on December 29, 2005
Published online before print December 29, 2005, doi: 10.1161/01.STR.0000198839.61112.ee
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Submitted on August 25, 2005
From the Department of Cardiovascular Medicine (H.S., M.H.) Osaka University Graduate School of Medicine, Suita, Japan; Department of Cardiology (K.I.), Kinki University School of Medicine, Osakasayama, Japan; Department of Cardiovascular Medicine (A.K.), Hokkaido University Graduate School of Medicine, Sapporo, Japan; Division of Cardiology (S.O.), Department of Medicine, Keio University School of Medicine, Tokyo, Japan; First Department of Internal Medicine (Y.M.), Fukushima Medical University, Japan; Division of Cardiovascular and Respiratory Medicine (Y.Y.), Kobe University Graduate School of Medicine, Japan; Cardiovascular Center (T.F.), Matsuyama Red Cross Hospital, Japan; Departments of Medicine and Geriatrics (Y.D.), Kochi Medical School, Nankoku, Japan; Division of Cardiology (S.M.), Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan; Department of Internal Medicine and Cardiology (T.I.), Kitasato University School of Medicine, Sagamihara, Japan; Department of Cardiology (N.T.), Kanazawa Medical University, Japan; Department of Cardiology (K.Y.), Kawasaki Medical School, Kurashiki, Japan; Second Department of Internal Medicine (K.H.), Iwate Medical University, Morioka, Japan; Division of Biostatistics (H.O.), Toyama Medical and Pharmaceutical University, Japan; Department of Neurology (S.U.), Neurological Institute, Tokyo Women’s Medical University, Japan; Department of Clinical Neuroscience and Therapeutics (M.M.), Hiroshima University Graduate School of Medicine, Japan; National Cardiovascular Center (T.Y.), Suita, Japan. * To whom correspondence should be addressed. E-mail: satoz{at}medone.med.osaka-u.ac.jp.
Background and Purpose--Although the efficacy of anticoagulant therapy for primary prevention of stroke in patients with nonvalvular atrial fibrillation (NVAF) has been established, efficacy of antiplatelet therapy for low-risk patients is disputable in Japanese patients because of the frequent hemorrhagic complications. We examined the efficacy and safety of aspirin therapy in Japanese patients with NVAF in a prospective randomized multicenter trial. Methods--Patients with NVAF were randomized to an aspirin group (aspirin at 150 to 200 mg per day) or a control group without antiplatelet or anticoagulant therapy. Primary end points included cardiovascular death, symptomatic brain infarction, or transient ischemic attack. Results--A total of 426 patients were randomized to aspirin group and 445 to no treatment. The trial was stopped earlier because there were 27 primary end point events (3.1% per year; 95% CI, 2.1% to 4.6% per year) in the aspirin group versus 23 (2.4% per year; 95% CI, 1.5% to 3.5% per year) in the control group, suggesting a low possibility of superiority of the aspirin treatment for prevention of the primary end point. In addition, treatment with aspirin caused a marginally increased risk of major bleeding (7 patients; 1.6%) compared with the control group (2 patients; 0.4%; Fisher exact test P=0.101). Conclusions--For prevention of stroke in patients with NVAF, aspirin at 150 to 200 mg per day does not seem to be either effective or safe. Further prospective studies are needed to determine the best preventive therapy for cerebrovascular events in Japanese patients with NVAF.
Revised on November 14, 2005
Accepted on November 16, 2005
Low-Dose Aspirin for Prevention of Stroke in Low-Risk Patients With Atrial Fibrillation/ Japan Atrial Fibrillation Stroke Trial
Hiroshi Sato MD, PhD*;
Key words: aspirin • stroke • thrombosis
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