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(Stroke. 1997;28:1015-1021.)
© 1997 American Heart Association, Inc.
Articles |
Indobufen Versus Warfarin in the Secondary Prevention of Major Vascular Events in Nonrheumatic Atrial Fibrillation
From Istituto Malattie Nervose e Mentali, Università di Roma and IRCCS NeuroMed Pozzilli Isernia (C.M.); Istituto Malattie Nervose e Mentali, Università di Roma (G.A., F.F.); Istituto di Tecnologie Biomediche Avanzate Consiglio Nazionale delle Ricerche, Milano (A.N.); II Clinica Medica Policlinico Umberto I, Roma (S.M., M.T.); Dipartimento Cardiologico De Gasperis, Ospedale Cà Granda-Niguarda, Milano (G.C.); Divisione di Cardiologia, Ospedale di Crema (G.M.); Direzione Medica Pharmacia & Upjohn, Milano (M.L., F.P.); and Cattedra e Divisione di Angiologia, Università di Bologna (S.C.) (Italy); for the SIFA Investigators.
Correspondence to Professor Cristoforo Morocutti, MD, Istituto di Malattie Nervose e Mentali, Università La Sapienza, Viale dell'Università 30, 00185 Roma, Italy.
Background and Purpose The results of a large prospective randomized trial have shown the efficacy of oral anticoagulation in the secondary prevention of major vascular events in patients with nonrheumatic atrial fibrillation (NRAF); less well established is the role of antiplatelet agents. The present study compared the effects of indobufen, a reversible inhibitor of platelet cyclooxygenase, with those of warfarin in this setting.
Methods A total of 916 patients with NRAF and a recent
(
15 days) cerebral ischemic episode were admitted to this
multicenter, randomized study, during which they were treated with
either indobufen (100 or 200 mg BID) or warfarin (to obtain an
international normalized ratio of 2.0 to 3.5) for 12 months. The two
groups (462 on indobufen and 454 on warfarin) were well balanced in
terms of their main baseline characteristics. The primary outcome of
the study was the combined incidence of nonfatal stroke (including
intracerebral bleeding), pulmonary or systemic
embolism, nonfatal myocardial infarction, and vascular death.
Results At the end of follow-up, the incidence of primary outcome events was 10.6% in the indobufen group (95% confidence interval, 7.7% to 13.5%) and 9.0% in the warfarin group (95% confidence interval, 6.3% to 11.8%), with no statistically significant difference between treatments. The frequency of noncerebral major bleeding complications was low: only four cases (0.9%) of gastrointestinal bleeding were observed, all of them in the warfarin group.
Conclusions We conclude that, within the limitations of its design, this study may help the medical community in devising appropriate antithrombotic strategies for NRAF patients for whom oral anticoagulants are contraindicated or do not represent a feasible approach to treatment.
Key Words: antiplatelet therapy • atrial fibrillation • thromboembolism • warfarin
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