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根据复发性中风风险比较阿司匹林和氯吡格雷双重抗血小板治疗与阿司匹林单药治疗在轻度至中度急性缺血性中风中的有效性:对来自全国多中心登记处的15000名患者的分析

Comparative Effectiveness of Dual Antiplatelet Therapy With Aspirin and Clopidogrel Versus Aspirin Monotherapy in Mild-to-Moderate Acute Ischemic Stroke According to the Risk of Recurrent Stroke: An Analysis of 15 000 Patients From a Nationwide, Multicenter Registry.

作者信息

Lee Hak-Loh, Kim Joon-Tae, Lee Ji Sung, Park Man-Seok, Choi Kang-Ho, Cho Ki-Hyun, Kim Beom Joon, Park Jong-Moo, Kang Kyusik, Lee Soo Joo, Kim Jae Guk, Cha Jae-Kwan, Kim Dae-Hyun, Park Tai Hwan, Park Sang-Soon, Lee Kyung Bok, Lee Jun, Hong Keun-Sik, Cho Yong-Jin, Park Hong-Kyun, Lee Byung-Chul, Yu Kyung-Ho, Sun Oh Mi, Kim Dong-Eog, Ryu Wi-Sun, Choi Jay Chol, Kwon Jee-Hyun, Kim Wook-Joo, Shin Dong-Ick, Sohn Sung Il, Hong Jeong-Ho, Lee Juneyoung, Bae Hee-Joon

机构信息

Department of Neurology, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Korea (H.-L.L., J.-T.K., M.-S.P., K.-H. Choi, K.-H. Cho).

Clinical Research Center, Asan Institute for Life Sciences, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (J.S.L.).

出版信息

Circ Cardiovasc Qual Outcomes. 2020 Nov;13(11):e006474. doi: 10.1161/CIRCOUTCOMES.119.006474. Epub 2020 Nov 17.

Abstract

BACKGROUND

This study compared the effectiveness of dual antiplatelet therapy (DAPT) with clopidogrel-aspirin with that of aspirin monotherapy (AM) in mild-to-moderate acute ischemic stroke considering the risk of recurrent stroke using the Stroke Prognosis Instrument II (SPI-II) score.

METHODS

This study is a retrospective analysis of data from a prospective, nationwide, multicenter stroke registry database between January 2011 and July 2018. We included patients with mild-to-moderate (National Institutes of Health Stroke Scale score ≤10), acute (within 24 hours of onset), noncardioembolic ischemic stroke. The primary outcome was a 3-month composite of stroke (either hemorrhagic or ischemic), myocardial infarction, and all-cause mortality. Propensity scores using the inverse probability of treatment weighting method were used to mitigate baseline imbalances between the DAPT and AM groups and within each subgroup considering SPI-II scores.

RESULTS

Among the 15 430 patients (age, 66±13 years; men, 62.0%), 45.1% (n=6960) received DAPT and 54.9% (n=8470) received AM. Primary outcome events were significantly more frequent in the AM group (16.7%) than in the DAPT group (15.5%; =0.03). Weighted Cox proportional hazards models showed a reduced risk of 3-month primary vascular events in the DAPT group versus the AM group (hazard ratio, 0.84 [0.78-0.92]; <0.001), with no interaction between acute treatment type and SPI-II risk subgroups (=0.44). However, among the high-risk patients with SPI-II scores >7, a substantially larger absolute benefit was observed for 3-month composite vascular events in the DAPT group (weighted absolute risk differences, 5.4%), whereas smaller absolute benefits were observed among patients in the low- or medium-risk SPI-II subgroups (1.7% and 2.4%, respectively).

CONCLUSIONS

Treatment with clopidogrel-aspirin was associated with a reduction in 3-month vascular events compared with AM in mild-to-moderate acute noncardioembolic ischemic stroke patients. Larger magnitudes of the effects of DAPT with clopidogrel-aspirin were observed in the high-risk subgroup by SPI-II risk scores.

摘要

背景

本研究使用卒中预后工具II(SPI-II)评分,比较了氯吡格雷联合阿司匹林双重抗血小板治疗(DAPT)与阿司匹林单药治疗(AM)在轻度至中度急性缺血性卒中患者中预防复发性卒中的有效性。

方法

本研究是一项对2011年1月至2018年7月期间前瞻性、全国性、多中心卒中登记数据库数据的回顾性分析。纳入轻度至中度(美国国立卫生研究院卒中量表评分≤10分)、急性(发病24小时内)、非心源性栓塞性缺血性卒中患者。主要结局为3个月时卒中(出血性或缺血性)、心肌梗死和全因死亡率的复合结局。采用治疗权重逆概率法的倾向评分来减轻DAPT组和AM组之间以及各亚组内基于SPI-II评分的基线不平衡。

结果

在15430例患者(年龄66±13岁;男性占62.0%)中,45.1%(n = 6960)接受DAPT,54.9%(n = 8470)接受AM。AM组的主要结局事件发生率(16.7%)显著高于DAPT组(15.5%;P = 0.03)。加权Cox比例风险模型显示,与AM组相比,DAPT组3个月时主要血管事件风险降低(风险比,0.84[0.78 - 0.92];P < 0.001),急性治疗类型与SPI-II风险亚组之间无交互作用(P = 0.44)。然而,在SPI-II评分>7的高危患者中,DAPT组3个月时复合血管事件的绝对获益明显更大(加权绝对风险差异为5.4%),而在SPI-II低风险或中风险亚组患者中观察到的绝对获益较小(分别为1.7%和2.4%)。

结论

在轻度至中度急性非心源性栓塞性缺血性卒中患者中,与AM相比,氯吡格雷联合阿司匹林治疗可降低3个月时的血管事件发生率。根据SPI-II风险评分,在高危亚组中观察到氯吡格雷联合阿司匹林DAPT的效果更显著。

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