Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke.
Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke.
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DOI：
10.1056/nejmoa0805002
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发表时间：
2008-09-18
期刊：
影响因子：
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通讯作者：
PRoFESS Study Group
中科院分区：
文献类型：
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作者：
Sacco RL;Diener HC;Yusuf S;Cotton D;Ounpuu S;Lawton WA;Palesch Y;Martin RH;Albers GW;Bath P;Bornstein N;Chan BP;Chen ST;Cunha L;Dahlöf B;De Keyser J;Donnan GA;Estol C;Gorelick P;Gu V;Hermansson K;Hilbrich L;Kaste M;Lu C;Machnig T;Pais P;Roberts R;Skvortsova V;Teal P;Toni D;Vandermaelen C;Voigt T;Weber M;Yoon BW;PRoFESS Study Group
复发性中风是缺血性中风后经常进行的残疾事件。
在这项双盲，2 x-2阶乘试验中，我们随机分配了25毫克阿司匹林加上200 mg延长释放的二吡啶胺，或者每天接受75 mg的氯吡格雷。中风。测试已计划。
在916名患者（9.0％）接受ASA – ERDP的患者中，总共有20,332名患者进行了2.5年。 ]，0.92至1.11）。在ASA – ERDP接受者中，有更多的大量出血事件（419 [4.1％]）比氯吡格雷接受者（365 [3.6％]）（危险比，1.15; 95％CI，1.00至1.32），包括颅内出血（危害比率） ，1.42; 95％CI，1.11至1.83）。 1156个氯吡格雷接受者[11.4％];
该试验不符合非劣势的预定义标准，但与ASA – ERDP和氯吡格雷相似的复发率相似。
Recurrent stroke is a frequent, disabling event after ischemic stroke. This study compared the efficacy and safety of two antiplatelet regimens — aspirin plus extendedrelease dipyridamole (ASA–ERDP) versus clopidogrel. 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. 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). 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.