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Preventing Stroke Recurrence: Which Antiplatelet Strategy Is Best?

In a randomized trial, aspirin plus extended-release dipyridamole showed similar efficacy compared with clopidogrel, although clopidogrel showed a very slight safety advantage.

The best regimen of antiplatelet agents for the prevention of recurrent stroke has not been established. The Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) was an industry-sponsored, international study of strategies to reduce the risk for recurrent stroke. In the antiplatelet arm of the trial, 20,332 patients were randomized to receive clopidogrel or a combination of aspirin plus extended-release dipyridamole within 120 days after experiencing an ischemic stroke.

Mean patient age was 66, and about one third were women. A total of 6.7% had prior MI, and about one in six had a history of coronary artery disease. Over a mean of 30 months of follow-up, a first recurrent stroke occurred in 9.0% of the patients in the combination-therapy arm, compared with 8.8% of those in the clopidogrel arm (hazard ratio, 1.01; 95% confidence interval, 0.92–1.11); the upper limit of the CI for this comparison extended beyond the prespecified noninferiority margin of 1.075. The rate of combined stroke, MI, and death was identical in the two groups. MI occurred in 1.7% of the combination-therapy group and 1.9% of the clopidogrel group (HR, 0.90; 95% CI, 0.73–1.10). Major hemorrhagic events were more common in the combination-therapy group than in the clopidogrel group (4.1% vs 3.6%; HR, 1.15; 95% CI, 1.00–1.32).

Comment: In this study, aspirin plus extended-release dipyridamole showed similar efficacy to clopidogrel for the prevention of recurrent stroke, although the results did not quite meet the criteria for noninferiority. There seems to be little difference between the two regimens; the only advantage found in this comparison goes to clopidogrel, which conferred a slightly lower risk for major hemorrhagic stroke than did aspirin plus extended-release dipyridamole.

— Harlan M. Krumholz, MD, SM

Published in Journal Watch Cardiology August 27, 2008

Citation(s):

Sacco RL et al. for the PRoFESS Study Group. Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke. N Engl J Med 2008 Aug 27; [e-pub ahead of print]. (http://dx.doi.org/10.1056/NEJMoa0805002)