A comparison of warfarin and aspirin for the prevention of recurrent ischemic stroke
A comparison of warfarin and aspirin for the prevention of recurrent ischemic stroke
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DOI：
10.1056/nejmoa011258
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发表时间：
2001-11-15
影响因子：
158.5
通讯作者：
Pullicino, P
中科院分区：
文献类型：
--
作者：
Mohr, JP;Thompson, JLP;Pullicino, P
背景：尽管在缺血性中风患者中使用抗血小板药物（通常是阿司匹林），但复发率仍然很高。因此，我们研究了华法林在预防心源性栓塞方面比阿司匹林有效且优于阿司匹林，在预防既往非心源性缺血性中风患者的复发性缺血性中风方面是否也具有优越性。方法：在一项多中心、双盲、随机试验中，我们比较了华法林的效果（调整剂量以产生 1.4 至 1.4 的国际标准化比率）。 2.8）和阿司匹林（每天 325 毫克）对两年内复发性缺血性卒中或任何原因死亡的合并主要终点的影响。结果：两个随机研究组的基线危险因素相似。在意向治疗分析中，治疗组之间的任何测量结果均未发现显着差异。接受华法林治疗的 1103 名患者中有 196 名达到了死亡或复发性缺血性卒中的主要终点（17.8%），接受阿司匹林治疗的 1103 名患者中有 176 名达到了死亡或复发性缺血性卒中的主要终点（16.0%；P=0.25；华法林与阿司匹林的风险比为 1.13；95% 置信区间为 0.92 至 1.38）。大出血发生率较低（华法林组每 100 患者年 2.22 例，阿司匹林组每 100 患者年 1.49 例）。此外，根据初始卒中原因，主要终点或大出血的频率或时间不存在与治疗相关的显着差异。结论：在两年的时间里，我们发现阿司匹林和华法林在预防复发性缺血性卒中或死亡或大出血发生率方面没有差异。因此，我们认为华法林和阿司匹林都是合理的治疗替代品。
Background: Despite the use of antiplatelet agents, usually aspirin, in patients who have had an ischemic stroke, there is still a substantial rate of recurrence. Therefore, we investigated whether warfarin, which is effective and superior to aspirin in the prevention of cardiogenic embolism, would also prove superior in the prevention of recurrent ischemic stroke in patients with a prior noncardioembolic ischemic stroke.Methods: In a multicenter, double-blind, randomized trial, we compared the effect of warfarin (at a dose adjusted to produce an international normalized ratio of 1.4 to 2.8) and that of aspirin (325 mg per day) on the combined primary end point of recurrent ischemic stroke or death from any cause within two years.Results: The two randomized study groups were similar with respect to base-line risk factors. In the intention-to-treat analysis, no significant differences were found between the treatment groups in any of the outcomes measured. The primary end point of death or recurrent ischemic stroke was reached by 196 of 1103 patients assigned to warfarin (17.8 percent) and 176 of 1103 assigned to aspirin (16.0 percent; P=0.25; hazard ratio comparing warfarin with aspirin, 1.13; 95 percent confidence interval, 0.92 to 1.38). The rates of major hemorrhage were low (2.22 per 100 patient-years in the warfarin group and 1.49 per 100 patient-years in the aspirin group). Also, there were no significant treatment-related differences in the frequency of or time to the primary end point or major hemorrhage according to the cause of the initial stroke.Conclusions: Over a two-year period, we found no difference between aspirin and warfarin in the prevention of recurrent ischemic stroke or death or in the rate of major hemorrhage. Consequently, we regard both warfarin and aspirin as reasonable therapeutic alternatives.