Short- versus long-term Dual AntiPlatelet Therapy for Stent-Assisted treatment of CErebral aneurysm (DAPTS ACE): a multicenter, open-label, randomized clinical trial

医学 阿司匹林 随机对照试验 动脉瘤 冲程(发动机) 支架 内科学 氯吡格雷 脑梗塞 随机化 临床试验 外科 心脏病学 缺血 机械工程 工程类
作者
Tomohiko Ozaki,Hiroshi Yamagami,Masafumi Morimoto,Taketo Hatano,Hidenori Oishi,Koichi Haraguchi,Shinichi Yoshimura,Kenji Sugiu,Koji Iihara,Yuji Matsumaru,Yasushi Matsumoto,Tetsu Satow,Mikito Hayakawa,Chiaki Sakai,Susumu Miyamoto,Kazuo Kitagawa,Takashi Daimon,Tatsuo Kagimura,Nobuyuki Sakai
出处
期刊:Journal of NeuroInterventional Surgery [BMJ]
卷期号:16 (2): 171-176 被引量:3
标识
DOI:10.1136/jnis-2022-019867
摘要

Background The optimal duration of dual antiplatelet therapy (DAPT) after stent-assisted coil embolization (SACE) for cerebral aneurysm remains uncertain. This randomized trial of short- versus long-term Dual AntiPlatelet Therapy for Stent-Assisted treatment of CErebral aneurysm (DAPTS ACE) aimed to clarify whether long-term DAPT can reduce the occurrence of ischemic stroke in patients with cerebral aneurysms treated by SACE compared with short-term DAPT. Methods Patients treated for cerebral aneurysm with SACE were enrolled from 17 hospitals in Japan. Patients were enrolled within 30 days after SACE and assigned in a 1:1 ratio to receive long-term (12 months) or short-term (3 months) DAPT with aspirin and clopidogrel. Randomization was performed centrally through a web-based system. The primary outcome was the time to ischemic stroke event during 3 to 12 months after SACE. This trial was registered with the Japan Registry of Clinical Trials (jRCTs051180141). Results A total of 142 patients were recruited from November 4, 2016 to January 7, 2019. Among them, 65 and 68 patients assigned to the long- and short-term DAPT groups, respectively, were included in the full analysis set. Ischemic stroke occurred in no patients in the long-term DAPT group and in one patient in the short-term DAPT group. The incidence rate did not differ between the groups (0.0 vs 2.1/100 person-years; log rank test, P=0.33). Conclusions In this multicenter randomized controlled trial, there was not a statistically significant difference in the rate of ischemic strokes between long- and short-term DAPT.
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