Anticoagulants vs. Aspirin After Cerebral Ischemia
Source: Stroke Prevention in Reversible Ischemic Trial (SPIRIT) Study Group. A randomized trial of anticoagulants versus aspirin after cerebral ischemia of presumed arterial origin. Ann Neurol 1997;42:857-865.
A total of 1316 patients who had suffered recent transient ischemic attack or minor ischemic stroke were randomized by a concealed overall program and managed by open assigned drug to assess outcome. Therapy, after appropriate selection of patients not apparently at risk for either agent, consisted of warfarin sufficient to maintain international normalized prothrombin ratios of 3.0-4.5 vs. 30 mg of daily aspirin. Outcome events were centrally masked and consisted of death from all vascular causes, non-fatal stroke or myocardial infarction, or non-fatal bleeding complication.
The first interim analysis of a mean follow-up at 14 months indicated an excessive risk (hazard ratio, 2.3) in the anticoagulated group of 12.4%, n = 651 vs. aspirin 5.4%, n = 665. The authors conclude that "anticoagulant therapy with an INR range of 3.0-4.5 in patients after cerebral ischemia of presumed arterial origin is not safe." Your editor, given these risks of anticoagulants, wonders 1) why it took so long to review the results, and 2) why studies of this kind, using a potentially brain damaging or lethal drug, shouldn’t start with smaller rather than full therapeutic levels since no preliminary data favor the initiating hypothesis. fp
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