Vascular Neurology, Department of Neurology Beijing Tiantan Hospital, Capital Medical University Beijing China.
China National Clinical Research Center for Neurological Diseases Beijing Tiantan Hospital, Capital Medical University Beijing China.
J Am Heart Assoc. 2023 Nov 7;12(21):e031611. doi: 10.1161/JAHA.123.031611. Epub 2023 Oct 27.
Background This study aimed to investigate the efficacy and safety of ticagrelor-aspirin versus clopidogrel-aspirin in Chinese patients by the presence and clinical presentation of intracranial artery stenosis (ICAS) using randomized trial data from the CHANCE-2 (Clopidogrel in High-Risk Patients With Acute Nondisabling Cerebrovascular Events-II) trial. Methods and Results A total of 6412 patients with minor stroke or transient ischemic attack who carried loss-of-function alleles were randomized to either the ticagrelor-aspirin or clopidogrel-aspirin group. Patients without imaging of the intracranial artery were excluded from the nonprespecified subgroup analysis of CHANCE-2. All patients included were classified into the following groups: without ICAS, symptomatic ICAS, or asymptomatic ICAS. The primary efficacy outcome was new strokes within 90 days. There were 5893 patients (median age, 64.8 years; 33.9% women) included, and 172 (4.9%), 171 (10.5%), and 57 (7.7%) cases of new strokes occurred within 90 days in the without ICAS, with symptomatic ICAS, and with asymptomatic ICAS groups, respectively. Ticagrelor-aspirin was associated with reduced risk of new stroke in patients without ICAS (62 [3.5%] versus 110 [6.3%]; hazard ratio [HR], 0.57 [95% CI, 0.41-0.78]) but not in those with symptomatic ICAS (HR, 0.77 [95% CI, 0.56-1.05]) or in those with asymptomatic ICAS (HR, 0.77 [95% CI, 0.43-1.38]) compared with clopidogrel-aspirin ( for interaction=0.14). There were no significant differences in the proportion of severe or moderate bleeding events among different ICAS groups. Conclusions Patients without ICAS received a significantly greater benefit from ticagrelor-aspirin than clopidogrel-aspirin after minor ischemic stroke or transient ischemic attack, and there was no statistically significant difference between treatments in patients with symptomatic ICAS or asymptomatic ICAS. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04078737.
背景 本研究旨在通过 CHANCE-2（氯吡格雷在伴有急性非致残性脑血管事件的高危患者-2）试验的随机试验数据，研究替格瑞洛-阿司匹林与氯吡格雷-阿司匹林在中国颅内动脉狭窄（ICAS）患者中的疗效和安全性。
方法和结果 共有 6412 名携带功能丧失等位基因的小卒中和短暂性脑缺血发作患者被随机分为替格瑞洛-阿司匹林或氯吡格雷-阿司匹林组。未进行颅内动脉影像学检查的患者被排除在 CHANCE-2 的非预设亚组分析之外。所有纳入的患者分为以下三组：无 ICAS、有症状性 ICAS 和无症状性 ICAS。主要疗效终点为 90 天内新发卒中和。共纳入 5893 例患者（中位年龄 64.8 岁，33.9%为女性），90 天内无 ICAS、有症状性 ICAS 和无症状性 ICAS 组分别有 172（4.9%）、171（10.5%）和 57（7.7%）例新发卒中和。与氯吡格雷-阿司匹林相比，替格瑞洛-阿司匹林降低了无 ICAS 患者新发卒中的风险（62[3.5%]例 vs 110[6.3%]例；危险比[HR]，0.57[95%可信区间，0.41-0.78]），但在有症状性 ICAS（HR，0.77[95%可信区间，0.56-1.05]）或无症状性 ICAS（HR，0.77[95%可信区间，0.43-1.38]）患者中无差异（交互检验 P=0.14）。不同 ICAS 组之间严重或中度出血事件的比例无显著差异。
结论 与氯吡格雷-阿司匹林相比，替格瑞洛-阿司匹林在小卒中和短暂性脑缺血发作后使无 ICAS 患者显著获益，而在有症状性 ICAS 或无症状性 ICAS 患者中，两种治疗方法之间无统计学差异。
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