Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis
Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis
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DOI：
10.1056/nejmoa043033
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发表时间：
2005-03-31
影响因子：
158.5
通讯作者：
Romano, JG
中科院分区：
文献类型：
--
作者：
Chimowitz, MI;Lynn, MJ;Romano, JG
背景：动脉粥样硬化性颅内动脉狭窄是卒中的一个重要病因。对于这种疾病，华法林通常比阿司匹林更受青睐，但在一项随机试验中尚未对这些治疗方法进行比较。
方法：在一项双盲、多中心临床试验中，我们将经血管造影证实为主要颅内动脉50% - 99%狭窄且伴有短暂性脑缺血发作或卒中的患者随机分配接受华法林（目标国际标准化比值为2.0 - 3.0）或阿司匹林（每天1300毫克）治疗。主要终点是缺血性卒中、脑出血或非卒中性血管原因导致的死亡。
结果：在569名患者被随机分组后，由于担心被分配接受华法林治疗的患者的安全性，停止了招募。在平均1.8年的随访期间，两组的不良事件包括死亡（阿司匹林组为4.3%，华法林组为9.7%；阿司匹林相对于华法林的风险比为0.46；95%置信区间为0.23 - 0.90；P = 0.02）、大出血（分别为3.2%和8.3%；风险比为0.39；95%置信区间为0.18 - 0.84；P = 0.01）以及心肌梗死或猝死（分别为2.9%和7.3%；风险比为0.40；95%置信区间为0.18 - 0.91；P = 0.02）。阿司匹林组血管原因导致的死亡率为3.2%，华法林组为5.9%（P = 0.16）；非血管原因导致的死亡率分别为1.1%和3.8%（P = 0.05）。主要终点在阿司匹林组22.1%的患者和华法林组21.8%的患者中出现（风险比为1.04；95%置信区间为0.73 - 1.48；P = 0.83）。
结论：在本试验中，华法林与不良事件发生率显著升高相关，且相较于阿司匹林没有优势。对于颅内动脉狭窄患者，应优先使用阿司匹林而非华法林。
Background:Atherosclerotic intracranial arterial stenosis is an important cause of stroke. Warfarin is commonly used in preference to aspirin for this disorder, but these therapies have not been compared in a randomized trial.Methods:We randomly assigned patients with transient ischemic attack or stroke caused by angiographically verified 50 to 99 percent stenosis of a major intracranial artery to receive warfarin (target international normalized ratio, 2.0 to 3.0) or aspirin (1300 mg per day) in a double-blind, multicenter clinical trial. The primary end point was ischemic stroke, brain hemorrhage, or death from vascular causes other than stroke.Results:After 569 patients had undergone randomization, enrollment was stopped because of concerns about the safety of the patients who had been assigned to receive warfarin. During a mean follow-up period of 1.8 years, adverse events in the two groups included death (4.3 percent in the aspirin group vs. 9.7 percent in the warfarin group; hazard ratio for aspirin relative to warfarin, 0.46; 95 percent confidence interval, 0.23 to 0.90; P=0.02), major hemorrhage (3.2 percent vs. 8.3 percent, respectively; hazard ratio, 0.39; 95 percent confidence interval, 0.18 to 0.84; P=0.01), and myocardial infarction or sudden death (2.9 percent vs. 7.3 percent, respectively; hazard ratio, 0.40; 95 percent confidence interval, 0.18 to 0.91; P=0.02). The rate of death from vascular causes was 3.2 percent in the aspirin group and 5.9 percent in the warfarin group (P=0.16); the rate of death from nonvascular causes was 1.1 percent and 3.8 percent, respectively (P=0.05). The primary end point occurred in 22.1 percent of the patients in the aspirin group and 21.8 percent of those in the warfarin group (hazard ratio, 1.04; 95 percent confidence interval, 0.73 to 1.48; P=0.83).Conclusions:Warfarin was associated with significantly higher rates of adverse events and provided no benefit over aspirin in this trial. Aspirin should be used in preference to warfarin for patients with intracranial arterial stenosis.