栓塞的动脉粥样硬化来源是不明来源的栓塞性中风(ESUS)的重要原因。然而,强化双联抗血小板治疗对ESUS疗效的证据有限.我们进行了一项研究,以确定基因导向的双重抗血小板治疗是否可以降低ESUS患者复发性卒中的风险。
■CHANCE-2(氯吡格雷在急性非致残性脑血管事件-II高危患者中的应用)是研究者发起的,多中心,随机化,双盲,安慰剂对照试验,客观比较了中国携带CYP2C19功能丧失等位基因的轻度卒中或短暂性脑缺血发作患者的替格瑞洛加阿司匹林和氯吡格雷加阿司匹林。所有研究参与者被分为ESUS和非ESUS组,用于预设的探索性分析。Cox比例风险模型用于评估ESUS状态与替格瑞洛-阿司匹林和氯吡格雷-阿司匹林双重抗血小板治疗效果的相互作用。调整社会人口统计学和临床因素。
■亚组分析包括CHANCE-2试验中的5796名参与者(占6412名参与者的90.4%),平均年龄为64.9岁(范围,57.0-71.4年),其中1964年(33.9%)为女性。作为研究方案的一部分,这些参与者接受了弥散加权成像。经过系统评价,15.2%的患者(881/5796)被认为患有ESUS。ESUS患者卒中复发的发生率在替格瑞洛-阿司匹林组为5.6%,氯吡格雷-阿司匹林组为9.2%(风险比,0.57[95%CI,0.33-0.99];P=0.04)。在没有ESUS的患者中,各自的发病率分别为5.6%和7.5%(危险比,0.72[95%CI,0.58-0.90];P<0.01)。治疗×ESUS状态交互效应的P值为0.56。
■在这个预设的探索性分析中,在携带CYP2C19功能丧失等位基因并被分类为ESUS的急性缺血性卒中或短暂性脑缺血发作患者中,替格瑞洛联合阿司匹林在90天预防卒中方面优于氯吡格雷联合阿司匹林。
■URL:http://www。临床试验.gov.唯一标识符:NCT04078737。
UNASSIGNED: The atherosclerotic sources of embolism are a significant contributor to embolic stroke of undetermined source (ESUS). However, there is limited evidence for the efficacy of intensive dual antiplatelet therapy for ESUS. We conducted an investigation to determine whether gene-directed dual antiplatelet therapy could reduce the risk of recurrent stroke in patients with ESUS.
UNASSIGNED: CHANCE-2 (Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events-II) was an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled
trial that objectively compared ticagrelor plus aspirin and clopidogrel plus aspirin in patients with minor stroke or transient ischemic attack who carried CYP2C19 loss-of-function alleles in China. All
study participants were classified into ESUS and non-ESUS groups for the prespecified exploratory analysis. Cox proportional hazards models were used to assess the interaction of the state of ESUS with the effects of dual antiplatelet therapy with ticagrelor-aspirin versus clopidogrel-aspirin, adjusting for sociodemographic and clinical factors.
UNASSIGNED: The subgroup analysis comprised 5796 participants (90.4% of the total 6412 participants) in the CHANCE-2
trial, with a median age of 64.9 years (range, 57.0-71.4 years), of whom 1964 (33.9%) were female. These participants underwent diffusion-weighted imaging as part of the
study protocol. After systematic evaluation, 15.2% of patients (881/5796) were deemed to have ESUS. The incidence of stroke recurrence in patients with ESUS was found to be 5.6% in the ticagrelor-aspirin group and 9.2% in the clopidogrel-aspirin group (hazard ratio, 0.57 [95% CI, 0.33-0.99]; P=0.04). In patients without ESUS, the respective incidence rates were 5.6% and 7.5% (hazard ratio, 0.72 [95% CI, 0.58-0.90]; P<0.01). The P value was 0.56 for the treatment × ESUS status interaction effect.
UNASSIGNED: In this prespecified exploratory analysis, ticagrelor with aspirin was superior to clopidogrel with aspirin for preventing stroke at 90 days in patients with acute ischemic stroke or transient ischemic attack who carried CYP2C19 loss-of-function alleles and were classified as ESUS.
UNASSIGNED: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04078737.