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氯吡格雷和阿司匹林治疗急性缺血性卒中和高危短暂性脑缺血发作
Clopidogrel and Aspirin in Acute Ischemic Stroke and High-Risk TIA


S. Claiborne Johnston ... 心脑血管疾病 • 2018.07.19
相关阅读
• 氯吡格雷联合阿司匹林治疗对短暂性脑缺血发作或轻度卒中有益 • 缺血性卒中或短暂性脑缺血发作后的二级预防

中国高危非致残性脑血管病二级预防CHANCE研究获欧美力证

 

王伊龙*,杨营营

首都医科大学附属北京天坛医院

*通讯作者

 

轻型缺血性卒中或短暂性脑缺血发作(TIA)在发病90日内复发风险高,达3%~15%。CHANCE研究发现,氯吡格雷联合阿司匹林治疗能有效降低中国人群的卒中复发风险,并且不增加出血事件风险1,然而,此结论是否同样适用于欧美人群尚不明确。2018年5月16日在线发表于NEJM的POINT研究为氯吡格雷联合阿司匹林在该人群的应用增添了新证据2

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摘要


背景

氯吡格雷+阿司匹林联合抗血小板治疗可降低轻型缺血性卒中或短暂性脑缺血发作(TIA)发病后前3个月卒中的复发率。在中国人群中进行的一项联合抗血小板治疗试验显示卒中复发风险降低。我们在一个国际性人群中,对这一联合疗法进行了试验。

 

方法

在一项随机试验中,我们将轻型缺血性卒中或高危TIA患者分组,接受氯吡格雷(第1日600 mg负荷剂量,随后每日75 mg)+阿司匹林(剂量为每日50~325 mg)联合治疗或相同剂量范围的阿司匹林单独治疗。各组的阿司匹林剂量由研究中心的研究者选择。至事件发生时间的分析中,主要疗效结局为90日时复合主要缺血性事件(包括缺血性卒中、心肌梗死或缺血性血管源性死亡)的风险。

 

结果

在269家国际研究中心纳入了总共4,881例患者。由于数据和安全监察委员会确定,在90日时,与阿司匹林单独治疗相比,氯吡格雷+阿司匹林联合治疗与较低的主要缺血性事件风险和较高的大出血风险相关,因此在纳入患者数量达到预计数量的84%之后,停止了试验。氯吡格雷+阿司匹林组2,432例患者中的121例(5.0%)和阿司匹林+安慰剂组2,449例患者中的160例(6.5%)发生了主要缺血性事件(风险比,0.75;95%置信区间[CI],0.59~0.95;P=0.02),大部分事件发生在最初事件发生后的第1周期间。氯吡格雷+阿司匹林组的23例患者(0.9%)和阿司匹林+安慰剂组的10例患者(0.4%)发生了大出血(风险比,2.32;95% CI,1.10~4.87;P=0.02)。

 

结论

在轻型缺血性卒中或高危TIA患者中,与接受阿司匹林单独治疗的患者相比,接受氯吡格雷+阿司匹林联合治疗的患者90日时的主要缺血性事件风险较低,大出血风险较高(由美国国立神经疾病和卒中研究所[National Institute of Neurological Disorders and Stroke]资助;POINT在ClinicalTrials.gov注册号为NCT00991029)。





作者信息

S. Claiborne Johnston, M.D., Ph.D., J. Donald Easton, M.D., Mary Farrant, M.B.A., William Barsan, M.D., Robin A. Conwit, M.D., Jordan J. Elm, Ph.D., Anthony S. Kim, M.D., Anne S. Lindblad, Ph.D., and Yuko Y. Palesch, Ph.D. for the Clinical Research Collaboration, Neurological Emergencies Treatment Trials Network, and the POINT Investigators*
From the Dean’s Office, Dell Medical School, University of Texas at Austin, Austin (S.C.J.); the Department of Neurology, University of California, San Francisco, San Francisco (J.D.E., M.F., A.S.K.); the Department of Emergency Medicine, University of Michigan, Ann Arbor (W.B.); the Division of Clinical Research, National Institute of Neurological Disorders and Stroke, Bethesda (R.A.C.), and Emmes, Rockville (A.S.L.) — both in Maryland; and the Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.J.E., Y.Y.P.). Address reprint requests to Dr. Johnston at Dell Medical School, University of Texas at Austin, 1501 Red River St., Austin, TX 78701, or at clay.johnston@utexas.edu. *A complete list of the POINT Investigators is provided in the Supplementary Appendix, available at NEJM.org.

 

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