par Sacco, Ralph L.;Diener, Hans-Christoph;Yusuf, Salim;Cotton, Daniel;Ounpuu, Stephanie;Lawton, William A;Palesch, Yuko;Martin, Ricardo;Albers, Gregory W;Bath, Philip;Bornstein, Natan;Chan, Bernard PL;Chen, Sien-Tsong;Cunha, Luis;Dahlöf, Björn;De Keyser, Jacques;Donnan, Geoffrey A;Estol, Conrado;Gorelick, Philip;Gu, Vivian;Hermansson, Karin;Hilbrich, Lutz;Kaste, Markku;Lu, Chuanzhen;Machnig, Thomas;Pais, Prem;Roberts, Robin;Skvortsova, Veronika;Teal, Philip;Toni, Danilo;VanderMaelen, Cam;Voigt, Thor;Weber, Michaël;Yoon, Byung-Woo;PRoFESS Study Group, Massimo;Pandolfo,
Référence The New England journal of medicine, 359, 12, page (1238-1251)
Publication Publié, 2008-09
Référence The New England journal of medicine, 359, 12, page (1238-1251)
Publication Publié, 2008-09
Article révisé par les pairs
Résumé : | BACKGROUND: Recurrent stroke is a frequent, disabling event after ischemic stroke. This study compared the efficacy and safety of two antiplatelet regimens--aspirin plus extended-release dipyridamole (ASA-ERDP) versus clopidogrel. METHODS: In this double-blind, 2-by-2 factorial trial, we randomly assigned patients to receive 25 mg of aspirin plus 200 mg of extended-release dipyridamole twice daily or to receive 75 mg of clopidogrel daily. The primary outcome was first recurrence of stroke. The secondary outcome was a composite of stroke, myocardial infarction, or death from vascular causes. Sequential statistical testing of noninferiority (margin of 1.075), followed by superiority testing, was planned. RESULTS: A total of 20,332 patients were followed for a mean of 2.5 years. Recurrent stroke occurred in 916 patients (9.0%) receiving ASA-ERDP and in 898 patients (8.8%) receiving clopidogrel (hazard ratio, 1.01; 95% confidence interval [CI], 0.92 to 1.11). The secondary outcome occurred in 1333 patients (13.1%) in each group (hazard ratio for ASA-ERDP, 0.99; 95% CI, 0.92 to 1.07). There were more major hemorrhagic events among ASA-ERDP recipients (419 [4.1%]) than among clopidogrel recipients (365 [3.6%]) (hazard ratio, 1.15; 95% CI, 1.00 to 1.32), including intracranial hemorrhage (hazard ratio, 1.42; 95% CI, 1.11 to 1.83). The net risk of recurrent stroke or major hemorrhagic event was similar in the two groups (1194 ASA-ERDP recipients [11.7%], vs. 1156 clopidogrel recipients [11.4%]; hazard ratio, 1.03; 95% CI, 0.95 to 1.11). CONCLUSIONS: The trial did not meet the predefined criteria for noninferiority but showed similar rates of recurrent stroke with ASA-ERDP and with clopidogrel. There is no evidence that either of the two treatments was superior to the other in the prevention of recurrent stroke. (ClinicalTrials.gov number, NCT00153062.) |