Four randomized, controlled clinical trials have been reported comparing warfarin or aspirin to placebo for the primary prevention of stroke or systemic embolism in patients with atrial fibrillation. Two trials studied aspirin. Control patients in the warfarin eligible studies had stroke event rates of 4.5% per year (3.0–7.0) compared to 1.7% per year (0.2–3.4) in the patients treated with warfarin. One of the two studies examining aspirin found a significant reduction in stroke whereas the other did not. Annual rates of major bleeding in the patients treated with warfarin were less than 2%. These studies conclude that all patients with atrial fibrillation should be treated with antithrombotic therapy to prevent cerebral infarction. Warfarin reduces the risk of stroke by about two thirds with an acceptable risk of bleeding.

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