/hour infusion during the procedure). All patients received aspirin; pretreatment with clopidogrel was encouraged, and glycoprotein (GP) IIb/IIIa blockade was at the physician's discretion. Stents were placed in 85% of patients; 72% received a GP IIb/IIIa inhibitor, and 56% were pretreated with clopidogrel. Activated clotting times were higher among patients randomized to bivalirudin than among those given heparin before device activation (median 359 vs 293 seconds, p <0.001). The composite efficacy end point of death, myocardial infarction, or repeat revascularization before hospital discharge or within 48 hours occurred in 5.6% and 6.9% of patients in the bivalirudin and heparin groups, respectively (p = 0.40). Major bleeding occurred in 2.1% versus 2.7% of patients randomized to bivalirudin or heparin, respectively (p = 0.52). This trial represents the largest prospective dataset of bivalirudin administered concomitantly with planned GP IIb/IIIa blockade and provides evidence of the safety and efficacy of this combined antithrombotic approach
— id: 95989, year: 2004, vol: 93, page: 1092, stat: Journal Article,

Long-term efficacy of bivalirudin and provisional glycoprotein IIb/IIIa blockade vs heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary revascularization: REPLACE-2 randomized trial
Lincoff, A Michael; Kleiman, Neal S; Kereiakes, Dean J; Feit, Frederick; Bittl, John A; Jackman, J Daniel; Sarembock, Ian J; Cohen, David J; Spriggs, Douglas; Ebrahimi, Ramin; Keren, Gadi; Carr, Jeffrey; Cohen, Eric A; Betriu, Amadeo; Desmet, Walter; Rutsch, Wolfgang; Wilcox, Robert G; de Feyter, Pim J; Vahanian, Alec; Topol, Eric J
2004 Aug 11;292(6):696-703, JAMA
CONTEXT: In the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial, bivalirudin with provisional glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition was found to be noninferior to heparin plus planned Gp IIb/IIIa blockade in the prevention of acute ischemic end points and was associated with significantly less bleeding by 30 days after percutaneous coronary intervention (PCI). OBJECTIVE: To determine whether the efficacy of bivalirudin remains comparable with that of heparin plus Gp IIb/IIIa blockade over 6 months and 1 year. DESIGN, SETTING, AND PARTICIPANTS: Follow-up study to 1 year of a randomized, double-blind trial conducted among 6010 patients undergoing urgent or elective PCI at 233 community or referral hospitals in 9 countries from October 2001 through August 2002. INTERVENTIONS: Patients were randomly assigned to receive intravenously bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg per hour for the duration of PCI), with provisional Gp IIb/IIIa inhibition, or to receive heparin (65 U/kg bolus), with planned Gp IIb/IIIa inhibition (abciximab or eptifibatide). Both groups received daily aspirin and a thienopyridine for at least 30 days after PCI. MAIN OUTCOME MEASURES: Incidence of death, myocardial infarction, or repeat revascularization by 6 months and death by 12 months after enrollment. RESULTS: At 6 months, death occurred in 1.4% of patients in the heparin plus Gp IIb/IIIa group and in 1.0% of patients in the bivalirudin group (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.43-1.14; P =.15). Myocardial infarction occurred in 7.4% and 8.2% of patients, respectively (HR, 1.12; 95% CI, 0.93-1.34; P =.24), and repeat revascularization was required in 11.4% and 12.1% of patients, respectively (HR, 1.06; 95% CI, 0.91-1.23; P =.45). By 1 year, death occurred in 2.46% of patients treated with heparin plus Gp IIb/IIIa blockade and in 1.89% of patients treated with bivalirudin (HR, 0.78; 95% CI, 0.55-1.11; P =.16). Nonsignificant trends toward lower 1-year mortality with bivalirudin were present in all patient subgroups analyzed and were of greatest magnitude among high-risk patients. CONCLUSION: Long-term clinical outcome with bivalirudin and provisional Gp IIb/IIIa blockade is comparable with that of heparin plus planned Gp IIb/IIIa inhibition during contemporary PCI
— id: 95988, year: 2004, vol: 292, page: 696, stat: Journal Article,

Outcomes of patients with acute coronary syndromes who are treated with bivalirudin during P
Rajagopal, V; Lincoff, AM; Cohen, DJ; Gurm, HS; Hu, TF; Desmet, W; Gasthuisberg, UH; Bittl, J; Feit, F; Topol, EJ
2004 OCT 26 ;110(17):340-340, Circulation
— id: 55941, year: 2004, vol: 110, page: 340, stat: Journal Article,

Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) trial: study design and rationale
Stone, Gregg W; Bertrand, Michel; Colombo, Antonio; Dangas, George; Farkouh, Michael E; Feit, Frederick; Lansky, Alexandra J; Lincoff, A Michael; Mehran, Roxana; Moses, Jeffrey W; Ohman, Magnus; White, Harvey D
2004 Nov;148(5):764-775, American heart journal
BACKGROUND: Patients with acute coronary syndromes (ACS; unstable angina and non-ST-segment elevation myocardial infarction) are at significant risk for death and myocardial infarction. Early angiography followed by revascularization is considered the treatment of choice for moderate- to high-risk patients with ACS. However, despite the integration of newer therapies including stents, glycoprotein IIb/IIIa inhibitors, and thienopyridines, the rate of adverse ischemic events still remains unacceptably high, and the intensive pharmacologic regimens used to stabilize the disrupted atherosclerotic plaque and support angioplasty and surgical revascularization procedures elicit a high rate of bleeding complications. Pilot trials suggest that the thrombin-specific anticoagulant bivalirudin may improve clinical outcomes in ACS. STUDY DESIGN: In the Acute Catheterization and Urgent Intervention Triage strategY (ACUITY) trial, 13,800 patients with moderate- to high-risk ACS are being prospectively randomly assigned at up to 600 centers to unfractionated heparin or enoxaparin + IIb/IIIa inhibition, versus bivalirudin + IIb/IIIa inhibition, versus bivalirudin + provisional IIb/IIIa inhibition. All patients undergo cardiac catheterization within 72 hours, followed by percutaneous or surgical revascularization when appropriate. In a second random assignment, patients assigned to receive IIb/IIIa inhibitors are subrandomized to upstream drug initiation, versus IIb/IIIa inhibitor administration during angioplasty only. The primary study end point is the composite of death, myocardial infarction, unplanned revascularization for ischemia, and major bleeding at 30 days. Clinical follow-up will continue for 1 year. CONCLUSIONS: The ACUITY trial is the largest study yet performed in patients with ACS undergoing an invasive strategy. In addition to evaluating the utility of bivalirudin in ACS, this study will also provide important guidance regarding the necessity for and timing of IIb/IIIa inhibitor administration
— id: 95987, year: 2004, vol: 148, page: 764, stat: Journal Article,

Impact of the metabolic syndrome on long-term mortality in patients with multi-vessel coronary artery disease undergoing revascularization
Yatskar, L; Holper, E; Lombardero, M; Schwartzbard, A; Ramanathan, K; Fisher, E; Feit, F
2004 OCT 26 ;110(17):118-118, Circulation
— id: 55937, year: 2004, vol: 110, page: 118, stat: Journal Article,

ACT guided bivalirudin therapy for intracoronary radiation
Attubato M; Pena-Sing IR; Schanzer RJ; Rill VL; El-Omar MM; Friedman L; Zinn AP; Ellerin BE; Hirsch AE; DeWyngaert JK; Lief EP; Keller NM; Feit F
2003 ;59:123-123, Catheterization & cardiovascular interventions
— id: 56299, year: 2003, vol: 59, page: 123, stat: Journal Article,

The effect of femoral artery closure devices on hemorrhagic events in patients receiving bivalirudin or heparin: an observation study from REPLACE-1
Attubato MJ; Feit F; Kleiman NS; Lincoff AM; [The REPLACE-1 Investigators]
2003 ;59:102-102 abstract #A32, Catheterization & cardiovascular interventions
— id: 56298, year: 2003, vol: 59, page: 102, stat: Journal Article,

Bivalirudin reduces hemorrhagic complications and glycoprotein IIB/IIIA inhibitor usage in coronary intervention: Results from the NYU bivalirudin registry
Attubato, MJ; Friedman, L; Zinn, AP; Pena-Sing, IR; Schanzer, RJ; Messina, AJ; Mezzafonte, S; Winer, HE; Feit, F
2003 MAR 19 ;41(6):5A-5A, Journal of the American College of Cardiology
— id: 37100, year: 2003, vol: 41, page: 5A, stat: Journal Article,

Bivalirudin provides increasing benefit with decreasing renal function: a meta-analysis of randomized trials
Chew, Derek P; Bhatt, Deepak L; Kimball, William; Henry, Timothy D; Berger, Peter; McCullough, Peter A; Feit, Frederick; Bittl, John A; Lincoff, A Michael
2003 Oct 15;92(8):919-923, American journal of cardiology
Chronic kidney disease is associated with an increased risk of ischemic and bleeding events after percutaneous coronary intervention (PCI). The direct thrombin inhibitor bivalirudin reduces these combined events. We sought to assess whether this benefit was influenced by renal function. A meta-analysis of 3 randomized trials (n = 5,035) comparing bivalirudin with heparin during PCI, stratified by estimated creatinine clearance using the Cockcroft-Gault equation (>90 [n = 1,578], 90 to 60 [n = 2,163], 59 to 30 [n = 1,255], and <30 ml/min [n = 39]), was conducted. The composite end points of death, myocardial infarction or revascularization, hemorrhage, and combined ischemic or bleeding events were assessed. A common odds ratio for each creatinine clearance strata was estimated with a random-effects model. The interaction between renal impairment and benefit from bivalirudin was assessed. Adverse ischemic and bleeding events increased with decreasing renal function. The relative benefit of bivalirudin with respect to ischemic and bleeding events was maintained within each stratum. The absolute benefit in terms of ischemic and bleeding complications increased with decreasing creatinine clearance (normal 2.2%, mild 5.8%, moderate 7.7%, severe 14.4%; p trend <0.001, interaction p = 0.044). Renal dysfunction remains a prevalent risk factor for ischemic and bleeding events in patients who undergo PCI. Bivalirudin provides greater absolute benefit in patients with impaired renal function
— id: 95990, year: 2003, vol: 92, page: 919, stat: Journal Article,

Bivalirudin reduces ischemic and hemorrhagic complications of percutaneous coronary intervention: Pooled data from 10 prospective studies in 6,134 patients
Feit, F; Bitti, JA; Lincoff, AM; Chew, DP; Kleiman, NS; Wallentin, L; White, HD; Orniston, J; Robson, R; Aylward, PE; Attubato, MJ
2003 MAR 19 ;41(6):25A-25A, Journal of the American College of Cardiology
— id: 37101, year: 2003, vol: 41, page: 25A, stat: Journal Article,

Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial
Lincoff, A Michael; Bittl, John A; Harrington, Robert A; Feit, Frederick; Kleiman, Neal S; Jackman, J Daniel; Sarembock, Ian J; Cohen, David J; Spriggs, Douglas; Ebrahimi, Ramin; Keren, Gadi; Carr, Jeffrey; Cohen, Eric A; Betriu, Amadeo; Desmet, Walter; Kereiakes, Dean J; Rutsch, Wolfgang; Wilcox, Robert G; de Feyter, Pim J; Vahanian, Alec; Topol, Eric J
2003 Feb 19;289(7):853-863, JAMA
CONTEXT: The direct thrombin inhibitor bivalirudin has been associated with better efficacy and less bleeding than heparin during coronary balloon angioplasty but has not been widely tested during contemporary percutaneous coronary intervention (PCI). OBJECTIVE: To determine the efficacy of bivalirudin, with glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition on a provisional basis for complications during PCI, compared with heparin plus planned Gp IIb/IIIa blockade with regard to protection from periprocedural ischemic and hemorrhagic complications. DESIGN, SETTING, AND PARTICIPANTS: The Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial, a randomized, double-blind, active-controlled trial conducted among 6010 patients undergoing urgent or elective PCI at 233 community or referral hospitals in 9 countries from October 2001 through August 2002. INTERVENTIONS: Patients were randomly assigned to receive intravenous bivalirudin (0.75-mg/kg bolus plus 1.75 mg/kg per hour for the duration of PCI), with provisional Gp IIb/IIIa inhibition (n = 2999), or heparin (65-U/kg bolus) with planned Gp IIb/IIIa inhibition (abciximab or eptifibatide) (n = 3011). Both groups received daily aspirin and a thienopyridine for at least 30 days after PCI. MAIN OUTCOME MEASURES: The primary composite end point was 30-day incidence of death, myocardial infarction, urgent repeat revascularization, or in-hospital major bleeding; the secondary composite end point was 30-day incidence of death, myocardial infarction, or urgent repeat revascularization. RESULTS: Provisional Gp IIb/IIIa blockade was administered to 7.2% of patients in the bivalirudin group. By 30 days, the primary composite end point had occurred among 9.2% of patients in the bivalirudin group vs 10.0% of patients in the heparin-plus-Gp IIb/IIIa group (odds ratio, 0.92; 95% confidence interval, 0.77-1.09; P =.32). The secondary composite end point occurred in 7.6% of patients in the bivalirudin vs 7.1% of patients in the heparin-plus-Gp IIb/IIIa groups (odds ratio, 1.09; 95% confidence interval 0.90-1.32; P =.40). Prespecified statistical criteria for noninferiority to heparin plus Gp IIb/IIIa were satisfied for both end points. In-hospital major bleeding rates were significantly reduced by bivalirudin (2.4% vs 4.1%; P<.001). CONCLUSIONS: Bivalirudin with provisional Gp IIb/IIIa blockade is statistically not inferior to heparin plus planned Gp IIb/IIIa blockade during contemporary PCI with regard to suppression of acute ischemic end points and is associated with less bleeding
— id: 37076, year: 2003, vol: 289, page: 853, stat: Journal Article,

The impact of access site hematoma with transfusion in patients undergoing percutaneous coronary intervention: A report from the NHLBI dynamic registry
Slater, J; Selzer, F; Feit, F; Cohen, HA; Jacobs, AK; Williams, DO
2003 SEP 15 ;92(6A):18L-18L, American journal of cardiology
— id: 38554, year: 2003, vol: 92, page: 18L, stat: Journal Article,

The impact of adverse access site hematoma in patients undergoing percutaneous coronary intervention: A report from the NHLBI dynamic registry
Slater, J; Selzer, F; Feit, F; Cohen, HA; Jacobs, AK; Williams, DO
2003 OCT 28 ;108(17):356-356, Circulation
— id: 42564, year: 2003, vol: 108, page: 356, stat: Journal Article,

Detection of abdominal aortic aneurysms during cardiac catheterization
Attubato, M; Simon, DB; Levite, HA; Winer, HE; Keller, NM; Feit, F
2002 SEP 24 ;90(6A):127H-128H, American journal of cardiology
— id: 55582, year: 2002, vol: 90, page: 127H, stat: Journal Article,

Clopidogrel plus aspirin was effective but increased bleeding in acute coronary syndromes without ST-segment elevation
Kronzon, Ithak; Feit, Frederick
2002 Mar-Apr;136(2):45-45, ACP journal club
— id: 27279, year: 2002, vol: 136, page: 45, stat: Journal Article,

Survival following coronary angioplasty versus coronary artery bypass surgery in anatomic subsets in which coronary artery bypass surgery improves survival compared with medical therapy. Results from the Bypass Angioplasty Revascularization Investigation (BARI)
Berger PB; Velianou JL; Aslanidou Vlachos H; Feit F; Jacobs AK; Faxon DP; Attubato M; Keller N; Stadius ML; Weiner BH; Williams DO; Detre KM
2001 Nov 1;38(5):1440-1449, Journal of the American College of Cardiology
OBJECTIVES: We sought to compare survival after coronary artery bypass graft (CABG) and percutaneous transluminal coronary angioplasty (PTCA) in high-risk anatomic subsets. BACKGROUND: Compared with medical therapy, CABG decreases mortality in patients with three-vessel disease and two-vessel disease involving the proximal left anterior descending artery (LAD), particularly if left ventricular (LV) dysfunction is present. How survival after PTCA and CABG compares in these high-risk anatomic subsets is unknown. METHODS: In the Bypass Angioplasty Revascularization Investigation (BARI), 1,829 patients with multivessel disease were randomized to an initial strategy of PTCA or CABG between 1988 and 1991. Stents and IIb/IIIa inhibitors were not utilized. Since patients in BARI with diabetes mellitus had greater survival with CABG, separate analyses of patients without diabetes were performed. RESULTS: Seven-year survival among patients with three-vessel disease undergoing PTCA and CABG (n = 754) was 79% versus 84% (p = 0.06), respectively, and 85% versus 87% (p = 0.36) when only non-diabetics (n = 592) were analyzed. In patients with three-vessel disease and reduced LV function (ejection fraction <50%), seven-year survival was 70% versus 74% (p = 0.6) in all PTCA and CABG patients (n = 176), and 82% versus 73% (p = 0.29) among non-diabetic patients (n = 124). Seven-year survival was 87% versus 84% (p = 0.9) in all PTCA and CABG patients (including diabetics) with two-vessel disease involving the proximal LAD (n = 352), and 78% versus 71% (p = 0.7) in patients with two-vessel disease involving the proximal LAD with reduced LV function (n = 72). CONCLUSION: In high-risk anatomic subsets in which survival is prolonged by CABG versus medical therapy, revascularization by PTCA and CABG yielded equivalent survival over seven years
— id: 37078, year: 2001, vol: 38, page: 1440, stat: Journal Article,

Bivalirudin versus heparin during coronary angioplasty for unstable or postinfarction angina: Final report reanalysis of the Bivalirudin Angioplasty Study
Bittl JA; Chaitman BR; Feit F; Kimball W; Topol EJ
2001 Dec;142(6):952-959, American heart journal
BACKGROUND: This study was a reanalysis of the Bivalirudin Angioplasty Study, which compared bivalirudin with high-dose heparin during coronary angioplasty for unstable angina. METHODS: Differences in rates of death, myocardial infarction, or repeat revascularization were compared at 7, 90, and 180 days after angioplasty with intention-to-treat analysis. RESULTS: The combined end point occurred in 135 of 2161 patients (6.2%) in the bivalirudin group and in 169 of 2151 patients (7.9%) in the heparin group at 7 days (P =.039). Differences persisted between the groups at 90 days (P =.012) and 180 days (P =.153). Bleeding occurred in 76 patients (3.5%) in the bivalirudin group versus 199 (9.3%) in the heparin group (P <.001). CONCLUSIONS: This analysis supports the hypothesis that bivalirudin reduces ischemic complications and bleeding after angioplasty. Further trials are needed to evaluate bivalirudin versus heparin in conjunction with platelet-glycoprotein IIb/IIIa inhibitors and for coronary stenting
— id: 37077, year: 2001, vol: 142, page: 952, stat: Journal Article,

Directional coronary atherectomy in intermediate sized vessels: final results of the intermediate vessel atherectomy trial (IVAT)
Cannon L; Senior D; Feit F; Attubato MJ; Rosenberg J; O'Donnell MJ; Hirst J; Gibson M
2000 Apr;49(4):396-400, Catheterization & cardiovascular interventions
Revascularization options for intermediate sized vessels (2.5-2.9 mm) have historically been limited. IVAT is a pilot study to assess the efficacy and safety of debulking intermediate sized vessels using directional coronary atherectomy (DCA). Between March 1996 and June 1997, 50 patients were enrolled at seven hospitals in the United States. Of those patients, 70% presented with unstable angina and 52% had single vessel disease. Of the lesions treated, 96% were de novo. Adjunctive PTCA after DCA was performed in 90% of cases at the discretion of the investigator to maximize luminal diameter. The GTO DCA device was used in 90% of cases. Procedural success (residual stenosis <50% without major complications) was 94%. Stents were placed in 12% of patients. The only complications were three non-Q wave MIs. Mean reference vessel diameter increased from 2.49 mm pre-procedure to 2.57 mm after DCA and 2.61 post-procedure; mean MLD increased from 0.76 mm to 2.03 mm to 2.31 mm; and mean stenosis decreased from 70% to 21% post DCA and to 11% post procedure. At six months follow-up, 18.0% of target lesions required revascularization. Total revascularization, including non-target vessels, was 32%. These results suggest that DCA has a high procedural success rate and a low target lesion revascularization rate in intermediate sized vessels
— id: 37079, year: 2000, vol: 49, page: 396, stat: Journal Article,

Percutaneous coronary artery intervention: the last five years and the next five years
Feit F
2000 Feb;139(2 Pt 1):195-197, American heart journal
— id: 8548, year: 2000, vol: 139, page: 195, stat: Journal Article,

Hemorrhagic complications in association with percutaneous coronary intervention: can the risk be attenuated?
Feit F; Bittl JA; Keller NM; Attubato MJ; Weitz JI
2000 Dec;12 Suppl F(1):7F-13, Journal of invasive cardiology
— id: 36055, year: 2000, vol: 12 Suppl F, page: 7F, stat: Journal Article,

Long-term clinical outcome in the Bypass Angioplasty Revascularization Investigation Registry: comparison with the randomized trial. BARI Investigators
Feit F; Brooks MM; Sopko G; Keller NM; Rosen A; Krone R; Berger PB; Shemin R; Attubato MJ; Williams DO; Frye R; Detre KM
2000 Jun 20;101(24):2795-2802, Circulation
BACKGROUND: The Bypass Angioplasty Revascularization Investigation (BARI) included 4039 patients with multivessel coronary artery disease; 1829 consented to randomization, and 2010 did not but were followed up in a registry. Thus, we can evaluate the outcome of physician-guided versus random assignment of percutaneous transluminal coronary angioplasty (PTCA) versus coronary artery bypass graft surgery (CABG). METHODS AND RESULTS: We compared the baseline features and outcomes for PTCA and CABG in the overall registry and its predesignated subgroups. We assessed the impact of treatment by choice versus random assignment by comparing the results in the registry with those of the randomized trial. Statistical adjustments for differences in baseline characteristics were made. Within the registry, nearly twice as many patients were selected for PTCA (1189) as CABG (625); mortality at 7 years was similar for PTCA (13.9%) and CABG (14.2%) (P=0.66) before and after adjustment for baseline differences between patients selected for PTCA versus CABG (adjusted RR, 1.02; P=0.86). In contrast to the randomized trial, the 7-year mortality rate of treated diabetics in the registry was equally high (26%) with PTCA or CABG. Seven-year mortality was higher for patients undergoing PTCA in the randomized trial than in the registry (19.1% versus 13.9%, P<0.01) but not for those undergoing CABG (15.6% versus 14.2%, P=0.57). The adjusted relative mortality risk for PTCA in the randomized versus registry population was 1.17 (P=0.16). CONCLUSIONS: BARI physicians were able to select PTCA rather than CABG for 65% of registry patients who underwent revascularization without compromising long-term survival either in the overall population or in treated diabetics
— id: 36056, year: 2000, vol: 101, page: 2795, stat: Journal Article,

The first clinical trial comparing a coated versus a non-coated coronary stent: The biocompatibles BiodivYsio (TM) stent in randomized control trial (distinct)
Moses, JW; Buller, CEH; Nukta, ED; Aluka, AO; Farhat, N; Barbeau, GR; Popma, JJ; Moussa, I; New, GS; Feit, F
2000 OCT 31 ;102(18):664-+, Circulation
— id: 55250, year: 2000, vol: 102, page: 664, stat: Journal Article,

Novel dosing regimen of eptifibatide in planned coronary stent implantation (ESPRIT): a randomised, placebo-controlled trial
Tcheng, JE; O'Shea, JC; Cohen, EA; Pacchiana, CM; Kitt, MM; Lorenz, TJ; Greenberg, S; Strony, J; Califf, RM; Buller, C; Cantor, WJ; Joseph, DM; Kitt, MM; Lincoff, AM; Madan, M; Popma, J; Teirstein, P; Cohen, E; Balleza, L; Parsons, P; Lui, H; Young, J; Fox, R; Labinaz, M; Jelley, J; Williams, J; Cohen, D; Trovato, M; Smith, J; Henry, P; Chisholm, R; O'Donnell, D; Talley, JD; Pacheco, R; Timmis, S; Muraka, A; Mann, T; Cubeddu, G; Tannenbaum, M; Greene, J; Santoian, E; Wash, M; Sheldon, S; Pronesti, L; Jain, A; Alonzo, M; Seidelin, P; Richards, J; Lopez, M; Dittenber, R; Johnson, K; Levine, G; Maresh, K; Ferrando, T; Sarembock, I; Snyder, L; Kieval, J; Herlan, L; Miller, M; Bembridge, D; Nair, R; Hickel, L; Kiernan, F; Murphy, D; Cloutier, J; Conn, E; Beardsley, J; Ritchie, M; Cragen, D; Jafar, MZ; Counihan, P; Rosenfelder, D; Ducas, J; Montebruno, L; Carere, R; Radons, B; Williams, L; Owens, W; Dougal, R; Feldman, R; Audrain, D; Karamali, A; Smith, M; Blankenship, J; Demko, SL; Thompson, M; Gacoich, G; Chiodo, V; Noll, P; Ledley, G; Miller, C; Felten, W; Garner, B; Chandler, AB; Easler, P; Albin, G; Page, A; Maddox, W; Allen, S; Gilchrist, I; Moore, R; Zimmerman, H; Curtis, M; Hildebrand, K; Greene, R; Healy, E; Meengs, W; Carson, D; George, J; Roncevich, T; Aharonian, V; Browning, R; Kostuk, W; Carr, S; Feit, F; Gostomsky, B; Butman, S; Hannah, E; Hassel, CD; Hartley, D; Shook, T; Hiller-Mullin, S; Brill, D; Dillion, M; Armstrong, B; Kerns, D; Pichard, A; Okubagzi, P; Nasser, T; Driver, L; Garrett, J; Boltey, L; Stouffer, G; Potter, M; Amidon, T; Eggert, S; Taussig, A; Potter, K; Natarajan, M; Tartaglia, C; Werner, J; Dunlap, T; Harrold-Runge, P; Davidson, C; Goodreau, L; Herzog, W; Calamunci, N; Slater, A; Tormey, D; Phillips, W; White, D; Sridhar, K; White, J; Goodman, D; Buchbinder, M; Nasser, V; Rapeport, K; Vorman, P; Weiner, B; Borbone, M; Shadoff, N; Paap, C; Rehman, A; Haag, E; Burchenal, J; Kioussopoulos, K; Senior, D; Senior, J; Piana, R; Kirshenbaum, J; Chan, S; Chowdry, A; Kraft, P; Clark, V; Fox, M; Deutsch, E; Shannon, T; Quesada, R; Brotherton, J; Murrin, C; Cinderella, J; Hearne, S; Seefried, V; Farah, T; Pakstis, D; Bartolet, B; Bond, C; Debarardinis, C; Montory, D; Smith, G; Gray, D; Phillips, P; Hathaway, S; Manoukian, S; Patrick, C; Yakubov, S; Brooks, J; Block, P; Block, B; Muhlestein, JB; Kim, S; Shalev, Y; Schmidt, W; Resar, J; Citro, K; Stine, R; Zumbuhl, J; Moreyra, A; Kreiger, S; Berger, P; Cannon, CP; Fisher, L; Hasselblad, V; Foster, A; Joseph, D; Madan, M; McLendon, C; Rund, M; Tillery, N; Wood, F; Mahaffey, KW; Irwin, C; Kulick, D; Johnson, N; Chen, J; Greenberg, S; Hogeboom, C; Lorenz, TJ; Terifay, R; Strony, J; Veltri, E
2000 DEC 16 ;356(9247):2037-2044, Lancet
Background The platelet glycoprotein IIb/IIIa inhibitors, although effective in reducing ischaemic complications of percutaneous coronary intervention. are used in few coronary stent implantation procedures. ESPRIT (Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy) is a randomised, placebo-controlled trial to assess whether a novel, double-bolus dose of eptifibatide could improve outcomes of patients undergoing coronary stenting. Methods We recruited 2064 patients undergoing stent implantation in a native coronary artery. Immediately before percutaneous coronary intervention, patients were randomly allocated to receive eptifibatide, given as two 180 mug/kg boluses 10 min apart and a continuous infusion of 2.0 mug/kg/min for 18-24 h, or placebo, in addition to aspirin, heparin, and a thienopyridine. The primary endpoint was the composite of death, myocardial infarction, urgent target vessel revascularisation, and thrombotic bailout glycoprotein IIb/IIIa inhibitor therapy within 48 h after randomisation. The key secondary endpoint was the composite of death, myocardial infarction, or urgent target vessel revascularisation at 30 days. Findings The trial was terminated early for efficacy. The primary endpoint was reduced from 10.5% (108 of 1024 patients on placebo [95% CI 8.7-12.4%]) to 6.6% (69 of 1040 [5.1-8.1%]) with treatment (p=0.0015). The key 30 day secondary endpoint was also reduced, from 10.5% (107 of 1024 patients on placebo [8.6-12.3%]) to 6.8% (71 of 1040 [5.3-8.4%]; p=0.0034). There was consistency in reduction of events across all components of the composite endpoint and among the major subgroups. Major bleeding was infrequent but arose more often with eptifibatide than placebo (1.3%, 13 of 1040 [0.7-2.1%]) vs 0.4%, 4 of 1024 [0.1-1.0%]; p=0.027). Interpretation Routine glycoprotein IIb/IIIa inhibitor pretreatment with eptifibatide substantially reduces ischaemic complications in coronary stent intervention and is better than a strategy of reserving treatment to the bailout situation
— id: 55267, year: 2000, vol: 356, page: 2037, stat: Journal Article,

Coronary revascularization in diabetic patients: a comparison of the randomized and observational components of the Aypass Angioplasty Revascularization Investigation (BARI)
Detre KM; Guo P; Holubkov R; Califf RM; Sopko G; Bach R; Brooks MM; Bourassa MG; Shemin RJ; Rosen AD; Krone RJ; Frye RL; Feit F
1999 Feb 9;99(5):633-640, Circulation
BACKGROUND: Patients with treated diabetes in the randomized-trial segment of the Bypass Angioplasty Revascularization Investigation (BARI) who were randomized to initial revascularization with PTCA had significantly worse 5-year survival than patients assigned to CABG. This treatment difference was not seen among diabetic patients eligible for BARI who opted to select their mode of revascularization. We hypothesized that differences in patient characteristics, assessed and unmeasured, together with the treatment selection in the registry, at least partially account for this discrepancy. METHODS AND RESULTS: Among diabetics taking insulin or oral hypoglycemic drugs at entry, angiographic and clinical presentations were comparable between randomized and registry patients. However, more registry patients were white, and registry diabetics tended to be more educated and more physically active and to report better quality of life. Procedural characteristics and in-hospital complications were comparable. The 5-year all-cause mortality rate was 34.5% in randomized diabetic patients assigned to PTCA versus 19.4% in CABG patients (P=0.0024; relative risk [RR]=1.87); corresponding cardiac mortality rates were 23.4% and 8.2%, respectively (P=0.0002; RR=3.10). The CABG benefit was more apparent among patients requiring insulin. In the registry, all-cause mortality was 14.4% for PTCA versus 14.9% for CABG (P=0.86, RR=1.10), with corresponding cardiac mortality rates of 7.5% and 6. 0%, respectively (P=0.73; RR=1.07). These RRs in the registry increased to 1.29 and 1.41, respectively, after adjustment for all known differences between treatment groups. CONCLUSIONS: BARI registry results are not inconsistent with the finding in the randomized trial that initial CABG is associated with better long-term survival than PTCA in treated diabetic patients with multivessel coronary disease suitable for either surgical or catheter-based revascularization
— id: 57353, year: 1999, vol: 99, page: 633, stat: Journal Article,

Thrombolytic therapy in acute MI, Part 1: New approaches
Keller NM; Feit F
1999 ;13(9):541-555, Journal of critical illness
Thrombolytic therapy is lifesaving in patients with acute myocardial infarction who present within 12 hours of symptom onset, have ECG signs of ST-segment elevation or new left bundle branch block, and have no contraindications to thrombolysis (such as internal bleeding, recent major surgery or trauma, intracranial disease, or severe uncontrolled hypertension). Certain patients presenting more than 12 hours after symptom onset also may be candidates for thrombolysis. However, only 54% of patients obtain normal angiographic blood flow with the most aggressive regimen validated to date: accelerated recombinant tissue type plasminogen activator plus aspirin and heparin. Newer and investigational drugs, such as reteplase, lanoteplase, and saruplase, are easier to administer but generally have not yet been shown to be safer or more effective than other thrombolytics
— id: 15959, year: 1999, vol: 13, page: 541, stat: Journal Article,

Thrombolytic therapy in acute MI, part 2: Update on adjuvants
Keller NM; Feit F
1999 ;13(10):646-652, Journal of critical illness
Direct percutaneous transluminal coronary angioplasty has recently shown better results than thrombolysis in reestablishing normal arterial flow following an acute myocardial infarction (MI). Because many patients do not have timely access to well-established cardiac catheterization facilities, however, optimizing the use of thrombolytic agents, as well as adjuvant therapies that inhibit the prothrombotic process, remains an essential strategy. Prescribe chewed aspirin for all patients with acute MI; also give heparin with recombinant tissue-type plasminogen activator and pharmacologically similar thrombolytics. Low molecular weight heparin is easier to use than the unfractionated drug may reduce the risk of reinfarction. Newer and investigational antiplatelet and antithrombin agents (such as abciximab and bivalirudin) have yielded evidence of improved arterial patency with fewer hemorrhagic complications
— id: 15958, year: 1999, vol: 13, page: 646, stat: Journal Article,

Influence of pre-PTCA strategy and initial PTCA result in patients with multivessel disease: the Bypass Angioplasty Revascularization Investigation (BARI)
Kip KE; Bourassa MG; Jacobs AK; Schwartz L; Feit F; Alderman EL; Weiner BH; Weiss MB; Kellett MA Jr; Sharaf BL; Dimas AP; Jones RH; Sopko G; Detre KM
1999 Aug 31;100(9):910-917, Circulation
BACKGROUND: In PTCA patients with multivessel coronary artery disease, incomplete revascularization (IR) is the result of both pre-PTCA strategy and initial lesion outcome. The unique contribution of these components on long-term patient outcome is uncertain. METHODS AND RESULTS: From the Bypass Angioplasty Revascularization Investigation (BARI), 2047 patients who underwent first-time PTCA were evaluated. Before enrollment, all significant lesions were assessed by the PTCA operator for clinical importance and intention to dilate. Complete revascularization (CR) was defined as successful dilatation of all clinically relevant lesions. Planned CR was indicated in 65% of all patients. More lesions were intended for PTCA in these patients compared with those with planned IR (2.8 versus 2.1). Successful dilatation of all intended lesions occurred in 45% of patients with planned CR versus 56% with planned IR (P<0. 001). In multivariable analysis, planned IR (versus planned CR), initial lesions attempted (not all versus all intended lesions attempted), and initial lesion outcome (not all versus all attempted lesions successful) were unrelated to 5-year risk of cardiac death or death/myocardial infarction but were all independently related to risk of CABG. CONCLUSIONS: Overall, a pre-PTCA strategy of IR in BARI-like patients appears comparable to a strategy of CR except for a higher need for CABG. Whether the use of new devices may attenuate the elevated risk of CABG in patients with multivessel disease and planned IR remains to be determined
— id: 37080, year: 1999, vol: 100, page: 910, stat: Journal Article,

Does angioplasty prolong survival in patients with multivessel disease? Results from the bypass angioplasty revascularization investigation (BARI)
Velianou, JL; Jacobs, AK; Feit, F; Attubato, M; Vlachos, HA; Detre, KM; Williams, DO; Berger, PB
1999 NOV 2 ;100(18):84-84, Circulation
— id: 53787, year: 1999, vol: 100, page: 84, stat: Journal Article,

A randomized comparison of bivalirudin and heparin in patients undergoing coronary angioplasty for postinfarction angina. Hirulog Angioplasty Study Investigators
Bittl JA; Feit F
1998 Oct 22;82(8B):43P-49P, American journal of cardiology
The outcome of coronary angioplasty performed for unstable angina is determined, in part, by the acuteness and severity of the clinical presentation. The risk of abrupt vessel closure is increased in patients with postinfarction angina. The Hirulog Angioplasty Study compared the efficacy and safety of bivalirudin with weight-adjusted heparin in patients undergoing percutaneous transluminal coronary angioplasty (PTCA) for unstable or postinfarction angina. We report the results of the intent-to-treat analysis using adjudicated data for the prespecified group of 741 patients who underwent angioplasty within 2 weeks of documented myocardial infarction. Patients received either bivalirudin or heparin immediately before angioplasty. The primary efficacy endpoint was procedural failure defined as abrupt vessel closure, death, myocardial infarction, or revascularization during hospitalization. Bivalirudin significantly (p = 0.004) decreased the incidence of procedural failure compared with heparin (5.1% vs 10.8%, odds ratio 0.45; 95% CI 0.25-0.79). The improved efficacy of bivalirudin was replicated for each individual clinical endpoint. The incidence of major bleeding was significantly (p = 0.001) lower in bivalirudin-treated patients compared with heparin-treated patients (2.4% vs 11.8%, respectively). The benefits observed with bivalirudin are of similar magnitude as those reported for platelet glycoprotein (GP) IIb/IIIa inhibitors, such as abciximab. Bivalirudin may be a more effective foundation anticoagulant than heparin in patients undergoing coronary angioplasty for postinfarction angina
— id: 37081, year: 1998, vol: 82, page: 43P, stat: Journal Article,

A randomized comparison of bivalirudin and heparin in patients undergoing coronary angioplasty for post-infarction angina
Feit, F; Bittl, JA
1998 OCT 27 ;98(17):443-443, Circulation
— id: 53666, year: 1998, vol: 98, page: 443, stat: Journal Article,

Predictors of in-hospital events after percutaneous coronary intervention
Feit, F; Weitz, S; Cascade, E; Karweit, J; Schwartz, L
1998 OCT ;82(7A):30S-30S, American journal of cardiology
— id: 53692, year: 1998, vol: 82, page: 30S, stat: Journal Article,

Three dimensional ultrasonic imaging of femoral arterial pseudoaneurysms
Applebaum, RM; Kronzon, I; Attubato, MJ; Feit, F
1997 FEB ;29(2):9450-9450, Journal of the American College of Cardiology
— id: 53294, year: 1997, vol: 29, page: 9450, stat: Journal Article,

Coronary artery disease in the geriatric population
Keller NM; Feit F
1996 Mar-Apr;38(5):407-418, Progress in cardiovascular diseases
The elderly represent an increasingly important and challenging subset of the population of patients with ischemic heart disease. They are more likely to have comorbid conditions, atypical presentations, and unfavorable outcomes than their younger counterparts. Some of these findings are undoubtedly related to the structural and functional changes in the cardiovascular system associated with aging. The available data suggest that standard pharmacologic, thrombolytic, and definitive revascularization techniques have important roles in the therapy of geriatric patients but have been underused
— id: 57365, year: 1996, vol: 38, page: 407, stat: Journal Article,

Atherosclerotic heart disease in the elderly
Keller NM; Feit F
1995 Jul;10(4):427-433, Current opinion in cardiology
The elderly represent an increasingly important and challenging subset of the population of patients with ischemic heart disease. They are more likely to have comorbid conditions, atypical presentations, and unfavorable outcomes. Some of these features are undoubtedly related to the structural and functional changes in the cardiovascular system associated with aging. The available data suggest that standard pharmacologic, thrombolytic, and definitive revascularization techniques have important roles in the treatment of these patients, but have been underused
— id: 12759, year: 1995, vol: 10, page: 427, stat: Journal Article,

Clinical features and pathogenesis of intracerebral hemorrhage after rt-PA and heparin therapy for acute myocardial infarction: the Thrombolysis in Myocardial Infarction (TIMI) II Pilot and Randomized Clinical Trial combined experience
Sloan MA; Price TR; Petito CK; Randall AM; Solomon RE; Terrin ML; Gore J; Collen D; Kleiman N; Feit F; et al.
1995 Apr;45(4):649-658, Neurology
Parenchymatous intracerebral hemorrhage (ICH) is a serious, infrequent complication of thrombolytic therapy for acute myocardial infarction. We studied the clinical and radiologic features, manner of presentation, associated factors, and temporal course in 23 patients with ICH associated with 150 mg or 100 mg recombinant tissue-type plasminogen activator (rt-PA) and heparin therapy for acute myocardial infarction in the Thrombolysis in Myocardial Infarction (TIMI) II Pilot and Randomized Clinical Trial. In TIMI II, 13 of the 23 ICH patients developed or maintained systolic blood pressure > or = 160 mm Hg or diastolic blood pressure > or = 90 mm Hg during the rt-PA infusion and before the onset of neurologic symptoms. Six patients (26%) had life-threatening ventricular arrhythmias, five before onset of neurologic symptoms. A decreased level of consciousness was the earliest neurologic abnormality in 15 (65%) and the most common initial physical finding (in 19, or 82%). Onset was usually gradual (70%), but time to maximal deficit was frequently (61%) within 6 hours of onset. The locations of the primary ICH sites were lobar in 16 (70%), thalamic in four (17%), and brainstem-cerebellum in three (13%), but the putamen was never the primary site. Multiple lobar hemorrhages occurred in six cases (26%). The timing and size of ICH was similar among patients treated with 150 mg rt-PA and 100 mg rt-PA. Brain CT demonstrated an arteriovenous malformation in one case. Four patients had hypofibrinogenemia, which was profound in three patients. Pathologic findings were available for five patients. Of these, three patients had cerebral amyloid angiopathy, and one had hemorrhagic transformation of an ischemic cerebral infarction found at autopsy. We conclude that ICH following rt-PA and heparin therapy for acute myocardial infarction presents as a distinctive clinical syndrome. Intracerebral bleeding after combined thrombolytic and antithrombotic therapy may be associated with cerebral amyloid angiopathy and other vascular lesions. Acute or persistent hypertension before or during rt-PA infusion, life-threatening ventricular arrhythmias, and hypofibrinogenemia, either alone or in combination, may play roles in some cases. Care should be exercised when considering thrombolytic therapy for patients with risk factors for ICH
— id: 37082, year: 1995, vol: 45, page: 649, stat: Journal Article,

Coronary anatomic and procedural characteristics of patients randomized to coronary angioplasty in the Bypass Angioplasty Revascularization Investigation (BARI)
Williams DO; Baim DS; Bates E; Bonan R; Bost JE; Cowley M; Faxon DP; Feit F; Jones R; Kellett MA Jr; et al.
1995 Mar 23;75(9):27C-33C, American journal of cardiology
The Bypass Angioplasty Revascularization Investigation (BARI) is a randomized multicenter clinical trial that compares a strategy of initial coronary angioplasty to initial coronary bypass surgery for patients with multivessel coronary artery disease. The purpose of this report is to describe the coronary anatomic characteristics of the 915 patients assigned to the angioplasty arm of the trial and the manner in which angioplasty was performed. Patients were eligible for BARI if they demonstrated multivessel coronary artery disease, had a clinical indication for revascularization, and were suitable for both coronary angioplasty and bypass surgery. Clinical and technical features of angioplasty procedures were systemically recorded. Coronary cineangiograms obtained before and during the angioplasty were interpreted by a central radiographic laboratory. Angioplasty was performed in 904 (98.8%) of the 915 patients assigned to that initial strategy. Of 6,530 coronary arterial lesions identified, 3,427 (52.5%) were significant (> 50% diameter reduction). The majority of patients had 2-6 significant lesions, with 3 being most common. Angioplasty was attempted in 92.2% of the lesions for which it was intended. Lesions most frequently attempted ranged between 50% and 79% in severity. Multilesion angioplasty was performed in 77.5% of patients and 69.7% had multivessel angioplasty. Factors that influenced whether a lesion was attempted included lesion severity, clinical significance, and complexity. For lesions presenting as total occlusions, a history of recent infarction and postinfarction angina favored attempting angioplasty. Patients assigned to the angioplasty arm of BARI had evidence of extensive multilesion and multivessel coronary artery disease.(ABSTRACT TRUNCATED AT 250 WORDS)
— id: 37083, year: 1995, vol: 75, page: 27C, stat: Journal Article,

Venous changes occurring during the Valsalva maneuver: evaluation by intravascular ultrasound
Attubato MJ; Katz ES; Feit F; Bernstein N; Schwartzman D; Kronzon I
1994 Aug 15;74(4):408-410, American journal of cardiology
— id: 12917, year: 1994, vol: 74, page: 408, stat: Journal Article,

Acute myocardial infarction
Galloway AC; Feit F; Eiseman B
Surgical decision making Philadelphia : Saunders, 1993,
— id: 3816, year: 1993, vol: , page: ?, stat: Chapter,

VENOUS CHANGES OCCURRING DURING THE VALSALVA MANEUVER - AN INTRAVASCULAR ULTRASOUND STUDY
ATTUBATO, MJ; KATZ, ES; FEIT, F; BERNSTEIN, N; SCHWARTZMAN, D; KRONZON, I
1992 OCT ;86(4):871-871, Circulation
— id: 51837, year: 1992, vol: 86, page: 871, stat: Journal Article,

Coronary angioplasty performed within the thrombolysis in Myocardial Infarction II study
Baim DS; Diver DJ; Feit F; Greenberg MA; Holmes DR; Weiner BH; Williams DO; Schweiger MJ; Brown BG; Frederick MM; et al.
1992 Jan;85(1):93-105, Circulation
BACKGROUND. Percutaneous transluminal coronary angioplasty (PTCA) of the infarct-related artery was performed within 42 days of recombinant tissue-type plasminogen activator (rt-PA) administration in 1,414 of the 3,534 patients who participated in the Thrombolysis In Myocardial Infarction (TIMI) II study. Primary angiographic success was obtained in 88.7%, with bypass surgery within 24 hours in 3.3% and death within 24 hours in 0.7% of patients. By 1 year, 25.1% of the 1,414 patients had sustained one or more adverse outcomes including death (3.6%), reinfarction (8.4%), or the need for further revascularization (20%). METHODS AND RESULTS. Despite these generally favorable results, multivariate testing identified several anatomic and clinical subgroups as having an increased risk ratio (RR) for adverse outcome: Unsuccessful PTCA was more common in patients undergoing protocol-assigned PTCA within 2 hours of rt-PA administration (RR, 2.7; p less than 0.001) and in patients over age 70 years (RR, 1.7; p = 0.034). The need for further revascularization within 1 year was increased in the 30.4% of patients with multivessel disease (RR, 2.5; p less than 0.001), patients with prior angina (RR, 1.4; p less than 0.006), or those undergoing ischemia-driven PTCA within 15 hours of rt-PA administration (RR, 1.7; p = 0.022). The risk of death or recurrent infarction within 1 year was increased by the presence of multivessel disease (RR, 1.6; p = 0.007) or prior angina (RR, 1.5; p = 0.014). CONCLUSIONS. These observations do not necessarily apply to patients undergoing primary PTCA (or PTCA after other thrombolytic agents); however, they do offer a unique yardstick against which to evaluate the results of PTCA in myocardial infarction
— id: 37085, year: 1992, vol: 85, page: 93, stat: Journal Article,

Predictors of early morbidity and mortality after thrombolytic therapy of acute myocardial infarction. Analyses of patient subgroups in the Thrombolysis in Myocardial Infarction (TIMI) trial, phase II
Mueller HS; Cohen LS; Braunwald E; Forman S; Feit F; Ross A; Schweiger M; Cabin H; Davison R; Miller D; et al.
1992 Apr;85(4):1254-1264, Circulation
BACKGROUND. Thrombolysis has altered treatment of acute myocardial infarction (AMI). Therefore, reevaluation of predictors of outcome and treatment strategies is appropriate. METHODS AND RESULTS. Clinical variables collected prospectively for the 3,339 patients of the Thrombolysis in Myocardial Infarction II study were analyzed retrospectively to identify predictors of clinical events at 42 days and earlier and to identify subgroups in which an invasive or conservative strategy might be superior. Pulmonary edema/cardiogenic shock presented as the strongest independent correlate with death (relative risk, 6.0). In two subgroups, mortality differed between the invasive and conservative strategies: 1) Patients with versus without prior AMI had a higher mortality in the conservative strategy (11.5% versus 3.5%, p less than 0.001); in the invasive strategy, the mortality rates were similar (6.0% and 5.1%). 2) Patients with diabetes mellitus and no prior AMI had a higher mortality in the invasive than in the conservative strategy (14.8% versus 4.2%, p less than 0.001). Reinfarction was not independently correlated with baseline characteristics except with history of angina (relative risk, 1.9). Mortality was lower in current smokers and ex-smokers versus never-smokers (3.6% and 4.8% versus 8.0%, p less than 0.001). Current smokers had a lower risk profile (p less than 0.001), including age, pulmonary edema/cardiogenic shock, history of hypertension, and diabetes. The rate of reinfarction was lower in current smokers versus ex-smokers and never-smokers (4.6% versus 8.3% and 8.8%, p less than 0.001). 'Not current smoker' was an independent correlate with reinfarction (relative risk, 1.9). The coronary anatomy did not differ among the current smokers, ex-smokers, and never-smokers. CONCLUSIONS. The strong independent correlation of pulmonary edema/cardiogenic shock with death suggests that thrombolysis is not sufficient to improve survival in these patients. The higher mortality in patients with versus without prior AMI in the conservative strategy suggests that early catheterization and revascularization of these patients might be beneficial. Conversely, the higher mortality in diabetes without prior AMI in the invasive than in the conservative strategy suggests that early aggressive management might not be suitable in this subgroup except for clinical indications. Reinfarction was not predictable by clinical variables except by history of angina. The finding that 'not current smoker' was an independent correlate with reinfarction was unexpected
— id: 37084, year: 1992, vol: 85, page: 1254, stat: Journal Article,

Hemorrhagic events during therapy with recombinant tissue-type plasminogen activator, heparin, and aspirin for acute myocardial infarction. Results of the Thrombolysis in Myocardial Infarction (TIMI), Phase II Trial
Bovill EG; Terrin ML; Stump DC; Berke AD; Frederick M; Collen D; Feit F; Gore JM; Hillis LD; Lambrew CT; et al.
1991 Aug 15;115(4):256-265, Annals of internal medicine
OBJECTIVES: To assess the effects of invasive procedures, hemostatic and clinical variables, the timing of beta-blocker therapy, and the doses of recombinant plasminogen activator (rt-PA) on hemorrhagic events. DESIGN: A multicenter, randomized, controlled trial. SETTING: Hospitals participating in the Thrombolysis in Myocardial Infarction, Phase II trial (TIMI II). INTERVENTIONS: Patients received rt-PA, heparin, and aspirin. The total dose of rt-PA was 150 mg for the first 520 patients and 100 mg for the remaining 2819 patients. Patients were randomly assigned to an invasive strategy (coronary arteriography with percutaneous angioplasty [if feasible] done routinely 18 to 48 hours after the start of thrombolytic therapy) or to a conservative strategy (coronary arteriography done for recurrent spontaneous or exercise-induced ischemia). Eligible patients were also randomly assigned to either immediate intravenous or deferred beta-blocker therapy. MEASUREMENTS: Patients were monitored for hemorrhagic events during hospitalization. MAIN RESULTS: In patients on the 100-mg rt-PA regimen, major and minor hemorrhagic events were more common among those assigned to the invasive than among those assigned to the conservative strategy (18.5% versus 12.8%, P less than 0.001). Major or minor hemorrhagic events were associated with the extent of fibrinogen breakdown, peak rt-PA levels, thrombocytopenia, prolongation of the activated partial thromboplastin time (APTT) to more than 90 seconds, weight of 70 kg or less, female gender, and physical signs of cardiac decompensation. Immediate intravenous beta-blocker therapy had no important effect on hemorrhagic events when compared with delayed beta-blocker therapy. Intracranial hemorrhages were more frequent among patients treated with the 150-mg rt-PA dose than with the 100-mg rt-PA dose (2.1% versus 0.5%, P less than 0.001). The extent of the plasmin-mediated hemostatic defect was also greater in patients receiving the 150-mg dose. CONCLUSIONS: Increased morbidity due to hemorrhagic complications is associated with an invasive management strategy in patients with acute myocardial infarction. Our findings show the complex interaction of several factors in the occurrence of hemorrhagic events during thrombolytic therapy
— id: 37087, year: 1991, vol: 115, page: 256, stat: Journal Article,

Multifaceted echocardiographic approach to the diagnosis of a ruptured sinus of Valsalva aneurysm
Katz ES; Cziner DG; Rosenzweig BP; Attubato M; Feit F; Kronzon I
1991 Sep-Oct;4(5):494-498, Journal of the American Society of Echocardiography
— id: 13927, year: 1991, vol: 4, page: 494, stat: Journal Article,

Safety and efficacy of a new regimen of intravenous recombinant tissue-type plasminogen activator potentially suitable for either prehospital or in-hospital administration
McKendall GR; Attubato MJ; Drew TM; Feit F; Sharaf BL; Thomas ES; Teichman S; McDonald MJ; Williams DO
1991 Dec;18(7):1774-1778, Journal of the American College of Cardiology
The safety and efficacy of a new regimen of intravenous recombinant tissue-type plasminogen activator (rt-PA) potentially suitable for either pre- or in-hospital administration were assessed in 60 patients with acute myocardial infarction in an open label coronary angiographic study. The regimen consisted of a 20-mg bolus dose followed 30 min later by a delayed infusion of 80 mg over 2 h. This regimen was designed to facilitate prehospital administration of rt-PA. Infarct-related artery patency (Thrombolysis in Myocardial Infarction [TIMI] grade 2 or 3 flow) was observed in 40 of 53 patients at 60 min (75.5%, 95% confidence intervals [CI] 61% to 84%) and in 55 of 60 patients at 90 min (91.7%, 95% CI 80% to 95%) after the rt-PA bolus. By 90 min the majority of patients (55%) exhibited TIMI grade 3 flow; infarct artery patency at 120 min was 84.9%. During hospitalization definite recurrent ischemia occurred in nine patients (15%); nonfatal recurrent infarction was noted in one (1.7%). Four patients (6.7%) experienced major bleeding, including one with intracranial bleeding. There were seven deaths (11.7%). Mortality was significantly influenced by the occurrence of cardiogenic shock, which was present in five patients at the time of enrollment. Blood fibrinogen levels were obtained before and during rt-PA infusion. At baseline and 30 and 150 min after the bolus dose, the mean fibrinogen level (+/- SD) was 284.83 +/- 77.39, 237.96 +/- 76.92 and 192.04 +/- 57.82 mg/dl, respectively. Compared with the baseline value, there was a significant (p less than 0.05) decrease in fibrinogen at both 30 and 150 min.(ABSTRACT TRUNCATED AT 250 WORDS)
— id: 37086, year: 1991, vol: 18, page: 1774, stat: Journal Article,

Left ventricle-to-ascending aorta communication complicating composite graft repair undetected by aortography: diagnosis by transesophageal echocardiography
Rosenzweig BP; Donahue T; Attubato M; Feit F; Kronzon I
1991 Nov-Dec;4(6):639-644, Journal of the American Society of Echocardiography
A 57-year-old man underwent composite ascending aortic conduit and prosthetic aortic valve repair of a sinus of Valsalva aneurysm. The patient's course was complicated by recurrent aneurysm formation caused by a communication between the left ventricular outflow tract and the ascending aorta outside the conduit. Transesophageal echocardiography documented the anatomic and functional characteristics of this complication, whereas aortography failed to demonstrate them. Findings at surgery confirmed the transesophageal echocardiogram results of a left ventricular outflow tract to aorta communication, a normal prosthetic aortic valve, and an intact distal anastomosis of the conduit with the aorta. Transesophageal echocardiography is a useful modality for the evaluation of composite graft repairs of the aortic valve and ascending aorta
— id: 13856, year: 1991, vol: 4, page: 639, stat: Journal Article,

Percutaneous double-balloon valvuloplasty of porcine bioprosthetic valves in the tricuspid position
Attubato MJ; Stroh JA; Bach RG; Slater J; Feit F
1990 Jul;20(3):202-204, Catheterization & cardiovascular diagnosis
This is a description of the first two reported cases of double-balloon valvuloplasty in the treatment of porcine bioprosthetic valve stenosis in the tricuspid position. In both cases, the double-balloon technique resulted in a better hemodynamic improvement than single-balloon valvuloplasty and was well tolerated. Double-balloon valvuloplasty is a reasonable alternative to surgical replacement of a stenotic bioprosthesis in the tricuspid position
— id: 37088, year: 1990, vol: 20, page: 202, stat: Journal Article,

The Thrombolysis in Myocardial Infarction (TIMI) Trial phase II: additional information and perspectives
Baim DS; Braunwald E; Feit F; Knatterud GL; Passamani ER; Robertson TL; Rogers WJ; Solomon RE; Williams DO
1990 Apr;15(5):1188-1192, Journal of the American College of Cardiology
Given the many thrombolytic agents and the number of ways in which they can be combined with mechanical revascularization, the treatment of acute myocardial infarction has been the subject of active study and lively debate, which are likely to continue for some time. Several studies, including TIMI IIA (2,3,10,22), have suggested that immediate catheterization and angioplasty offer no clinical benefit and have a greater complication rate than a more delayed invasive strategy, but TIMI II (1) and SWIFT (16) trials have suggested that an even more conservative strategy of reserving catheterization and coronary angioplasty after thrombolytic therapy for patients with recurrent spontaneous or exercise-induced ischemia may be the most desirable approach for the majority of patients similar to those entered into these trials
— id: 37089, year: 1990, vol: 15, page: 1188, stat: Journal Article,

Thrombolysis in Myocardial Infarction (TIMI) phase II trial: outcome comparison of a "conservative strategy" in community versus tertiary hospitals. The TIMI Research Group [see comments]
Feit F; Mueller HS; Braunwald E; Ross R; Hodges M; Herman MV; Knatterud GL
1990 Dec;16(7):1529-1534, Journal of the American College of Cardiology
In the conservative strategy arm of phase II of the Thrombolysis in Myocardial Infarction (TIMI) trial, 1,461 patients were treated with intravenous recombinant tissue-type plasminogen activator (rt-PA). Coronary angiography, with angioplasty if feasible, was to be performed only for recurrent spontaneous or exercise-induced ischemia. In this study results in patients treated by this strategy in community and tertiary hospitals are compared. Despite similar baseline findings in the two groups, coronary angiography was performed within 42 days in more patients (542 [48%] of 1,155) initially admitted to a tertiary hospital (on-site coronary angiography/angioplasty available) than in those (94 [32%] of 306) admitted to a community hospital (transfer to tertiary hospital for coronary angiography/angioplasty) (p less than 0.001). This different approach resulted in a greater use of coronary angioplasty (203 [18%] of 1,155 versus 32 [11%] of 306, p less than 0.01), coronary artery bypass surgery (133 [12%] of 1,155 versus 23 [8%] of 306, p less than 0.05) and blood transfusions (139 [12%] of 1,155 versus 17 [5.5%] of 306, p less than 0.001) in patients admitted to a tertiary than to a community hospital. However, there were no significant differences between the two groups in mortality, recurrent myocardial infarction or left ventricular function. These results demonstrate that a conservative strategy after treatment of acute myocardial infarction with rt-PA is applicable in the community hospital setting
— id: 14266, year: 1990, vol: 16, page: 1529, stat: Journal Article,

A RANDOMIZED, PLACEBO-CONTROLLED, TRIAL OF TISSUE PLASMINOGEN- ACTIVATOR IN ELDERLY PATIENTS WITH ACUTE MYOCARDIAL-INFARCTION
Feit, F; Breed, J; Anderson, JL; Attubato, MJ; Davison, R; Sherrid, MV; Teichman, S
1990 Oct;82(4):666-666, Circulation
— id: 31913, year: 1990, vol: 82, page: 666, stat: Journal Article,

Cardiac lymphoma in the acquired immunodeficiency syndrome
Goldfarb A; King CL; Rosenzweig BP; Feit F; Kamat BR; Rumancik WM; Kronzon I
1989 Dec;118(6):1340-1344, American heart journal
— id: 10405, year: 1989, vol: 118, page: 1340, stat: Journal Article,

Late thrombolytic therapy preserves left ventricular function in patients with collateralized total coronary occlusion: primary end point findings of the Second Mount Sinai-New York University Reperfusion Trial
Rentrop KP; Feit F; Sherman W; Stecy P; Hosat S; Cohen M; Rey M; Ambrose J; Nachamie M; Schwartz W; et al.
1989 Jul;14(1):58-64, Journal of the American College of Cardiology
The change in left ventricular ejection fraction from preintervention to predischarge was prospectively assessed in 393 patients with acute myocardial infarction. Within 12 h of symptom onset (mean 6.3 +/- 2.7 h), patients were randomly assigned to a double-blind intracoronary infusion of streptokinase, nitroglycerin, both streptokinase and nitroglycerin or conventional therapy without acute cardiac catheterization. Treatment effects were also assessed in prospectively defined angiographic subsets. There was a significant interaction between streptokinase and nitroglycerin (p less than 0.01), resulting in an increase in ejection fraction of 3.9 percentage units in the combined treatment arm (p less than 0.001). Patients with collateral flow to a totally obstructed infarct-related artery showed a significant improvement over those without collateral flow in the streptokinase (5.4 +/- 2.5%) and streptokinase-nitroglycerin (10.6 +/- 2.7%) arms, but not in the nitroglycerin arm. Time to treatment did not influence the change in ejection fraction. In patients with initial subtotal occlusion, thrombolytic therapy was of no short-term benefit because ejection fraction increased by 6% in all three intervention arms. These findings indicate that relatively late thrombolytic therapy results in significant myocardial salvage in those patients with collateralized total coronary occlusion. This benefit is potentiated by concomitant nitroglycerin therapy
— id: 37091, year: 1989, vol: 14, page: 58, stat: Journal Article,

Serial angiographic assessment of coronary artery obstruction and collateral flow in acute myocardial infarction. Report from the second Mount Sinai-New York University Reperfusion Trial
Rentrop KP; Feit F; Sherman W; Thornton JC
1989 Nov;80(5):1166-1175, Circulation
In the Second Mt. Sinai-New York University Reperfusion Trial, in which change of ejection fraction was the primary end point, the following secondary end points were prospectively assessed by serial coronary angiography: patency of the infarct artery both before intervention and 10-14 days later, acute and delayed recanalization rates, presence or absence of collateral flow, and complication rates of acute interventional catheterization. We assigned 393 patients randomly to groups receiving acute cardiac catheterization and a double-blind intracoronary infusion of streptokinase (SK arm), both streptokinase and nitroglycerin (SK-NTG arm), nitroglycerin alone (NTG arm), or conventional therapy without acute catheterization (control arm). Prospective stratification was based on duration of infarct pain before randomization: group A, less than 2 hours; Group B, 2-12 hours. Baseline patency rates were comparable in patients studied within 6 hours (30%, 40 of 135) and those studied later (24%, 32 of 133). This finding refutes the hypothesis that spontaneous recanalization occurs frequently after 6 hours. The acute recanalization rates of the SK arm (60%, 40 of 67) and the SK-NTG arm (63%, 29 of 62) did not differ. During streptokinase infusion, more vessels recanalized in group A (81%, 22 of 27) than in group B (56%, 57 of 102) (p less than 0.01); this was due to a significant reduction of recanalization rates from 75% (48 of 64) to 45% (26 of 62) with treatment after 6 hours (p less than 0.01). Delayed recanalization, that is, patency at end point but not postintervention, was seen in 17% (17 of 100) of total occlusions treated with streptokinase. In group A, all total occlusions treated with streptokinase recanalized either acutely (20 of 22) or delayed (two of 22), whereas in group B, 23% (18 of 78) remained obstructed. The reocclusion rate in the SK arms was 17% (11 of 65). In the NTG arm, recanalization occurred during intervention in 4% (two of 47) and delayed in 45% (21 of 47). At end-point angiography, the patency rates of the NTG arm (62%, 41 of 66) and the control arm (58%, 36 of 62) were comparable; those of the SK arms were higher (75%, 105 of 140) (p less than 0.01). Total occlusion was associated with collateral flow in 33% (66 of 199) at baseline; the prevalence of collaterals did not increase with time to angiography, which indicates that they had developed before the index event.(ABSTRACT TRUNCATED AT 400 WORDS)
— id: 37090, year: 1989, vol: 80, page: 1166, stat: Journal Article,

The effect of aspirin on the hemodynamic response to nitroglycerin
Levin RI; Feit F
1988 Jul;116(1 Pt 1):77-84, American heart journal
The role of prostaglandins in mediating the hemodynamic response to nitroglycerin in vivo is controversial. To determine the effect of inhibiting prostaglandin production on the response to nitroglycerin, either placebo or aspirin (650 mg) was administered 1 hour prior to the administration of nitroglycerin (432 micrograms) sublingually to 40 healthy volunteers in a double-blind, randomized, cross-over study. Prior to nitroglycerin administration, blood pressure and pulse rate were determined noninvasively every 2 minutes until stable conditions were reached, and then after nitroglycerin administration determinations were made every 1 minute for the first 10 minutes, every 2 minutes for the next 10 minutes, and every 5 minutes until 30 minutes had elapsed. At peak response in the placebo study, nitroglycerin lowered systolic pressure from 117 +/- 10 to 111 +/- 10 mm Hg (p less than 0.0001). Unexpectedly, nitroglycerin increased diastolic pressure from 75 +/- 8 to 80 +/- 7 mm Hg (p less than 0.005), thus reducing pulse pressure significantly. Pulse rate after nitroglycerin increased from 72 +/- 11 to 85 +/- 14 (p less than 0.001). Aspirin slightly modified the pattern of response at 1 minute but altered neither the peak hemodynamic responses nor the areas under the time-pressure and time-pulse curves. Thus nitroglycerin-induced prostaglandin production does not play a major role in the systemic hemodynamic response to nitroglycerin in vivo
— id: 11051, year: 1988, vol: 116, page: 77, stat: Journal Article,

Determinants and protective potential of coronary arterial collaterals as assessed by an angioplasty model
Rentrop KP; Thornton JC; Feit F; Van Buskirk M
1988 Apr 1;61(10):677-684, American journal of cardiology
Two indexes of collateral blood flow, the ratio of distal coronary occlusion pressure/aortic pressure (DCOP/Pao) and angiographic collateral class were determined during elective angioplasty in 36 patients with normal left ventricular function. The association between collateral indexes and 8 anatomic and clinical variables was assessed. A reduction in luminal diameter by greater than or equal to 70% predicted angiographically demonstrable collaterals with 100% specificity and 85% sensitivity. Lesion severity (stenosis) correlated with both collateral class and DCOP/Pao: DCOP/Pao = 2.8809 - 0.0729 X stenosis + 0.00049 X stenosis. The data suggest a quantitative relation between lesion severity and collateral development beyond a threshold value of 70% stenosis. Left ventricular ejection fraction during ischemia caused by balloon occlusion (EFo) was found to be primarily determined by lesion location; however, collateral flow modified EFo significantly. For mid-left anterior descending and right coronary artery: EFo = 59 + 26 X (DCOP/Pao); for proximal left anterior descending artery: EFo = 24 + 89 X (DCOP/Pao). A model predicting the hemodynamic and clinical consequences of abrupt coronary closure based on lesion location and severity was developed. In the second study phase, this model was tested retrospectively in a different group of 23 patients who experienced coronary occlusion as a complication of angioplasty. The data of both study phases suggest that left ventricular function and clinical outcome after abrupt coronary closure are determined by an interaction between location of the coronary artery obstruction and the amount of collateral flow. Lesion severity and the extent of functional impairment resulting from abrupt coronary closure are inversely related
— id: 37092, year: 1988, vol: 61, page: 677, stat: Journal Article,

Systolic antegrade tricuspid blood flow--a sign of severe prosthetic valve stenosis
Rosenzweig BP; Kronzon I; Feit F; Stecy PJ; Nachamie MS; Politzer F
1988 Mar;115(3):693-696, American heart journal
— id: 11161, year: 1988, vol: 115, page: 693, stat: Journal Article,

ST SEGMENT DEPRESSION MANIFESTED ONLY IN THE POST EXERCISE PERIOD AS AN INDICATOR OF CORONARY-ARTERY DISEASE
Fox, SN; Reitano, JM; Rey, MJ; Goodfield, P; Feit, F; Stecy, PJ; Rubler, S
1987 Apr;35(3):A278-A278, Clinical research
— id: 31363, year: 1987, vol: 35, page: A278, stat: Journal Article,

Cardiogenic shock due to antihistamine overdose. Reversal with intra-aortic balloon counterpulsation
Freedberg RS; Friedman GR; Palu RN; Feit F
1987 Feb 6;257(5):660-661, JAMA
— id: 35864, year: 1987, vol: 257, page: 660, stat: Journal Article,

THE 2ND MT-SINAI NYU REPERFUSION TRIAL - MAIN END-POINTS
Rentrop, P; Feit, F
1987 Feb;9(2):A239-A239, Journal of the American College of Cardiology
— id: 31282, year: 1987, vol: 9, page: A239, stat: Journal Article,

RECRUITABLE COLLATERALS PREDICTED BY LESION SEVERITY
Rentrop, P; Thornton, J; Feit, F; Cohen, M; Cohen, B
1987 Feb;9(2):A182-A182, Journal of the American College of Cardiology
— id: 31280, year: 1987, vol: 9, page: A182, stat: Journal Article,

Percutaneous balloon valvuloplasty for stenosis of a porcine bioprosthesis in the tricuspid valve position
Feit F; Stecy PJ; Nachamie MS
1986 Aug 1;58(3):363-364, American journal of cardiology
— id: 37093, year: 1986, vol: 58, page: 363, stat: Journal Article,

THE MOUNT-SINAI NYU REPERFUSION TRIAL - EJECTION FRACTION (EF) EFFECTS
Rentrop, P; Feit, F; Sherman, W; Stecy, P; Cohen, M; Thornton, J
1986 Oct;74(4):366-366, Circulation
— id: 31013, year: 1986, vol: 74, page: 366, stat: Journal Article,

CORRELATION OF LEFT-VENTRICULAR FUNCTION AND ELECTROCARDIOGRAPHY AFTER MYOCARDIAL REPERFUSION
SHERMAN, W; REY, M; FEIT, F; STECY, P; SANGER, J; HOROWITZ, S; FAGERSTROM, R; HOLT, J; RENTROP, P
1986 OCT ;74(4):479-479, Circulation
— id: 41340, year: 1986, vol: 74, page: 479, stat: Journal Article,

THE EFFECT OF ASPIRIN ON THE PHYSIOLOGIC RESPONSE TO NITROGLYCERIN
Levin, RI; Feit, F; Jaffe, E
1985 ;33(3):A744-A744, Clinical research
— id: 30724, year: 1985, vol: 33, page: A744, stat: Journal Article,

THE EFFECT OF ASPIRIN ON THE PHYSIOLOGIC RESPONSE TO NITROGLYCERIN
Levin, RI; Feit, F; Jaffe, EA
1985 ;72(4):460-460, Circulation
— id: 30722, year: 1985, vol: 72, page: 460, stat: Journal Article,

THE PHYSIOLOGIC RESPONSE TO NITROGLYCERIN IS NOT MEDIATED BY PROSTACYCLIN
Levin, RI; Feit, F; Jaffe, EA
1985 ;33(2):A520-A520, Clinical research
— id: 30750, year: 1985, vol: 33, page: A520, stat: Journal Article,

Methionine intolerance: a possible risk factor for coronary artery disease
Murphy-Chutorian DR; Wexman MP; Grieco AJ; Heininger JA; Glassman E; Gaull GE; Ng SK; Feit F; Wexman K; Fox AC
1985 Oct;6(4):725-730, Journal of the American College of Cardiology
Homocystinuria, an inherited disorder associated with premature atherosclerosis, represents a severe form of methionine intolerance. To analyze the importance of milder forms of methionine intolerance in the genesis of vascular disease, the relation between provokable methionine intolerance and coronary artery disease was investigated. In a group of 138 men, aged 31 to 65 years (mean 53), referred for cardiac catheterization, plasma homocystine was measured before and 6 hours after an oral l-methionine load (0.1 g/kg). Thirty-nine subjects found to have normal coronary arteries had a mean post-load plasma homocystine level of 0.59 +/- 0.37 mumol/liter. A criterion at the 95th percentile (1.64 SD above the mean) was selected and applied to the remaining 99 subjects with coronary artery disease (0.70 +/- 0.68 mumol/liter). Sixteen (16%) of 99 subjects with coronary artery disease exceeded this level as compared with 1 (2%) of 39 subjects without coronary artery disease (p less than 0.04). The risk of coronary artery disease in men with provokable methionine intolerance was increased sevenfold as estimated by the odds ratio. By correlation matrix and multivariate regression analyses, provokable homocystinemia was predictive of coronary artery disease and was independent of tobacco smoking, hypertension, diabetes mellitus, serum cholesterol and age. It is proposed that men with mild methionine intolerance exposed to the high methionine content of the Western diet may develop intermittent homocystinemia and thus may be at greater risk for the development of coronary artery disease
— id: 18921, year: 1985, vol: 6, page: 725, stat: Journal Article,

METHIONINE INTOLERANCE - A NEWLY IDENTIFIED RISK FACTOR FOR CORONARY-ARTERY DISEASE
MURPHYCHUTORIAN, D; WEXMAN, MP; GRIECO, AJ; HEININGER, JA; GAULL, GE; GLASSMAN, E; FEIT, F; WEXMAN, KJ; NG, S; FOX, AC
1984 ;3(2):572-572, Journal of the American College of Cardiology
— id: 41027, year: 1984, vol: 3, page: 572, stat: Journal Article,

Effects of intracoronary streptokinase and intracoronary nitroglycerin infusion on coronary angiographic patterns and mortality in patients with acute myocardial infarction
Rentrop KP; Feit F; Blanke H; Stecy P; Schneider R; Rey M; Horowitz S; Goldman M; Karsch K; Meilman H; Fox AC; et al.
1984 Dec 6;311(23):1457-1463, New England journal of medicine
We randomly assigned patients with a clinical diagnosis of acute myocardial infarction to one of four treatment groups: intracoronary streptokinase, intracoronary nitroglycerin, intracoronary streptokinase and intracoronary nitroglycerin, or conventional therapy without initial angiography. Of 124 patients 122 sustained acute myocardial infarction. Initial angiography revealed total occlusion of the coronary artery responsible for infarction in 67 per cent (61 of 91). Acute recanalization occurred in 74 per cent (32 of 43) of patients receiving streptokinase but in only 6 per cent (1 of 18) of patients treated with nitroglycerin alone (P less than 0.01). At angiography of all four groups on Day 10 to 14 the vessel responsible for acute myocardial infarction was patent in 77 per cent (71 of 92) of patients; there was no difference among groups, indicating gradual, endogenous thrombolysis in patients not treated with streptokinase. Patients with subtotal obstruction initially had significant improvement in left ventricular function, significantly lower peak creatine kinase levels, and a trend toward lower mortality than patients with total occlusion initially. Mortality at six months in patients receiving streptokinase (21 per cent, 13 of 62) did not differ significantly from that in patients not treated with streptokinase (10 per cent, 6 of 61). Additional studies will be necessary to assess treatment effects in the angiographic subsets identified by this trial
— id: 32402, year: 1984, vol: 311, page: 1457, stat: Journal Article,

LATE VENTRICULAR ECTOPY IN THE MT-SINAI-NYU MYOCARDIAL INFARCT REPERFUSION TRIAL
REY, M; SIEGEL, S; FEIT, F; NACHAMIE, M; EHRICH, M; STECY, P; BLANKE, H; SCHNEIDER, R; RENTROP, P
1983 ;68(4):410-410, Circulation
— id: 40627, year: 1983, vol: 68, page: 410, stat: Journal Article,

SINUS NODE DYSFUNCTION IN SPINAL-CORD INJURY WITH QUADRIPLEGIA
NICOSIA, TA; MERCURIO, P; FEIT, F; FOX, AC
1981 ;47(2):393-393, American journal of cardiology
— id: 40266, year: 1981, vol: 47, page: 393, stat: Journal Article,

NUCLEOSIDE RELEASE REFLECTS CHANGING OR PROLONGED REGIONAL MYOCARDIAL ISCHEMIA
FEIT, F; FOX, AC; NACHAMIE, M; GROSS, RI; SNIVELY, SL; CUNNINGHAM, JN
1980 ;28(2):A168-A168, Clinical research
— id: 84003, year: 1980, vol: 28, page: A168, stat: Journal Article,

REDUCED NUMBER OF CARDIAC BETA-ADRENERGIC RECEPTORS IN RAT PHEOCHROMOCYTOMA
Shenkman, L; Saito, M; Feit, F; Goldstein, M
1979 ;27(3):A595-A595, Clinical research
— id: 30078, year: 1979, vol: 27, page: A595, stat: Journal Article,

Enhancement of nitroblue tetrazolium dye reduction by leukocytes exposed to a component of complement in the absence of phagocytosis
Goldstein IM; Feit F; Weissmann G
1975 Jan;114(1 Pt 2):516-518, Journal of immunology
Enhancement of in vitro nitroblue tetrazolium dye reduction by human polymorphonuclear leukocytes may be mediated by a low molecular weight fluid phase component of the complement system. This occurs in the absence of phagocytosis and is associated with an increase in leukocyte hexose monophosphate shunt activity. The stimulatory component may be generated by activating the alternate complement pathway in serum, and shares many of the properties of human C5a. Thus, the enhanced spontaneous reduction of nitroblue tetrazolium by leukocytes from patients with bacterial sepsis may not necessarily be due to the phagocytic activity of these cells, but rather may occur as a consequence of in vivo complement activation by either intact microorganisms or their products
— id: 37094, year: 1975, vol: 114, page: 516, stat: Journal Article,