Marc Cohen

Beth Israel Medical Center, New York City, New York, United States

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Publications (120)836.33 Total impact

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    ABSTRACT: Enoxaparin is increasingly used for the anticoagulation of patients undergoing percutaneous coronary intervention (PCI). Several reports have suggested the utility of using point of care tests in monitoring the anticoagulation levels of enoxaparin in patients undergoing PCI. The objective of this study was to evaluate a new point-of-care test (POCT) HEMONOX in monitoring the anticoagulant effect of enoxaparin in non citrated fresh whole blood samples from patients undergoing elective PCI procedure. Following IRB approval, blood samples were obtained from fifty-four patients who received two sequential intravenous doses of enoxaparin; 0.1 mg/kg followed 5 min later by 0.4 mg/kg for a total of 0.5 mg/kg. Blood was drawn at baseline and at 5, 10, 30 and 60 min post first bolus for evaluation in the clot-based POCT HEMONOX, ACT and aPTT and the chromogenic anti-Xa activity assay. HEMONOX clotting time (CT) at baseline was 62.6 +/- 6.2 secs, (n = 32) in healthy donors and statistically higher in PCI patients (71.6 +/- 9.1 secs, p = 0.0001). The peak HEMONOX response that was always achieved at 10 min post bolus was >100 secs in all 54 patients, of these 83% yielded CT >150 secs (range: 150-466). There was no detectable anti-Xa activity level at baseline while peak HEMONOX CT corresponded to therapeutic levels (0.85 +/- 0.14 U/ml; range: 0.61-1.34). Both HEMONOX CT and anti-Xa level significantly decreased at the time of sheath removal. HEMONOX CT at peak response suggested 3 patient subgroups with different levels of sensitivity to enoxaparin: low, intermediate and high responders. The correlation between anti-Xa activity level and HEMONOX CT was >or=0.85 in each patient subgroup when data from the 3 critical time points; baseline (absence of drug), peak response (10 min post bolus) and sheath removal (60 min post bolus) were analyzed. The correlation diminished to >or=0.83 when the analyses included data from all 5 time points [baseline, 5, 10, 30, and 60 min post bolus]. The HEMONOX test was the most sensitive POCT to measure the anticoagulant effects of enoxaparin. All patients completed PCI successfully. The HEMONOX test may be able to guide anticoagulation with enoxaparin during PCI. The HEMONOX assay is a one step whole blood coagulation test performed on the HEMOCHRON Jr. Signature + POC system. The method was evaluated to monitor the anticoagulant level of enoxaparin in blood samples from patients undergoing PCI after receiving an intravenous dose of 0.5 mg/kg. The results suggest a clear distinction of HEMONOX CT between the baseline value of untreated patients and patients achieving therapeutic enoxaparin levels.
    Journal of Thrombosis and Thrombolysis 05/2006; 21(2):137-45. · 1.99 Impact Factor
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    ABSTRACT: We undertook a prospective electrocardiogram (ECG) substudy in the ESSENCE trial and hypothesized that patient subgroups with ST-segment deviation would experience greater benefit from enoxaparin, as compared with unfractionated heparin (UFH). Of the 3171 patients in the trial, 3087 had a qualifying ECG available for analysis by the core laboratory. Patients were divided into 4 mutually exclusive groups based upon the qualifying ECG: (1) ST-segment elevation, (2) ST-segment depression, (3) T-wave inversions, or (4) others. The 30-day and 1-year primary outcomes (death, myocardial infarction, or recurrent angina) were significantly lower among patients with ST elevation or ST depression who received enoxaparin, as compared with UFH (20.8% vs 28.0%, P = .0019 and 32% vs 40.4%, P = .0011, respectively). The greatest absolute benefit of enoxaparin over UFH was seen in patients with ST depression (primary end point at 30 days, 24.6% vs 32.4%, P = .018; at 1 year, 35.5% vs 44.5%, P = .012). Specific recognition of patients with ST-segment depression appears to identify those not only at high risk for adverse outcome, but also patients most likely to derive the greatest benefit from enoxaparin, as compared with UFH therapy.
    American heart journal 05/2006; 151(4):791-7. · 4.65 Impact Factor
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    ABSTRACT: The best anticoagulation strategy for patients undergoing percutaneous coronary intervention (PCI) remains controversial. The primary objective of this study was to assess the feasibility of immediate sheath removal post-PCI in patients given a single low-dose intravenous (IV) bolus of enoxaparin as the sole anticoagulant. In 53 patients with stable coronary disease undergoing elective PCI, a single IV bolus of 0.5 mg per kg enoxaparin was administered 10 minutes before PCI. Patients were pretreated with aspirin 100 mg and clopidogrel 300 mg. The femoral access sheaths were removed immediately after PCI by manual compression. Major and minor bleeding and coronary thrombosis were recorded. Anti-Xa levels were measured before, during and after PCI. One patient had an intracoronary thrombus 60 minutes after enoxaparin administration, and there was 1 ischemic stroke. Fifty-one of the 53 patients had their sheaths successfully pulled immediately post-PCI. One patient had a pseudoaneurysm requiring surgical repair, and 1 patient had a minor bleed. Postprocedural elevation of CK-MB > 3 times the upper limit of normal occurred in 7 patients (13.2%). Anti-Xa activity was 0.56 +/- 0.16 at 10 minutes post-IV injection, and then progressively decreased to 0.14 +/- 0.09 IU/ml at 6 hours after injection. Ten minutes after IV enoxaparin, 12 patients (23.5%) had anti-Xa levels < 0.5 IU/ml. Immediate removal of femoral sheaths, after a single low-dose of IV enoxaparin for elective stenting appears feasible. However, a sizeable proportion of patients achieved anti-Xa levels below the widely agreed upon "therapeutic" level after injection.
    The Journal of invasive cardiology 02/2006; 18(2):45-8. · 1.57 Impact Factor
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    ABSTRACT: The SYNERGY trial comparing enoxaparin and unfractionated heparin in high-risk patients with acute coronary syndromes (ACS) showed that enoxaparin was not inferior to unfractionated heparin in reducing death or nonfatal myocardial infarction (MI) at 30 days. To evaluate continued risk in this patient cohort through 6-month and 1-year follow-up. Overall, 9978 patients were randomized from August 2001 through December 2003 in 487 hospitals in 12 countries. Patients were followed up for 6 months and for 1 year. Six-month outcomes were death, nonfatal MI, revascularization procedures, stroke, and site-investigator-reported need for rehospitalization; 1-year outcome was all-cause death. Six-month and 1-year follow-up data were available for 9957 (99.8%) and 9608 (96.3%) of 9978 patients, respectively; 541 patients (5.4%) had died at 6 months and 739 (7.4%) at 1 year. Death or nonfatal MI at 6 months occurred in 872 patients receiving enoxaparin (17.6%) vs 884 receiving unfractionated heparin (17.8%) (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.89-1.07; P = .65). In the subgroup of patients receiving consistent therapy, ie, only enoxaparin or unfractionated heparin during the index hospitalization (n = 6138), a reduction in death or nonfatal MI with enoxaparin was maintained at 180 days (HR, 0.85; 95% CI, 0.75-0.95; P = .006). Rehospitalization within 180 days occurred in 858 patients receiving enoxaparin (17.9%) and 911 receiving unfractionated heparin (19.0%) (HR, 0.94; 95% CI, 0.85-1.03; P = .17). One-year all-cause death rates were similar in the 2 treatment groups (380/4974 [7.6%] for enoxaparin vs 359/4948 [7.3%] for unfractionated heparin; HR, 1.06; 95% CI, 0.92-1.22; P = .44). One-year death rates in patients receiving consistent therapy were also similar (251/3386 [7.4%] for enoxaparin vs 213/2720 [7.8%] for unfractionated heparin; HR, 0.95; 95% CI, 0.79-1.14; P = .55). In the SYNERGY trial, patients continued to experience adverse cardiac events through long-term follow-up. The effect of enoxaparin on death or MI compared with that of unfractionated heparin at 6 months was similar to that observed at 30 days in the overall trial and in the consistent-therapy group. One-year death rates were also similar in both groups. High-risk patients with ACS remain susceptible to continued cardiac events despite aggressive Identifier: NCT00043784.
    JAMA The Journal of the American Medical Association 12/2005; 294(20):2594-600. · 29.98 Impact Factor
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    ABSTRACT: The standard of care for ST-segment elevation myocardial infarction (STEMI) is prompt coronary reperfusion with thrombolysis or percutaneous coronary intervention. Women have higher mortality rates than men following STEMI and fewer women are considered eligible for reperfusion therapy. We analyzed the impact of gender, and other factors, on the outcome and treatment of STEMI in the TETAMI trial and registry. This exploratory analysis included 2741 patients from Treatment with Enoxaparin and Tirofiban in Acute Myocardial Infarction (TETAMI) presenting with STEMI within 24 hours of symptom onset. The primary composite end point was the combined incidence of all-cause death, recurrent myocardial infarction, and recurrent angina, at 30 days. Three multivariate analyses were performed to determine predictors of not receiving reperfusion therapy, the composite end point, or death. The triple end point occurred in 17.8% of women versus 13.3% of men. Reperfusion therapy was utilized in 38.2% of women versus 47.3% in men. However, age > 75 years, delayed presentation, high systolic blood pressure (> 100) and region (South Africa), were significant, independent predictors of not receiving reperfusion therapy. Significant predictors of the triple end point included not receiving reperfusion therapy, age > 60 years, and higher Killip class. Predictors of death included age > 60 years, low systolic blood pressure, higher Killip class, high heart rate, delayed presentation, and region (South Africa and South America). Female gender was not an independent predictor of outcome or underutilization of reperfusion therapy. Factors more common in female STEMI patients (advanced age and delayed presentation) were associated with not receiving reperfusion therapy and adverse outcome. Increased awareness is needed to reduce delayed presentation after symptom onset, especially among women. Abbreviated abstract. In this analysis of 2741 ST-segment elevation myocardial infarction patients in the TETAMI trial and registry, a trend was observed for women being less likely to receive reperfusion therapy and more likely to have an adverse outcome than men. This was related to factors more common in female patients (advanced age and delayed presentation), and showed that an increased awareness is needed to reduce delayed presentation after symptom onset, especially among women.
    Journal of Thrombosis and Thrombolysis 06/2005; 19(3):155-61. · 1.99 Impact Factor
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    ABSTRACT: Enoxaparin is increasingly used for the anticoagulation of patients undergoing percutaneous coronary intervention (PCI) alone or in conjunction with GpIIb/IIIa platelet antagonists. The purpose of this study was to evaluate a newly developed HEMONOX point-of-care test (POCT) for monitoring the effect of enoxaparin in the presence or absence of GpIIb/IIIa antagonists during PCI. Patients received two consecutive doses of enoxaparin (total 0.5 mg/kg) separated by a 5-minute interval either alone (n = 21) or in combination with a GpIIb/IIIa inhibitor following standard practice (n = 18). POCT HEMONOX, traditional coagulation tests, and plasma anti-Xa chromogenic activity assay were performed at baseline and post bolus. HEMONOX clotting time (CT) at baseline was identical in the enoxaparin (69.0 ± 8.0 seconds) and enoxaparin/GpIIb/IIIa (71.0 ± 8.0 seconds) treatment groups. HEMONOX CT achieved peak value at 10 minutes post initial dose (P < 0.0001) and then decreased at sheath removal (60 minutes post bolus; P = 0.001) in the two groups. HEMONOX peak response varied among patients, ranging from 130 to 431 (enoxaparin) and 104 to 386 (enoxaparin/GpIIb/IIIa) seconds, which corresponded to therapeutic anti-Xa levels of 0.69-1.14 and 0.61-1.10 U/mL, respectively. Mean HEMONOX CT was reduced 50 seconds in the presence of GpIIb/IIIa antagonists, which was associated with a reduction of anti-Xa activity (P = 0.038) but remained within therapeutic range. GpIIb/IIIa treatment did not alter the correlation between HEMONOX CT and anti-Xa activity levels (r = 0.85 vs 0.84); eptifibatide and abciximab yielded the best correlation (r > 0.90). HEMONOX was the most sensitive monitoring POCT during PCI.
    Point of Care The Journal of Near-Patient Testing & Technology 02/2005; 4(1):30-35.
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    ABSTRACT: Clinical trials and accompanying substudies in patients with acute coronary syndromes (ACS) have over the last several years yielded a wealth of knowledge about the pathophysiology and management of this high-risk condition. The Superior Yield of the New strategy of Enoxaparin, Revascularization, and GlYcoprotein IIb/IIIa inhibitors (SYNERGY) trial is a large-scale, randomized, controlled trial evaluating the effect of enoxaparin and unfractionated heparin on death and myocardial infarction in high-risk patients presenting with non-ST-segment elevation ACS. The SYNERGY Library has been designed as a coordinated series of investigations with simultaneous data acquisition on the same cohort of approximately 500 SYNERGY patients at 60 centers in North America. Specifically, electrocardiograms, coronary arteriograms, inflammatory markers, coagulation studies, and genetic samples will be collected and processed at core laboratory facilities, and the results will be stored in a central repository. This novel strategy for substudy investigation is unprecedented in cardiovascular clinical trials. The goal is to gain significant understanding about this patient population, discover new principles of pathophysiology, identify novel pharmacologic targets, and streamline further drug development. It is hoped that the SYNERGY Library will serve as a model for future substudy design to maximize academic insight within the framework of a large-scale, multicenter trial.
    American heart journal 09/2004; 148(2):269-76. · 4.65 Impact Factor
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    ABSTRACT: Enoxaparin has demonstrated advantages over unfractionated heparin in low- to moderate-risk patients with non-ST-segment elevation acute coronary syndromes (ACS) treated with a conservative strategy. To compare the outcomes of patients treated with enoxaparin vs unfractionated heparin and to define the role of enoxaparin in patients with non-ST-segment elevation ACS at high risk for ischemic cardiac complications managed with an early invasive approach. The Superior Yield of the New Strategy of Enoxaparin, Revascularization and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) trial was a prospective, randomized, open-label, multicenter, international trial conducted between August 2001 and December 2003. A total of 10 027 high-risk patients with non-ST-segment elevation ACS to be treated with an intended early invasive strategy were recruited. Subcutaneous enoxaparin (n = 4993) or intravenous unfractionated heparin (n = 4985) was to be administered immediately after enrollment and continued until the patient required no further anticoagulation, as judged by the treating physician. The primary efficacy outcome was the composite clinical end point of all-cause death or nonfatal myocardial infarction during the first 30 days after randomization. The primary safety outcome was major bleeding or stroke. The primary end point occurred in 14.0% (696/4993) of patients assigned to enoxaparin and 14.5% (722/4985) of patients assigned to unfractionated heparin (odds ratio [OR], 0.96; 95% confidence interval [CI], 0.86-1.06). No differences in ischemic events during percutaneous coronary intervention (PCI) were observed between enoxaparin and unfractionated heparin groups, respectively, including similar rates of abrupt closure (31/2321 [1.3%] vs 40/2364 [1.7%]), threatened abrupt closure (25/2321 [1.1%] vs 24/2363 [1.0%]), unsuccessful PCI (81/2281 [3.6%] vs 79/2328 [3.4%]), or emergency coronary artery bypass graft surgery (6/2323 [0.3%] vs 8/2363 [0.3%]). More bleeding was observed with enoxaparin, with a statistically significant increase in TIMI (Thrombolysis in Myocardial Infarction) major bleeding (9.1% vs 7.6%, P =.008) but nonsignificant excess in GUSTO (Global Utilization of Streptokinase and t-PA for Occluded Arteries) severe bleeding (2.7% vs 2.2%, P =.08) and transfusions (17.0% vs 16.0%, P =.16). Enoxaparin was not superior to unfractionated heparin but was noninferior for the treatment of high-risk patients with non-ST-segment elevation ACS. Enoxaparin is a safe and effective alternative to unfractionated heparin and the advantages of convenience should be balanced with the modest excess of major bleeding.
    JAMA The Journal of the American Medical Association 08/2004; 292(1):45-54. · 29.98 Impact Factor
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    ABSTRACT: We analyzed in-hospital mortality for patients treated with intra-aortic balloon counterpulsation from the Benchmark Counterpulsation Outcomes Registry (n = 25,136). In-hospital mortality was higher in patients who received only medical interventions (32.5%) than in those who underwent percutaneous (18.8%) and surgical (19.2%) interventions, and was greatest in the first days after hospital admission for all 3 intervention types. Therefore, diagnostic evaluation and treatment decisions should be made as early as possible, and physicians should be aware of associated risk factors in making choices for patients.
    The American Journal of Cardiology 08/2004; 94(2):181-5. · 3.21 Impact Factor
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    ABSTRACT: Antithrombin therapy has become a guidelines-recommended standard of care in the treatment of acute coronary syndromes (ACS), but recent trials comparing use of enoxaparin and unfractionated heparin in ACS have yielded less robust efficacy and safety results than have earlier trials of these antithrombin therapies. To systematically evaluate the end points of all-cause death and nonfatal myocardial infarction (MI), transfusion, and major bleeding observed in the 6 randomized controlled trials comparing enoxaparin and unfractionated heparin in treatment of ACS. The primary data sets for ESSENCE, A to Z, and SYNERGY were available at the Duke Clinical Research Institute. Baseline characteristics and event frequencies for TIMI 11B, ACUTE II, and INTERACT were provided by the principal investigator of each study. All 6 randomized controlled trials comparing enoxaparin and unfractionated heparin in non-ST-segment elevation ACS were selected for analysis. Efficacy and safety end points were extracted from the overall trial populations and the subpopulation receiving no antithrombin therapy prior to randomization. Systematic evaluation of the outcomes for 21 946 patients was performed using a random-effects empirical Bayes model. No significant difference was found in death at 30 days for enoxaparin vs unfractionated heparin (3.0% vs 3.0%; odds ratio [OR], 1.00; 95% confidence interval [CI], 0.85-1.17). A statistically significant reduction in the combined end point of death or nonfatal MI at 30 days was observed for enoxaparin vs unfractionated heparin in the overall trial populations (10.1% vs 11.0%; OR, 0.91; 95% CI, 0.83-0.99; number needed to treat, 107). A statistically significant reduction in the combined end point of death or MI at 30 days was also observed for enoxaparin in the populations receiving no prerandomization antithrombin therapy (8.0% vs 9.4%; OR, 0.81; 95% CI, 0.70-0.94; number needed to treat, 72). No significant difference was found in blood transfusion (OR, 1.01; 95% CI, 0.89-1.14) or major bleeding (OR, 1.04; 95% CI, 0.83-1.30) at 7 days after randomization in the overall safety population or in the population of patients receiving no prerandomization antithrombin therapy. In a systematic overview of approximately 22 000 patients across the spectrum of ACS, enoxaparin is more effective than unfractionated heparin in preventing the combined end point of death or MI.
    JAMA The Journal of the American Medical Association 08/2004; 292(1):89-96. · 29.98 Impact Factor
  • The Journal of invasive cardiology 07/2004; 16(6):340. · 1.57 Impact Factor
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    ABSTRACT: We reviewed the efficacy and safety of combination antithrombotic therapy with aspirin plus warfarin versus aspirin alone in patients with atherosclerotic heart disease. We performed a comprehensive MEDLINE search of English-language reports published between 1966 and 2002 and search of references and relevant papers. Only clinical research studies on primary or secondary prevention of cardiovascular events in patients at high risk for coronary artery disease or patients experiencing unstable angina or myocardial infarction were included. Despite daily aspirin treatment, many patients break through aspirin treatment and experience cardiovascular events. Individuals at high risk for coronary disease or with established disease benefit from combination therapy with aspirin plus warfarin, if compliance with warfarin is greater than 70% and the target international normalized ratio (INR) of 2.0-2.5 is achieved. Combination therapy within these parameters leads to a 29-45% reduction in the risk of death, reinfarction and/or ischemic stroke. There is a significant increase in the rate of minor and a slight increase in the rate of major bleeding with combination therapy. Other potential indications for combination therapy include myocardial infarction associated with acute left ventricular aneurysm or significant left ventricular systolic dysfunction. In spite of reluctance to use oral anticoagulants, several large, randomized clinical trials support combination therapy with aspirin plus warfarin (INR, 2.0-2.5) in high-risk patients with atherosclerotic heart disease. Combination therapy increases the risk of minor and major bleeding, but not intracranial bleeding.
    The Journal of invasive cardiology 06/2004; 16(5):271-8. · 1.57 Impact Factor
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    ABSTRACT: Acute ST-segment elevation myocardial infarction continues to be associated with substantial mortality rates. Despite much advancement in care, current treatments have also failed to eliminate the significant risk of morbidity, including reinfarction, reocclusion of the infarct-related artery, and thromboembolic stroke. The potential benefit of early thrombolytic therapy in reducing mortality was first established in 1986. Further benefits of conjunctive therapy with aspirin were demonstrated soon thereafter. This review examines the most significant trends in the pharmacologic therapy of ST-segment elevation myocardial infarction since the publication of these early studies: the development of fibrinolytic drugs with improved clot selectivity and improved pharmacokinetic profiles that simplify administration, making ED or even prehospital thrombolysis more practical. More recent data can be interpreted as showing that regimens that are simpler and easier to administer are also clinically superior. This article reviews pharmacologic advances and evaluates the evidence for their use in EDs.
    American Journal of Emergency Medicine 02/2004; 22(1):14-23. · 1.70 Impact Factor
  • Journal of The American College of Cardiology - J AMER COLL CARDIOL. 01/2004; 43(5).
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    Journal of The American College of Cardiology - J AMER COLL CARDIOL. 01/2004; 43(5).
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    ABSTRACT: The aim of this study was to determine whether discontinuation of low-molecular-weight heparin (LMWH) treatment results in a clustering of cardiac ischemic events as previously observed after cessation of unfractionated heparin (UFH) in acute coronary syndrome (ACS) patients. Clinical trials in patients with ACS have shown early recurrent ischemic events after discontinuation of UFH treatment. We analyzed whether LMWH cessation also results in early ischemic recurrence events and if continuation of a fixed-dose LMWH prevents this complication. The combined incidence of death, myocardial infarction, or urgent revascularization in the first seven days after discontinuation of UFH (n = 3,012), short-term enoxaparin 1 mg/kg subcutaneously twice a day (n = 2,011), and short-term enoxaparin followed by prolonged enoxaparin 60 mg subcutaneously twice a day (n = 1,075) was analyzed from the combined Thrombolysis In Myocardial Infarction (TIMI) 11B/Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events (ESSENCE) database in a per patient analysis. The cessation of both UFH and short-term enoxaparin resulted in a similar clustering of recurrent ischemic events on the first day, with an incidence of the primary end point of 2.8% in both groups. Of all recurrent events in the first week after cessation, 40% occurred in the first 24 h. The continuation of a fixed-dose enoxaparin treatment prevented this early excess, with a first day incidence of 0.4% (p < 0.0001). The TIMI risk score characteristics predicted the incidence of early rebound ischemic events. There is significant clustering of recurrent ischemic events within 24 h after cessation of both short-term UFH and enoxaparin treatment, and patients should be carefully monitored during that period. This early rebound may be prevented by continuation of a fixed dose of enoxaparin.
    Journal of the American College of Cardiology 12/2003; 42(12):2083-9. · 14.09 Impact Factor
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    ABSTRACT: In high-risk patients with acute coronary syndromes (ACS), there have been concerns relating to the safety of using low molecular weight heparins (LMWH) in combination with a glycoprotein (GP) IIb/IIIa antagonist, and the continued use of LMWH in patients brought to the cardiac catheterization laboratory for percutaneous coronary intervention (PCI). The National Investigators Collaborating on Enoxaparin-3 (NICE-3) study was an open-label observational study of enoxaparin in combination with any 1 of 3 available GP IIb/IIIa antagonists in patients presenting with non-ST-elevation ACS. The primary end point was the incidence of major bleeding not related to coronary artery bypass graft (CABG) surgery. Data were also recorded on the incidence of death, myocardial infarction (MI), and urgent revascularization for repeat ischemia. A total of 671 patients with validated data were treated with enoxaparin; 628 of these patients also received a GP IIb/IIIa antagonist (tirofiban, n = 229; eptifibatide, n = 272; abciximab, n = 127); 283 of 628 underwent percutaneous coronary intervention (PCI). The 30-day incidence of non-CABG major bleeding was 1.9%, and was not significantly higher than a prespecified historical control rate of 2.0%. Outcome events included death (1.0% at hospital discharge and 1.6% at 30 days), MI (3.5% and 5.1%, respectively), and urgent revascularization (2.7% and 6.8%, respectively). The safety of enoxaparin plus a GP IIb/IIIa antagonist was comparable to that of unfractionated heparin plus a GP IIb/IIIa antagonist, as reported in other recent major trials. Patients undergoing PCI can be safely managed with enoxaparin and a GP IIb/IIIa antagonist, without supplemental use of unfractionated heparin.
    American heart journal 11/2003; 146(4):628-34. · 4.65 Impact Factor
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    ABSTRACT: The aims of the Safety and Efficacy of Subcutaneous Enoxaparin Versus Intravenous Unfractionated Heparin and Tirofiban Versus Placebo in the Treatment of Acute ST-Segment Elevation Myocardial Infarction Patients Ineligible for Reperfusion (TETAMI) study were to demonstrate that enoxaparin was superior to unfractionated heparin (UFH) and that tirofiban was better than placebo in patients with acute ST-segment elevation myocardial infarction (STEMI) who do not receive timely reperfusion. An optimal treatment strategy has not been identified for the many STEMI patients ineligible for acute reperfusion. A total of 1224 patients were enrolled in 91 centers in 14 countries between July 1999 and July 2002. Patients with STEMI ineligible for reperfusion were randomized to enoxaparin, enoxaparin plus tirofiban, UFH, or UFH plus tirofiban. All patients received oral aspirin. The primary efficacy end point was the 30-day combined incidence of death, reinfarction, or recurrent angina; the primary analysis was the comparison of the pooled enoxaparin and UFH groups. REULTS: The incidence of the primary efficacy end point was 15.7% enoxaparin versus 17.3% for UFH (odds ratio 0.89 [95% confidence interval CI = 0.66 to 1.21]) and 16.6% for tirofiban versus 16.4% for placebo (odds ratio 1.02 [95% CI 0.75 to 1.38]). The Thrombolysis In Myocardial Infarction (TIMI) major hemorrhage rate was 1.5% for enoxaparin versus 1.3% for UFH (odds ratio 1.16 [95% CI 0.44 to 3.02]) and 1.8% versus 1% for tirofiban versus placebo (odds ratio 1.82 [95% CI 0.67 to 4.95]). This study did not show that enoxaparin significantly reduced the 30-day incidence of death, reinfarction, and recurrent angina compared with UFH in non-reperfused STEMI patients. However, enoxaparin appears to have a similar safety and efficacy profile to UFH and may be an alternative treatment. Additional therapy with tirofiban did not appear beneficial.
    Journal of the American College of Cardiology 11/2003; 42(8):1348-56. · 14.09 Impact Factor
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    ABSTRACT: BACKGROUND: Treatment with lytics or primary percutaneous coronary interventions (PCI) reduces the mortality rate of patients with ST-elevation myocardial infarction (STEMI) presenting within 12 hours. Patients presenting >12 hours are generally considered to be ineligible for reperfusion therapy, and there are currently no specific treatment recommendations for this subgroup.Methods- All patients with STEMI <24 hours were included in the Treatment with Enoxaparin and Tirofiban in Acute Myocardial Infarction (TETAMI) randomized trial or registry. Those patients who were ineligible for acute reperfusion, had no cardiogenic shock, and were not planned for revascularization within 48 hours were randomized to 1 of 4 antithrombotic regimens involving enoxaparin or unfractionated heparin (UFH), in combination with tirofiban or placebo for 2 to 8 days. A concurrent registry tracked STEMI patients coming in within <12 hours, and who underwent reperfusion. This registry also tracked the remaining STEMI patients who neither received reperfusion nor were enrolled in the TETAMI randomized trial. The demographics and clinical outcomes of all three groups (received reperfusion therapy, too late for reperfusion and enrolled in the randomized trial, neither received reperfusion therapy nor were enrolled in the randomized trial) were prospectively tracked. RESULTS AND CONCLUSIONS: There were 2,737 patients who presented with STEMI or a new left branch bundle block (LBBB), of which 1,654 (60%) presented < or =12 hours. There were 1,196 (72%) of 1,654 patients who received reperfusion therapy. There were 458 (28%) of the 1,654 patients deemed "ineligible" for reperfusion, mostly because of a contraindication to lytics or for being "too old." In contrast, 1,083 (40%) of 2,737 patients presented >12 hours. Apart from 34 of these patients who had a stuttering infarction and were referred for reperfusion, the remaining patients did not receive reperfusion therapy. Registry patients who received reperfusion therapy, compared with TETAMI randomized patients (all of whom received antithrombotic therapy) and registry patients who did not receive reperfusion, were younger (61 years versus 63 years and 67 years), were more likely to be male (78% versus 73% and 63%), and had persistent ST-segment elevation as opposed to LBBB or Q waves. Registry patients who received reperfusion therapy had better clinical outcomes, even after adjusting for admission Killip class, compared with TETAMI randomized patients and registry patients who did not receive reperfusion therapy. TETAMI randomized patients had better outcomes than registry patients who did not receive reperfusion therapy. The major obstacle to expanding the delivery of reperfusion therapy to patients with STEMI is the large fraction of patients who present too late for reperfusion therapy. Examination of prospectively gathered data on STEMI patients who are ineligible for reperfusion may help optimize their treatment.
    Circulation 10/2003; 108(16 Suppl 1):III14-21. · 15.20 Impact Factor
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    ABSTRACT: To examine differences in patient characteristics and outcomes in 19636 patients enrolled in the USA and 3027 patients enrolled in other countries undergoing intra-aortic balloon pump (IABP) counterpulsation. Indications for IABP use; a larger percentage of US patients were identified as 'early support and stabilization for angiography or angioplasty' (21.1% US vs 11.8% non-US), and 'pre-operative support for high-risk CABG' (15.9% vs 6.6%). A smaller percentage of US patients vs non-US patients were identified as 'weaning from cardiopulmonary bypass' (14.3% vs 28.2%), and 'refractory ventricular failure' (6.2% vs 9.8%). One out of five patients in both groups was listed as 'cardiogenic shock' (18.9% US vs 20.2% non-US). All cause, risk-adjusted, in-hospital mortality (20.1% vs 28.7%; P<0.001), and mortality with IABP in place (10.8% vs 18.0%; P<0.001) were lower at US vs non-US sites. In both US and non-US institutions, IABP associated complication rates, such as IABP-related mortality (0.05% vs 0.07%), major limb ischaemia (0.9% vs 0.8%), and severe bleeding (0.9% vs 0.8%), were low. IABP counterpulsation is deployed at an earlier clinical stage in US patients. Mortality rates are higher for non-US patients, particularly for patients with non-surgery cardiac interventions, even after adjusting for risk factors. Complication rates were low. Physicians should therefore not be reluctant to use IABP in high-risk patients undergoing cardiac procedures.
    European Heart Journal 10/2003; 24(19):1763-70. · 14.10 Impact Factor

Publication Stats

3k Citations
836.33 Total Impact Points


  • 2003–2014
    • Beth Israel Medical Center
      • • Department of Medicine
      • • Cardiac Catheterization Lab
      New York City, New York, United States
    • Philadelphia University
      Philadelphia, Pennsylvania, United States
    • The Children's Hospital of Philadelphia
      Philadelphia, Pennsylvania, United States
    • Philadelphia College of Pharmacy and Science
      Philadelphia, Pennsylvania, United States
    • Academisch Medisch Centrum Universiteit van Amsterdam
      • Department of Cardiology and Cardio-thoracic Surgery
      Amsterdam, North Holland, Netherlands
    • Cardiovascular Research Foundation
      New York City, New York, United States
  • 2007–2013
    • Beth Israel Deaconess Medical Center
      • Department of Medicine
      Boston, Massachusetts, United States
  • 2012
    • Institut Universitaire de France
      Lutetia Parisorum, Île-de-France, France
  • 2004–2011
    • Duke University Medical Center
      • Duke Clinical Research Institute
      Durham, NC, United States
  • 2006–2010
    • Hôpital La Pitié Salpêtrière (Groupe Hospitalier "La Pitié Salpêtrière - Charles Foix")
      Lutetia Parisorum, Île-de-France, France
    • University of Toronto
      • Division of Cardiology
      Toronto, Ontario, Canada
  • 2009
    • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
      San Paulo, São Paulo, Brazil
    • Harvard Medical School
      Boston, Massachusetts, United States
    • University of the Sciences in Philadelphia
      • Department of Pharmacy Practice and Pharmacy Administration
      Philadelphia, PA, United States
  • 2006–2009
    • Auckland City Hospital
      Окленд, Auckland, New Zealand
  • 2008
    • University of Kentucky
      Lexington, Kentucky, United States
    • Icahn School of Medicine at Mount Sinai
      Manhattan, New York, United States
  • 2000–2007
    • Brigham and Women's Hospital
      • • Department of Medicine
      • • Center for Brain Mind Medicine
      Boston, MA, United States
    • University of Vienna
      Wien, Vienna, Austria
  • 2002
    • Hospital of the University of Pennsylvania
      Philadelphia, Pennsylvania, United States
    • Partners HealthCare
      Boston, Massachusetts, United States
    • The University of Edinburgh
      Edinburgh, Scotland, United Kingdom
    • Tenet HealthSystem Medical, Inc.
      Dallas, Texas, United States