American Heart Association, 2006 Scientific Sessions: Clopidogrel Plus Aspirin Benefits Patients at Higher Risk for Cardiovascular Disease

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Speaker: Keith A. Fox, MD, Professor of Cardiology, and Head of Medical and Radiological Services, Department of Cardiological Research, University of Edinburgh, Edinburgh, United Kingdom

The impact of risk status, prior history, and proximity to recent cardiovascular events such as a myocardial infarction (MI) or stroke plays a major role in the efficacy of clopidogrel (Plavix medication, Sanofi-Aventis) when added to aspirin therapy in patients with symptomatic coronary artery disease, cardiovascular disease, peripheral artery disease, or a history of cardiovascular (CV) events.

In the CHARISMA study (Clopidogrel for High Atherosclerosis Risk and Ischemic Stabilization, Management, and Avoidance), 15,603 patients were treated with aspirin. They were then randomly assigned to receive clopidogrel or placebo over a median of 28 months. The primary endpoint was cardiovascular death, MI, or stroke.

The initial results showed a nonsignificant trend favoring canadian clopidogrel in 6.8% of treated patients, compared with 7.3% of placebo patients. The data were then further analyzed to see whether patients’ risk status at baseline and their proximity to a resulting CV event influenced their response to long-term dual antiplatelet therapy.

The incidence of CV death, MI, and stroke was 7% with clopidogrel patients and 7.8% with placebo. These findings were consistent with those of the trial’s primary endpoint.

When CV outcomes were assessed according to quartiles of baseline CV risk, only in the quartile with the greatest CV risk did a strong trend exist for a reduced risk of CV events with the addition of clopidogrel to aspirin.

When clopidogrel treatment was begun within six months after a stroke or MI, the benefit of clopidogrel therapy had a significant effect on the rate of future death, MI, or stroke. In patients with a documented prior vascular event or with confirmed peripheral arterial disease, the risk of death, MI, or stroke was 7.3% with clopidogrel therapy versus 8.8% with placebo.

Effects of Bivalirudin in Elderly Patients with Non-STE Acute Coronary Syndrome

Speaker: E. Magnus Ohman, MD, Professor of Medicine, and Director of the Program for Advanced Coronary Disease Cardiac Catheterization and Angioplasty, Duke University Medical Center, Durham, North Carolina

Elderly patients (65 years of age and older) with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) had similar outcomes for ischemia, lower rates of non-coronary artery bypass graft (CABG) surgery and bleeding, and similar clinical outcomes at 30 days with bivalirudin (Angiomax, The Medicines Company), compared with glycoprotein IIb/IIIa inhibitors (GPI) plus heparin or low-molecular-weight heparin (LMWH). These results also applied to younger patients. The findings were reported after further assessment of results from the Acute Catheterization and Urgent intervention Triage studF (ACUITY) trial.

According to the initial results of the ACUITY trial, monotherapy with bivalirudin produced superior clinical outcomes, compared with heparin, whether unfractionated or LMWH (enoxa-parin [Lovenox, Sanofi-Aventis]) plus a GPI in patients with either moderate or higher-risk NSTE-ACS who were managed with an early invasive strategy. Because older patients with NSTE-ACS are at high risk for ischemic cardiac events and bleeding complications associated with current antithrombotic regimens, an analysis of the data was performed to explore outcomes in this population in the ACUITY trial.
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Of the 13,819 patients enrolled in the study (range, 20 to 95 years of age), 45% of the patients (n = 6,224) were older than age 65 and 17.7% (n = 2,441) were 75 years of age or older. The assessment included composite ischemic events (death, MI, unplanned revascularization), or non-CABG major bleeding and the net clinical outcome (death, MI, unplanned revascu-larization, or non-CABG major bleeding) at 30 days in four age groups: younger than age 55, age 55 to 65, age 65 to 75, and older than age 75.

The analysis was limited to patients randomly receiving bivalirudin monotherapy compared with those receiving heparin or LMWH with GPI (only for percutaneous coronary intervention).

In the prespecified subgroup of those 65 years of age or older, the composite incidence of ischemic outcomes, major non-CABG bleeding, and net clinical benefit with bivalirudin monotherapy was 9.5%; for heparin or LMWH plus GPI, the figure was 8.9%.

In the patients younger than age 65, the composite incidence of ischemic outcomes, major non-CABG bleeding, and net clinical benefit with bivalirudin alone was 4.4%; for heparin or LMWH plus GPI, this figure was 7.8%.

When age-specific outcomes were assessed separately, the net clinical outcomes in all four age groups were comparable, as were composite ischemic outcomes between bivalirudin monotherapy and heparin or LMWH plus GPI. online pharmacy prescription drugs

As for non-CABG bleeding, patients in each of the four age groups who received bivalirudin alone experienced significantly less major bleeding than patients receiving heparin or

LMWH plus GPI.