Speaker: Zhengming Chen, MD, Reader in Epidemiology, Oxford University, and Member of the Clinical Trial Service Unit, Radcliffe Infirmary, Oxford, United Kingdom

Adding clopidogrel (Sanofi-Aventis/Bristol-Myers Squibb) to aspirin as well as standard medical therapy was beneficial, compared with aspirin and standard medical therapy alone, in reducing the risk of death and nonfatal vascular events in patients with acute ST-elevation myocardial infarction (MI).

The COMMIT-CC2 (ClOpidogrel and Metoprolol in Myocardial Infarction Trial-Second Chinese Cardiac) Study is one of the largest randomized, double-blind, placebo-controlled trials of drug therapy ever performed for heart disease. The study, conducted at 1,250 centers across China, enrolled 45,852 patients with ST-elevation myocardial infarction (MI) who were seen by a physician within 24 hours of symptom onset.

The patients were randomly assigned to receive day or placebo for up to four weeks, along with aspirin 162 mg/day, plus fibrinolytic therapy. This regimen was given to 50% of the patients, and anticoagulants were given to 74%. The patients also received standard medical therapy, such as angiotensin-converting enzyme (ACE)-inhibitors, nitrates, antiarrhythmic agents, diuretics, calcium-channel blockers.

The primary endpoints were all-cause mortality and the composite endpoint of death, stroke, or current MI at the end of four weeks in the hospital or before discharge. The mean duration of treatment and follow-up lasted just over two weeks. The primary endpoint of all-cause mortality at hospital discharge was significantly lower with clopidogrel; 1,728 (7.7%) of the treated patients died, and 1,846 (8.1%) of the placebo patients died. A risk reduction of 7% favored clopidogrel.

In the co-primary composite endpoint of death, re-infarction, or stroke, adding clopidogrel to aspirin and standard therapy produced a significant 9% reduction in risk, compared with placebo. There were 2,125 events (9.3%) with canadian clopidogrel and 2,311 events (10.1%) with placebo. The risk of re-infarction also was lower with clopidogrel than with placebo, but the incidence of stroke did not differ between the two patient groups.

There was no significant risk of hemorrhage or other major bleeding episodes in either patient group.

It is estimated that the addition of clopidogrel could potentially save 5,000 lives and prevent another 5,000 nonfatal major vascular events.

Enoxaparin for Acute Coronary Syndrome

Speaker: Marc Cohen, MD, Professor of Medicine, Mount Sinai School of Medicine, and Director, Division of Cardiology, Newark Beth Israel Medical Center, Newark, New Jersey

In the recent Superior Yield of the New Strategy of Enoxa-parin Revascularization and Glycoprotein IIb/IIIa Inhibitors (SYNERGY) trial, 76% of patients with non-ST-segment elevation acute coronary syndrome were given antithrombin therapy before being randomly assigned to take enoxaparin (Lovenox®, Sanofi-Aventis) or unfractionated heparin (UFH). Of the 9,978 patients, 2,440 did not receive pre-randomization therapy and 6,138 received consistent therapy. The primary efficacy outcomes were (1) the composite of mortality or nonfatal MI during the first 30 days after randomization and (2) the incidence of severe bleeding.
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In the subgroup receiving no prior treatment, the primary outcome occurred in 12.6% of the enoxaparin patients and in 14.8% of the UFH patients. In the subgroup of patients receiving no prior antithrombin therapy or those assigned to take the same antithrombin agent as before enrollment, the primary endpoint occurred in 13.3% of the enoxaparin patients and in 15.9% of the UFH patients. The rates of major or severe bleeding were slightly higher in the former group than in the latter.

After the investigators adjusted for differences in baseline characteristics between pretreatment subgroups, the patients who had not received any previous antithrombin therapy had significantly better efficacy outcomes when the initial therapy was enoxaparin but not UFH.