Background Despite the use of antiplatelet agents, usually aspirin,in patients who have had an ischemic stroke, there is stilla substantial rate of recurrence. Therefore, we investigatedwhether warfarin, which is effective and superior to aspirinin the prevention of cardiogenic embolism, would also provesuperior in the prevention of recurrent ischemic stroke in patientswith a prior noncardioembolic ischemic stroke.
Methods In a multicenter, double-blind, randomized trial, wecompared the effect of warfarin (at a dose adjusted to producean international normalized ratio of 1.4 to 2.8) and that ofaspirin (325 mg per day) on the combined primary end point ofrecurrent ischemic stroke or death from any cause within twoyears.
Results The two randomized study groups were similar with respectto base-line risk factors. In the intention-to-treat analysis,no significant differences were found between the treatmentgroups in any of the outcomes measured. The primary end pointof death or recurrent ischemic stroke was reached by 196 of1103 patients assigned to warfarin (17.8 percent) and 176 of1103 assigned to aspirin (16.0 percent; P=0.25; hazard ratiocomparing warfarin with aspirin, 1.13; 95 percent confidenceinterval, 0.92 to 1.38). The rates of major hemorrhage werelow (2.22 per 100 patient-years in the warfarin group and 1.49per 100 patient-years in the aspirin group). Also, there wereno significant treatment-related differences in the frequencyof or time to the primary end point or major hemorrhage accordingto the cause of the initial stroke.
Conclusions Over a two-year period, we found no difference betweenaspirin and warfarin in the prevention of recurrent ischemicstroke or death or in the rate of major hemorrhage. Consequently,we regard both warfarin and aspirin as reasonable therapeuticalternatives.
Source Information
From the Neurological Institute (J.P.M., R.M.L., R.L.S.) and the Department of Biostatistics (J.L.P.T., B.L.), Columbia Presbyterian Medical Center, New York; Massachusetts General Hospital, Boston (K.L.F., J.P.K.); Stanford University Medical Center, Palo Alto, Calif. (G.W.A.); the University of Kentucky Medical Center, Louisville (L.C.P.); University of Iowa Health Care, Iowa City (H.P.A.); the University of California at San Diego, San Diego (C.M.J.); and the State University of New York at Buffalo, Buffalo (P.P.).
Address reprint requests to Dr. Mohr at the Neurological Institute, 710 W. 168th St., New York, NY 10032, or at jpm10{at}columbia.edu.
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