Journal of the American Heart Association · 2025
Dual Antiplatelet Therapy in Patients With Metabolic Syndrome After Mild Ischemic Stroke or Transient Ischemic Attack.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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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
Аннотация
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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]; P=0.02) but not moderate - to - severe bleeding events (HR, 1.02 [95% CI, 0.47-2.21]; P=0.97) as compared with patients without MetS. However, MetS state did not impact the efficacy of clopidogrel-aspirin therapy for recurrent stroke (P for interaction=0.44) and the safety for moderate-to-severe bleeding events (P for interaction=0.54).
CONCLUSIONS: 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.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03635749.
METHODS: 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.
RESULTS: 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]; P=0.02) but not moderate - to - severe bleeding events (HR, 1.02 [95% CI, 0.47-2.21]; P=0.97) as compared with patients without MetS. However, MetS state did not impact the efficacy of clopidogrel-aspirin therapy for recurrent stroke (P for interaction=0.44) and the safety for moderate-to-severe bleeding events (P for interaction=0.54).
CONCLUSIONS: 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.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03635749.