Background Despite current treatments, patients who have acutecoronary syndromes without ST-segment elevation have high ratesof major vascular events. We evaluated the efficacy and safetyof the antiplatelet agent clopidogrel when given with aspirinin such patients.
Methods We randomly assigned 12,562 patients who had presentedwithin 24 hours after the onset of symptoms to receive clopidogrel(300 mg immediately, followed by 75 mg once daily) (6259 patients)or placebo (6303 patients) in addition to aspirin for 3 to 12months.
Results The first primary outcome — a composite of deathfrom cardiovascular causes, nonfatal myocardial infarction,or stroke — occurred in 9.3 percent of the patients inthe clopidogrel group and 11.4 percent of the patients in theplacebo group (relative risk with clopidogrel as compared withplacebo, 0.80; 95 percent confidence interval, 0.72 to 0.90;P<0.001). The second primary outcome — the first primaryoutcome or refractory ischemia — occurred in 16.5 percentof the patients in the clopidogrel group and 18.8 percent ofthe patients in the placebo group (relative risk, 0.86, P<0.001).The percentages of patients with in-hospital refractory or severeischemia, heart failure, and revascularization procedures werealso significantly lower with clopidogrel. There were significantlymore patients with major bleeding in the clopidogrel group thanin the placebo group (3.7 percent vs. 2.7 percent; relativerisk, 1.38; P=0.001), but there were not significantly morepatients with episodes of life-threatening bleeding (2.1 percentvs. 1.8 percent, P=0.13) or hemorrhagic strokes.
Conclusions The antiplatelet agent clopidogrel has beneficialeffects in patients with acute coronary syndromes without ST-segmentelevation. However, the risk of major bleeding is increasedamong patients treated with clopidogrel.
Source Information
The Manuscript Writing Committee (Salim Yusuf, D.Phil., F.R.C.P.C., Feng Zhao, M.Sc., Shamir R. Mehta, M.D., F.R.C.P.C., Susan Chrolavicius, B.Sc., Gianni Tognoni, M.D., and Keith K. Fox, M.D., F.R.C.P.) assumes responsibility for the overall content of the manuscript.
Address reprint requests to Dr. Yusuf at the Canadian Cardiovascular Collaboration Project Office, Population Health Research Institute, McMaster University, Hamilton General Hospital, 237 Barton St. E., Hamilton, ON L8L 2X2, Canada, or at yusufs{at}mcmaster.ca.
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(2007). Emergent Combined Intracranial Thrombolysis and Carotid Stenting in the Hyperacute Management of Stroke Patients with Severe Cervical Carotid Stenosis. Am. J. Neuroradiol.
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[Abstract][Full Text]
A correction has been published: N Engl J Med 2001;345(20):1506.
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