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(Stroke. 2006;37:447.)
© 2006 American Heart Association, Inc.

Original Contributions

Low-Dose Aspirin for Prevention of Stroke in Low-Risk Patients With Atrial Fibrillation

Japan Atrial Fibrillation Stroke Trial

Hiroshi Sato, MD, PhD; Kinji Ishikawa, MD, PhD; Akira Kitabatake, MD, PhD; Satoshi Ogawa, MD, PhD; Yukio Maruyama, MD, PhD; Yoshiyuki Yokota, MD, PhD; Takaya Fukuyama, MD, PhD; Yoshinori Doi, MD, PhD; Seibu Mochizuki, MD, PhD; Tohru Izumi, MD, PhD; Noboru Takekoshi, MD, PhD; Kiyoshi Yoshida, MD, PhD; Katsuhiko Hiramori, MD, PhD; Hideki Origasa, PhD; Shinichiro Uchiyama, MD, PhD; Masayasu Matsumoto, MD, PhD; Takenori Yamaguchi, MD, PhD; Masatsugu Hori, MD, PhD on behalf of the Japan Atrial Fibrillation Stroke Trial (JAST) Group

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.

Reprint requests to Hiroshi Sato, MD, Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka 565-0871, Japan. 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.

Key Words: aspirin • stroke • thrombosis

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