Authors
Sacco RL, Diener H, Yusuf S, et al.
Title
Aspirin and Extended-Release Dipyridamole versus Clopidogrel for Recurrent Stroke
References
N Engl J Med 2008;359:1238-1251.
Background
Antiplatelet agents decrease the risk of recurrent stroke after an ischemic stroke, however it is unclear which antiplatelet agent is preferred.
Purpose
To compare the relative efficacy and safety of aspirin plus extended- release dipyridamole with that of clopidogrel in patients with a recent ischemic stroke.
Design
2-by-2 factorial, multicenter, double-blind, active and placebo-controlled study 20,332 patients with recent ischemic stroke
Exclusion Criteria
None.
Follow-Up
2.5 years (mean)
Treatment Regimen
Fixed combination of aspirin 25 mg and dipyridamole ER 200mg bid versus Clopidogrel 75 mg daily. Telmisartan 80 mg daily versus placebo
Results
The primary outcome of recurrent stroke was not statistically significantly different between the two groups. In terms of non-inferiority, no conclusions could be made, since the upper limit of the confidence interval extended beyond the prespecified noninferiority margin of 1.075.
Summary
Clopidogrel and the combination of aspirin and extended release dipyridamole (eg. Aggrenox) were similar in decreasing the rate of recurrent stroke and the composite of stroke, MI or vascular death. The predefined criteria of non-inferiority was not met, therefore it could not be determined if either treatment is superior to the other for the prevention of recurrent stroke. Major hemorrhagic events, including intracranial bleed was more frequent in the aspirin/dipyridamole group, however the net risk of recurrent stroke or major hemorrhagic events was similar in both groups.
Implications
None.
Related Figures
[7]