Xia Zhang, Gao Ying, Chen Weiqi, Johnston S Claiborne, Amarenco Pierre, Bath Philip M, Wang Xuan, Yan Hongyi, Wang Tingting, Yang Yingying, Zhang Yanli, Wang Mengxing, Jing Jing, Wang Chunjuan, Wang Yongjun, Wang Yilong, Pan Yuesong
Department of Neurology Beijing Tiantan Hospital, Capital Medical University Beijing China.
China National Clinical Research Center for Neurological Diseases Beijing China.
J Am Heart Assoc. 2025 Aug 5;14(15):e041449. doi: 10.1161/JAHA.125.041449. Epub 2025 Jul 17.
Metabolic syndrome (MetS) attenuates antiplatelet agent effects. This study investigated the efficacy and safety of clopidogrel-aspirin therapy for secondary stroke prevention in patients with MetS.
Data were obtained from the INSPIRES (Intensive Statin and Antiplatelet Therapy for Acute High-Risk Intracranial or Extracranial Atherosclerosis) trial. Patients with mild ischemic stroke or high-risk transient ischemic attack were randomized to treatment with clopidogrel-aspirin or aspirin alone within 72 hours after symptom onset. MetS was defined according to the Adult Treatment Panel-III. The primary efficacy outcome was new stroke, and the primary safety outcome was moderate - to - severe bleeding within 90-day follow-up. Differences between groups were estimated with Cox proportional hazards models, with hazard ratio (HR) and 95% CI presented.
This study included 4715 patients, with a mean age of 63.7±9.6 years, 35.8% of women, and 75.8% of patients having MetS. After adjustment for potential confounders, patients with MetS were at higher risk of recurrent stroke (HR, 1.39 [95% CI, 1.06-1.82]; =0.02) but not moderate - to - severe bleeding events (HR, 1.02 [95% CI, 0.47-2.21]; =0.97) as compared with patients without MetS. However, MetS state did not impact the efficacy of clopidogrel-aspirin therapy for recurrent stroke ( for interaction=0.44) and the safety for moderate-to-severe bleeding events ( for interaction=0.54).
MetS was associated with higher risk of recurrent stroke at 90 days. There was no difference in the effect of clopidogrel-aspirin therapy on reducing new stroke and increasing moderate-to-severe bleeding events between patients with and without MetS.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03635749.
代谢综合征（MetS）会减弱抗血小板药物的疗效。本研究调查了氯吡格雷联合阿司匹林治疗对代谢综合征患者二级预防中风的疗效和安全性。
数据来自INSPIRES（急性高危颅内或颅外动脉粥样硬化的强化他汀类药物和抗血小板治疗）试验。轻度缺血性中风或高危短暂性脑缺血发作患者在症状出现后72小时内被随机分为接受氯吡格雷联合阿司匹林治疗或单独使用阿司匹林治疗。代谢综合征根据成人治疗小组III进行定义。主要疗效结局为新发中风，主要安全结局为90天随访期内的中度至重度出血。使用Cox比例风险模型估计组间差异，并给出风险比（HR）和95%置信区间（CI）。
本研究纳入4715例患者，平均年龄63.7±9.6岁，女性占35.8%，代谢综合征患者占75.8%。在对潜在混杂因素进行调整后，与无代谢综合征的患者相比，代谢综合征患者复发性中风的风险更高（HR，1.39[95%CI，1.06 - 1.82]；P = 0.02），但中度至重度出血事件的风险无差异（HR，1.02[95%CI，0.47 - 2.21]；P = 0.97）。然而，代谢综合征状态并未影响氯吡格雷联合阿司匹林治疗复发性中风的疗效（交互作用P = 0.44）以及中度至重度出血事件的安全性（交互作用P = 0.54）。
代谢综合征与90天时复发性中风的较高风险相关。有或无代谢综合征的患者在氯吡格雷联合阿司匹林治疗减少新发中风和增加中度至重度出血事件方面的效果无差异。
