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阿司匹林在缺血性脑卒中后降低主要不良心血管事件方面优于氯吡格雷:一项回顾性全国队列研究。

Aspirin better than clopidogrel on major adverse cardiovascular events reduction after ischemic stroke: A retrospective nationwide cohort study.

机构信息

International Master/PhD Program in Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.

Department of Neurology, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.

出版信息

PLoS One. 2019 Aug 29;14(8):e0221750. doi: 10.1371/journal.pone.0221750. eCollection 2019.

Abstract

BACKGROUND

Several clinical trials reported that clopidogrel was superior to aspirin in secondary stroke prevention by reducing the risk of major adverse cardiovascular events (MACE). We aimed to compare the efficacy of clopidogrel with aspirin in reducing one-year risk of MACE based on real-world evidence from Taiwan Health Insurance Database.

METHODS

We identified ischemic stroke patients between 2000 and 2012 who took aspirin or clopidogrel within 7 days of stroke onset for 1-year follow-up. The primary outcome was one-year MACE including recurrent stroke, acute myocardial infarction, and death. Propensity score matching and conditional Cox proportional hazards regression were conducted to control the confounding factors.

RESULTS

From 9,089 ischemic stroke patients, we found 654 patients on aspirin and 465 patients on clopidogrel who met the selective inclusion criteria. After propensity score matching, 379 patients were selected from each group. The clopidogrel group had a 1.78-fold MACE risk compared with the aspirin group at one-year follow-up (95% CI = 1.41-2.26, p<0.01). The MACE-free rate in the aspirin group was 15.74% higher than in the clopidogrel group at one-year follow-up. Sub-analysis of the three components of MACE showed that clopidogrel conferred higher risk of recurrent stroke (OR 1.43, 95% CI = 1.06-1.92, p 0.02) and acute myocardial infarction (OR 3.72, 95% CI = 1.04-13.3, p 0.04), but no different risk of death than that of aspirin.

CONCLUSIONS

Among first-ever ischemic stroke patients, secondary stroke prevention using clopidogrel was associated with higher rates of MACE than aspirin. Aspirin might have better efficacy in secondary stroke prevention and was associated with lower risk of MACE. The real-world evidence raises the need to re-assess the current therapeutic options in secondary stroke prevention applying aspirin vs. clopidogrel.

摘要

背景

几项临床试验报告称,氯吡格雷通过降低主要不良心血管事件(MACE)的风险,在二级卒中预防方面优于阿司匹林。我们旨在基于来自台湾健康保险数据库的真实世界证据,比较氯吡格雷与阿司匹林在降低一年 MACE 风险方面的疗效。

方法

我们确定了 2000 年至 2012 年期间在卒中发作后 7 天内服用阿司匹林或氯吡格雷的缺血性卒中患者,并进行了为期 1 年的随访。主要结局为一年时的 MACE,包括卒中复发、急性心肌梗死和死亡。采用倾向评分匹配和条件 Cox 比例风险回归来控制混杂因素。

结果

在 9089 例缺血性卒中患者中,我们发现有 654 例患者服用阿司匹林,465 例患者服用氯吡格雷,符合选择性纳入标准。在倾向评分匹配后,从每组中各选择了 379 例患者。氯吡格雷组在 1 年随访时发生 MACE 的风险比阿司匹林组高 1.78 倍(95%CI=1.41-2.26,p<0.01)。阿司匹林组在 1 年随访时的 MACE 无事件率比氯吡格雷组高 15.74%。MACE 三个组成部分的亚分析显示,氯吡格雷增加了卒中复发的风险(OR 1.43,95%CI=1.06-1.92,p 0.02)和急性心肌梗死的风险(OR 3.72,95%CI=1.04-13.3,p 0.04),但与阿司匹林相比,死亡风险没有差异。

结论

在首次发生缺血性卒中的患者中,使用氯吡格雷进行二级卒中预防与阿司匹林相比,MACE 发生率更高。阿司匹林在二级卒中预防方面可能具有更好的疗效,与较低的 MACE 风险相关。真实世界证据表明,需要重新评估目前在二级卒中预防中应用阿司匹林与氯吡格雷的治疗选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e1f4/6715172/8a00dfa55e02/pone.0221750.g001.jpg

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