Liu Liping, Wong Ka Sing Lawrence, Leng Xinyi, Pu Yuehua, Wang Yilong, Jing Jing, Zou Xinying, Pan Yuesong, Wang Anxin, Meng Xia, Wang Chunxue, Zhao Xingquan, Soo Yannie, Johnston S Claiborne, Wang Yongjun
Neurology. 2015 Sep 29;85(13):1154-62. doi: 10.1212/WNL.0000000000001972.
AB OBJECTIVE: We aimed to investigate whether the efficacy and safety of clopidogrel plus aspirin vs aspirin alone were consistent between patients with and without intracranial arterial stenosis (ICAS), in the Clopidogrel in High-Risk Patients with Acute Non-disabling Cerebrovascular Events (CHANCE) trial.
We assessed the interaction of the treatment effects of the 2 antiplatelet therapies among patients with and without ICAS, identified by magnetic resonance angiography (MRA) in CHANCE (ClinicalTrials.gov identifier NCT00979589).
Overall, 1,089 patients with MRA images available in CHANCE were included in this subanalysis, 608 patients (55.8%) with ICAS and 481 (44.2%) without. Patients with ICAS had higher rates of recurrent stroke (12.5% vs 5.4%; p<0.0001) at 90 days than those without. But there was no statistically significant treatment by presence of ICAS interaction on either the primary outcome of any stroke (hazard ratio for clopidogrel plus aspirin vs aspirin alone: 0.79 [0.47-1.32] vs 1.12 [0.56-2.25]; interaction p=0.522) or the safety outcome of any bleeding event (interaction p=0.277).
The results indicated higher rate of recurrent stroke in minor stroke or high-risk TIA patients with ICAS than in those without. However, there was no significant difference in the response to the 2 antiplatelet therapies between patients with and without ICAS in the CHANCE trial. Classification of evidence: This study provides Class II evidence that for patients with acute minor stroke or TIA with and without ICAS identified by MRA, clopidogrel plus aspirin is not significantly different than aspirin alone in preventing recurrent stroke.
AB 目的：在氯吡格雷用于急性非致残性脑血管事件高危患者（CHANCE）试验中，我们旨在研究伴有和不伴有颅内动脉狭窄（ICAS）的患者使用氯吡格雷联合阿司匹林与单用阿司匹林的疗效和安全性是否一致。
我们评估了在CHANCE试验中通过磁共振血管造影（MRA）识别的伴有和不伴有ICAS的患者中两种抗血小板治疗的治疗效果的相互作用（ClinicalTrials.gov标识符NCT00979589）。
总体而言，本亚组分析纳入了CHANCE试验中1089例有MRA图像的患者，其中608例（55.8%）有ICAS，481例（44.2%）无ICAS。有ICAS的患者90天时的复发性卒中发生率（12.5%对5.4%；p<0.0001）高于无ICAS的患者。但在任何卒中的主要结局（氯吡格雷联合阿司匹林与单用阿司匹林的风险比：0.79[0.47 - 1.32]对1.12[0.56 - 2..25]；相互作用p = 0.522）或任何出血事件的安全性结局方面，ICAS的存在与治疗之间没有统计学上显著的相互作用（相互作用p = 0.277）。
结果表明，伴有ICAS的轻度卒中或高危短暂性脑缺血发作（TIA）患者的复发性卒中发生率高于无ICAS的患者。然而，在CHANCE试验中，伴有和不伴有ICAS的患者对两种抗血小板治疗的反应没有显著差异。证据分类：本研究提供II类证据，即对于通过MRA识别的伴有和不伴有ICAS的急性轻度卒中和TIA患者，氯吡格雷联合阿司匹林在预防复发性卒中方面与单用阿司匹林没有显著差异。
