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Marc Cohen

Publications and source records attributed to Marc Cohen.

At least 55 records · Page 3Linked to original sources
PubMed2003

Combining enoxaparin and glycoprotein IIb/IIIa antagonists for the treatment of acute coronary syndromes: final results of the National Investigators Collaborating on Enoxaparin-3 (NICE-3) study.

BACKGROUND: 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). METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Abciximab↗
PubMed2003

A randomized, double blind, placebo controlled trial of a topical cream containing glucosamine sulfate, chondroitin sulfate, and camphor for osteoarthritis of the knee.

OBJECTIVE: To assess the ability of a topical preparation of glucosamine sulfate and chondroitin sulfate to reduce pain related to osteoarthritis (OA) of the knee. METHODS: Sixty-three patients were randomized to receive either a topical glucosamine and chondroitin preparation or placebo to be used as required over an 8 week period. Efficacy was assessed using a visual analog scale (VAS) for pain as well as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the SF-36 questionnaire. RESULTS: VAS scores indicated a greater mean reduction in pain for the glucosamine/chondroitin preparation group (mean change -3.4 cm, SD 2.6 cm) compared to the placebo group (mean change -1.6 cm, SD 2.7 cm) after 8 weeks. After 4 weeks the difference between active and placebo groups in their mean reduction from baseline was 1.2 (95% CI 0.1 to 2.4, p = 0.03) and after 8 weeks was 1.8 (95% CI for difference between groups, 0.6 to 2.9 cm; p = 0.002). CONCLUSION: Topical application of glucosamine and chondroitin sulfate is effective in relieving the pain from OA of the knee and improvement is evident within 4 weeks.

Administration, Topical↗
PubMed2003

Platelets and antiplatelet therapy in patients with diabetes mellitus.

Atherosclerotic heart disease is the leading cause of death in patients with diabetes mellitus. Platelets play a major role in the clinical manifestations of ischemic heart disease. Diabetic patients have hyperreactive platelets with exaggerated adhesion, aggregation and thrombin generation. Antiplatelet agents, including aspirin, clopidogrel, and glycoprotein IIb/IIIa inhibitors, have shown significant efficacy in reducing recurrent ischemic events in patients with diabetes. Treatment with glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention reduces mortality in diabetic patients.

Blood Platelets↗
PubMed2002

Comparison of enoxaparin versus unfractionated heparin in patients with unstable angina pectoris/non-ST-segment elevation acute myocardial infarction having subsequent percutaneous coronary intervention.

Patients with unstable angina or non-ST-segment elevation myocardial infarction (MI) may undergo invasive revascularization procedures shortly after admission to hospital or after a brief period of stabilization. In the Thrombolysis In Myocardial Infarction (TIMI) 11B trial and Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events (ESSENCE) trial 1,326 patients underwent percutaneous coronary intervention (PCI). A total of 924 patients underwent PCI during the initial hospitalization period, and of these, 445 patients did so while receiving treatment with unfractionated heparin (UFH) or the low-molecular-weight heparin, enoxaparin. This analysis compared efficacy and clinical events in the enoxaparin and UFH groups in patients who: (1) underwent PCI while on treatment versus those who did not, and (2) underwent PCI in hospital. We also compared those who did not undergo PCI. Treatment with enoxaparin (1 mg/kg given as twice daily subcutaneous injections) was beneficial and well tolerated in patients with unstable angina and non-ST-segment elevation MI who underwent PCI. Compared with UFH, enoxaparin significantly reduced the likelihood of clinical events (death and nonfatal MI after PCI) in patients who underwent PCI after 1 year (p = 0.003 for in-hospital PCI; p = 0.005 for on-treatment PCI), with a trend toward a reduced event rate at 43 days. In addition, patients treated with enoxaparin who did not undergo PCI also showed a reduction in the risk of death, nonfatal MI, and urgent revascularization when compared with those treated with UFH (significant at 43 days, with a trend persisting at 1 year). Study limitations were that PCI was nonrandomized, the analysis was post hoc, and the sample size was relatively small. Nevertheless, in the absence of large clinical trials, this study suggests that treatment with enoxaparin was well tolerated, and exhibited a similar risk of major hemorrhage to UFH in patients who underwent PCI.

Angina, Unstable↗
PubMed2002

Impact of clinical syndrome acuity on the differential response to 2 glycoprotein IIb/IIIa inhibitors in patients undergoing coronary stenting: the TARGET Trial.

BACKGROUND: Although glycoprotein IIb/IIIa inhibitors have been shown to reduce periprocedural and late ischemic events in patients undergoing stent implantation, the relative safety and efficacy of different agents in this class is less established. Also unknown is whether the acuity of the presenting clinical syndrome, which may affect the degree of platelet inhibition required or achieved, influences the response to different antiplatelet agents. METHODS AND RESULTS: A prospective, multicenter, double-blind, randomized trial was performed in which 4809 patients undergoing planned stenting were randomized to receive abciximab or tirofiban. In patients with acute coronary syndromes (ACS; n=3025), abciximab resulted in lower rates of myocardial infarction at 30 days (5.8% versus 8.5%; P=0.004) and 6 months (7.2% versus 9.8%; P=0.013), although 6-month mortality rates were identical (1.39% in both groups; P=0.99). Conversely, in patients without ACS (n=1784), myocardial infarction rates were not significantly lower with tirofiban, survival was similar, and target vessel revascularization was reduced, which translated into a trend toward enhanced 6-month event-free survival with tirofiban (89.7% versus 86.6%; P=0.056). CONCLUSIONS: In patients with ACS undergoing stent implantation, abciximab use compared with tirofiban results in greater suppression of periprocedural myonecrosis, although a survival benefit has not been demonstrated. Patients with stable coronary syndromes may have equivalent or better outcomes with tirofiban relative to abciximab, with fewer adverse hematologic and hemorrhagic events. These data raise important issues regarding the relative pharmacodynamic inhibition of platelet function required in varying clinical scenarios and have important implications for the cost-effective utilization of glycoprotein IIb/IIIa inhibitors.

Abciximab↗
PubMed2002

Comparison of outcomes after 8 vs. 9.5 French size intra-aortic balloon counterpulsation catheters based on 9,332 patients in the prospective Benchmark registry.

The Benchmark intra-aortic balloon counterpulsation (IABC) registry maintains prospectively gathered clinical information on a large cohort of IABC patients. The purpose of the present report is to compare in-hospital outcomes and complications in patients treated with the newer 8 vs. 9.5 Fr size catheters. Between January 1997 and August 2000, data on 7,078 9.5 Fr and 2,254 8 Fr IABC insertions were submitted to Benchmark. This was not a randomized comparison but rather a posthoc analysis of prospectively gathered data. There was less limb ischemia with the 8 Fr IABC size catheter. There were no significant differences in bleeding or mortality between the two groups. Smaller IABC catheter size is associated with significantly less limb ischemia, especially in higher-risk patients. The large, population-based, ongoing Benchmark registry provides a useful vehicle for outcomes research concerning the evolving practice of IABC.

Aged↗
PubMed2002

Argatroban anticoagulation during percutaneous coronary intervention in patients with heparin-induced thrombocytopenia.

Heparin-induced thrombocytopenia (HIT) is an immune-mediated syndrome associated with thrombosis. Alternative anticoagulation to heparin is needed for HIT patients during percutaneous coronary intervention (PCI). We evaluated argatroban, a direct thrombin inhibitor, for anticoagulation in this setting. Ninety-one HIT patients underwent 112 PCIs while on intravenous argatroban (25 microg/kg/min [350 microg/kg initial bolus], adjusted to achieve an activated clotting time of 300-450 sec). Primary efficacy endpoints were subjective assessments of the satisfactory outcome of the procedure and adequate anticoagulation during PCI. Among patients undergoing initial PCIs with argatroban (n = 91), 94.5% had a satisfactory outcome of the procedure and 97.8% achieved adequate anticoagulation. Death (zero patients), myocardial infarction (four patients), or revascularization (four patients) at 24 hr after PCI occurred in seven (7.7%) patients overall. One patient (1.1%) experienced periprocedural major bleeding. For patients who had subsequent hospitalizations (mean separation of 150 days) for repeat PCI using argatroban anticoagulation (n = 21), there were no unsatisfactory outcomes. Overall, outcomes were comparable with those historically reported for heparin. Argatroban therefore is a reasonable anticoagulant option in this setting, where current options are limited.

Adult↗
PubMed2002

Impact of intra-aortic balloon counterpulsation with different balloon volumes on cardiac performance in humans.

Intra-aortic balloon (IAB) counterpulsation can augment the cardiac output. However, the effect of different IAB volumes on cardiac performance has not been adequately evaluated in humans. Eighty-two patients (52 males [63%]; mean age, 65 +/- 12 years; mean body surface area [BSA], 1.8 +/- 0.2 m(2)) had IAB counterpulsation for cardiogenic shock, refractory angina, and preoperatively for high-risk cardiac surgery. Cardiac hemodynamics were prospectively studied during IAB with inflation volumes of 32 vs. 40 cc. Hemodynamic data collected included aortic pressure, pulmonary artery pressure, systemic and mixed venous oxygen saturations, and cardiac output (by Fick). Transthoracic echocardiography (TTE) was used to obtain both velocity time integrals (VTIs) and the area of the left ventricular outflow tract (LVOT). Left ventricular stroke volume was then calculated as LVOT area x VTI. Cardiac output (CO) determined by the Fick method and VTI did not differ significantly (P = NS) between the two inflation volumes (y = 0.002 + 0.97x). In a subgroup of 33 patients with BSA <or= 1.8 m(2), the CO (by VTI) was slightly lower with IAB inflation volume of 32 vs. 40 cc (P = 0.05). Overall, smaller IAB inflation volumes do not affect the hemodynamic improvement seen during IAB counterpulsation. However, in patients with smaller BSA, larger inflation volumes may further augment CO.

Aged↗
PubMed2002

Defining optimal therapy for the thrombolysis-ineligible patient.

Not all patients presenting with acute coronary syndrome (ACS) are able to receive reperfusion therapy. These include patients who present late (after 12 h) or who have bleeding diathesis. Studies have found a number of factors affect the decision to reperfuse. Other treatment options are needed for those patients with acute ST-elevation myocardial infarction (STEMI). Low-molecular weight heparin, such as enoxaparin, now offers these patients the opportunity for successful intervention. Several clinical trials have determined its superiority over unfractionated heparin as an adjunct during thrombolytic therapy. Currently, a trial is underway to determine the effect of enoxaparin in combination with tirofiban in patients with STEMI ineligible for reperfusion therapy. Blinded data for the entire patient cohort shows excellent efficacy and safety in these patients.

Acute Disease↗
PubMed2002

Unfractionated versus fractionated heparin for percutaneous coronary intervention.

Since the advent of percutaneous coronary intervention (PCI), intravenous unfractionated heparin has been the primary antithrombotic therapy to prevent periprocedural ischemic complications. As compared with unfractionated heparin, low molecular weight heparins (LMWHs) have a greater bioavailability and a more predictable therapeutic response. In several recent studies of patients undergoing PCI, LMWHs have been shown to be as safe and effective as unfractionated heparin; given their better pharmacokinetic profile and the lack of need for coagulation monitoring, they have the potential to replace unfractionated heparin during coronary interventions. This article reviews the current status of anticoagulation therapy with unfractionated heparin and LMWHs in the cardiac catheterization laboratory.

Angioplasty, Balloon, Coronary↗
PubMed2002

Trends in intraaortic balloon counterpulsation complications and outcomes in cardiac surgery.

BACKGROUND: As the proportion of high-risk patients for cardiac surgery increases, use of intraaortic balloon counterpulsation (IABC) has increased, especially in preoperative therapy. Although the efficacy and cost-effectiveness of IABC have been demonstrated, historically higher complication rates have dissuaded some practitioners from using IABC. METHODS: This report describes IABC use in cardiac surgery, examines trends in complications over time, and compares outcomes in preoperative versus postoperative use in a single prospective worldwide registry over the past 3 years. RESULTS: The frequency of IABC use appears to be increasing with time as the complication rates have dramatically fallen. The overall IABC-related complication rate was 6.5% (460/7,101), and the rate of major complications (requiring surgery or transfusion) was 2.1% (148/7,101). Hospital mortality was significantly lower in patients treated preoperatively with IABC compared with patients treated postoperatively (8.8% vs 28.2%, p < 0.0001), although this may be due to a selection bias in the postoperative group. CONCLUSIONS: Preoperative IABC therapy leads to better patient outcomes in high-risk CABG patients. Improved IABC technology and better surveillance have led to increased use with lower complication rates. Although selection bias is inherent in retrospective studies, the Benchmark Counterpulsation Outcomes Registry outcomes are in close concordance to prospective randomized studies previously reported.

Cardiac Surgical Procedures↗
PubMed2002

Mode and timing of treatment failure (recurrent ischemic events) after hospital admission for non-ST segment elevation acute coronary syndromes.

BACKGROUND: Clarification of the specific clinical course of non-ST-segment elevation acute coronary syndromes (NSTEMI ACS), including recurrent ischemic events and need for coronary revascularization, is important given the increasing economic pressure to shorten the length of hospitalization and therefore the duration of acute therapy. To examine the mode and timing of subsequent cardiac events, we analyzed pooled data from the ESSENCE and TIMI 11B studies of antithrombotic therapy in NSTEMI ACS. METHODS: The daily event rates (with confidence intervals) during the first 43 days and the monthly average event rates during the first year were tabulated for 7081 patients. RESULTS: The median antithrombotic treatment duration was 3.2 days, whereas the highest absolute frequency of recurrent angina prompting urgent revascularization, myocardial infarction, or death after hospital admission occurred on day 2, day 3, and day 8, respectively. Coronary revascularization was performed in 32% of patients, with the greatest number occurring on day 4. Only 12% of the end point events were adjudicated as being periprocedural. The median length of hospital stay was 7 days. CONCLUSIONS: Despite aggressive antithrombotic therapy, a significant proportion of patients with NSTEMI ACS have recurrent ischemia precipitating urgent revascularization or infarction within the first few days, whereas the highest risk of death occurs later, after the first week.

Angina Pectoris↗
PubMed2002

Identification of patients at high risk for death and cardiac ischemic events after hospital discharge.

BACKGROUND: Patients with unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) remain at risk for death and cardiac ischemic events after being discharged from the hospital. METHODS: We examined whether the Thrombolysis In Myocardial Infarction (TIMI) risk score for UA/NSTEMI, ascertained at presentation in patients enrolled in the TIMI 11B and Efficacy and Safety of Subcutaneous Enoxaparin in Unstable Angina and Non-Q-Wave MI (ESSENCE) trials, could be used to identify patients at high risk for major cardiac events after hospital discharge. RESULTS: There were a total of 1218 major cardiac events, defined as death, nonfatal myocardial infarction, or urgent revascularization, by day 43. Of these events, 336 (28%) occurred in patients after they were discharged from the hospital. Use of the TIMI risk score for UA/NSTEMI revealed a progressive, statistically significant increase in the rate of events after leaving the hospital as the patients' baseline level of risk increased (P <.001 for chi(2) test for trend). For patients with a risk score of 5 to 7, treatment with enoxaparin during the acute phase was associated with an odds ratio of 0.51 (95% CI 0.29-0.91) for the occurrence of death and cardiac ischemic events after hospital discharge. CONCLUSIONS: More than one fourth of the major cardiac events that will occur in the first 6 weeks occur after discharge from the hospital. Stratification at presentation on the basis of the TIMI risk score for UA/NSTEMI can be used to identify patients at high risk for these events. Among patients at high-risk, acute-phase treatment with enoxaparin significantly reduces the risk of major cardiac events after leaving the hospital.

Angina, Unstable↗
PubMed2002

Low-molecular-weight heparin therapy for non-ST-elevation acute coronary syndromes and during percutaneous coronary intervention: an expert consensus.

BACKGROUND: Therapy with either low-molecular-weight heparin (LMWH) or glycoprotein (GP) IIb/IIIa receptor antagonists is of benefit to patients with acute coronary syndromes (ACSs). However, algorithms that define how LMWH may be used in patients, proceeding from medical management to intervention and in conjunction with GP IIb/IIIa inhibitors, are lacking. The objectives of this task force were to formulate recommendations based on all available data for the use of LMWH, both with and without GP IIb/IIIa receptor antagonists, and to provide seamless integration of care during the transition from medical to interventional management. METHODS AND RESULTS: An international task force of 14 cardiologists with extensive experience in clinical trials was convened in New York in February 2001 to address issues related to the use of LMWH in patients with non-ST-elevation ACS. Evidence from randomized trials, observational studies, and other reports was discussed, and consensus recommendations were formulated. CONCLUSIONS: Substantial evidence exists that patients receiving LMWH for an ACS can safely undergo cardiac catheterization and percutaneous coronary intervention. Concerns regarding the transition of these patients from the medical service to the cardiac catheterization laboratory should therefore not impede the upstream use of LMWH. Furthermore, LMWH and GP IIb/IIIa receptor antagonists can be used safely in combination, with no apparent increase in the risk of major bleeding. Consensus algorithms for therapy are presented.

Acute Disease↗
PubMed2002

Randomized double-blind safety study of enoxaparin versus unfractionated heparin in patients with non-ST-segment elevation acute coronary syndromes treated with tirofiban and aspirin: the ACUTE II study. The Antithrombotic Combination Using Tirofiban and Enoxaparin.

BACKGROUND: In comparison with treatment with unfractionated heparin (UFH) and aspirin (ASA), both tirofiban administered with UFH and ASA, and enoxaparin plus ASA have shown superiority in reducing cardiac ischemic events in patients with unstable angina and non-ST-segment elevation myocardial infarction. Replacing UFH with enoxaparin when tirofiban is administered to patients may offer further therapeutic benefit, but could also increase bleeding. OBJECTIVE: Our objective was to provide estimates of the frequency of bleeding complications, as defined by means of the Thrombolysis In Myocardial Infarction(TIMI) group, and collect data on clinical efficacy of the combination of tirofiban with enoxaparin plus ASA. METHODS: Five hundred twenty-five patients with UA/NSTEMI were treated with tirofiban coadministered with ASA and randomized to receive either UFH (n = 210) or enoxaparin (n = 315). Therapy was administered for 24 to 96 hours. Bleeding incidences were assessed until 24 hours after trial therapy was discontinued; other clinical outcomes were assessed for as long as 30 days. RESULTS: The total bleeding rate (TIMI major + minor + loss-no-site) for the UFH group versus the enoxaparin group was 4.8% vs 3.5% (odds ratio [OR] 1.4, CI 0.6-3.4). The TIMI major and minor bleeding rates for the UFH versus the enoxaparin groups were 1.0% versus 0.3% (OR 3.0, CI 0.3-33.8) and 4.3% versus 2.5% (OR 1.7, CI 0.7-4.6). There was an increase in nuisance cutaneous and oral bleeds (<50 mL of blood loss) in the enoxaparin group. Death or myocardial infarction occurred with similar frequency in the 2 groups (9.0% vs 9.2%). However, refractory ischemia requiring urgent revascularization and rehospitalization because of unstable angina occurred more frequently in the UFH group (4.3% vs 0.6% and 7.1% vs 1.6%, respectively). CONCLUSIONS: Combination therapy with tirofiban plus enoxaparin appears safe, relative to therapy with tirofiban plus UFH.

Adult↗
PubMed2002

Polymerized bovine hemoglobin solution as a replacement for allogeneic red blood cell transfusion after cardiac surgery: results of a randomized, double-blind trial.

BACKGROUND: Blood loss leading to reduced oxygen-carrying capacity is usually treated with red blood cell transfusions. This study examined the hypothesis that a hemoglobin-based oxygen-carrying solution can serve as an initial alternative to red blood cell transfusion. METHODS: In a randomized, double-blind efficacy trial of HBOC-201, a total of 98 patients undergoing cardiac surgery and requiring transfusion were randomly assigned to receive either red blood cell units or HBOC-201 (Hemopure; Biopure Corporation, Cambridge, Mass) for the first three postoperative transfusions. Patients were monitored before and after transfusion, at discharge, and at 3 to 4 weeks after the operation for subsequent red blood cell use, hemodynamics, and clinical laboratory parameters. RESULTS: The use of HBOC-201 eliminated the need for red blood cell transfusions in 34% of cases (95% confidence interval 21%-49%). Patients in the HBOC group received a mean of 1.72 subsequent units of red blood cells; those who received red blood cells only received a mean of 2.19 subsequent units (P =.05). Hematocrit values were transiently lower in the HBOC group but were similar in the two groups at discharge and follow-up. Oxygen extraction was greater in the HBOC group (P =.05). Mean increases in blood pressure were greater in the HBOC group, but not significantly so. CONCLUSION: HBOC-201 may be an initial alternative to red blood cell transfusions for patients with moderate anemia after cardiac surgery. In a third of cases, HBOC-201 eliminated the need for red blood cell transfusion, although substantial doses were needed to produce this modest degree of blood conservation.

Aged↗