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In the Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events (ACTIVE)-A, 7,554 patients with documented AF and with at least 1 risk factor for stroke were randomized to receive aspirin 75 to 100 mg/d alone or in addition to clopidogrel 75 mg/d. Patients were judged unsuitable for warfarin therapy because they had a specific risk of bleeding (24%), the physician believed that oral anticoagulation with a vitamin K antagonist was inappropriate (50%), or the patient wished to avoid oral anticoagulation therapy (26%). The risk factors for bleeding cited by physicians were an inability to comply with international normalized ratio (INR) monitoring, a predisposition to falling or head trauma, a persistent blood pressure>160/100 mmHg, previous serious bleeding during treatment with a vitamin K antagonist, severe alcohol abuse within 2 years, thrombocytopenia, peptic ulcer disease between 6 months and 1 year before enrollment, and the need for chronic nonsteroidal anti-inflammatory drug (NSAID) therapy. The primary end point was a composite of major vascular events, including stroke, myocardial infarction (MI), non-central nervous system (CNS) systemic embolus, or vascular death. After a median follow-up of 3.6 years, the primary outcome was observed in 11% fewer patients randomized to clopidogrel plus aspirin compared with those randomized to aspirin alone (6.8%/y vs 7.6%/y; P=.01). The significant reduction in the risk of the primary end point “was driven by a substantial reduction in stroke,” said Dr Connolly, professor and director of cardiology, McMaster University, Hamilton, Ontario, Canada. The incidence of stroke was 3.3% per year in the group assigned to aspirin and 2.4% per year in the patients assigned to clopidogrel plus aspirin, corresponding to a 28% relative risk reduction (P<.001). The addition of clopidogrel to aspirin reduced the incidence of disabling and nondisabling strokes by an equal extent, he said. The incidence of MI was reduced by a nonsignificant 22% (P=.08) by adding clopidogrel to aspirin. The risk of major bleeding was increased by 57% in clopidogrel recipients, from 1.3% per year with aspirin alone to 2.0% per year with clopidogrel plus aspirin (P<.001). The incidence of fatal bleeding was 0.2% per year among patients treated with aspirin alone and 0.3% per year among patients assigned to clopidogrel plus aspirin (P=.07). Putting the findings in perspective, Dr Connolly said that treating 1,000 patients with AF for 3 years with clopidogrel plus aspirin rather than aspirin alone would prevent 28 strokes (17 fatal or disabling) and 6 MIs at a cost of 20 (nonstroke) major bleeds, 3 of which would be fatal. He emphasized that warfarin remains the gold standard for preventing stroke in patients with AF, as warfarin has been demonstrated to be significantly superior to both aspirin and the combination of aspirin and clopidogrel in randomized, controlled clinical trials. The results of this trial are available online ahead of print in the New England Journal of Medicine at http://content.nejm.org/cgi/content/full/NEJMoa0901301. |   Practice Tools Coding Counselor Simple and accurate ICD-9 code search. Start Here  Formulary Counselor Find health plan drug coverage in your area. Start Here  Patient Education Print customized patient education handouts. Start Here  Surgical Video Center On-demand surgery demos and presentations. Start Here    
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