Japanese Postmarket Surveillance of Percutaneous Transluminal Angioplasty and Wingspan Stenting for Intracranial Atherosclerotic Disease

医学 翼展 冲程(发动机) 狭窄 改良兰金量表 血管成形术 经皮 支架 再狭窄 内科学 外科 缺血性中风 缺血 机械工程 工程类 空气动力学 航空航天工程
作者
Hirotoshi Imamura,Nobuyuki Sakai,Chiaki Sakai,Yasuhiro Hasegawa,Akio Hyodo,Koji Iihara,Kazuo Minematsu,Kuniaki Ogasawara
出处
期刊:World Neurosurgery [Elsevier BV]
卷期号:173: e48-e54 被引量:7
标识
DOI:10.1016/j.wneu.2023.01.093
摘要

The Wingspan stent system was approved as a rescue device for angioplasty of intracranial atherosclerotic disease (ICAD) in 2012. We conducted the government-recommended Japanese Postmarket Surveillance of Percutaneous Transluminal Angioplasty and Wingspan Stenting for Intracranial Atherosclerotic Disease to monitor Wingspan safety and performance.In this open-label, single-arm study at 76 centers in Japan, ICAD subjects were treated with the Wingspan stent between 2014 and 2016. Efficacy end points were successful stent deployment and technical success, defined as stenosis improvement to <50%. Safety end points were ischemic stroke, modified Rankin Scale and National Institutes of Health Stroke Scale scores, adverse events, and mortality. Subjects were considered treated outside of current recommendations if not already receiving antithrombotics or if percutaneous transluminal angioplasty and stenting occurred within 7 days of onset.The safety cohort included 305 subjects (mean age: 68.7 + 9.6; 83.3% male). Four subjects were removed due to being out of contract. Therefore, 301 subjects were included (mean age: 68.7 ± 9.7; 84.1% male). Successful stent placement was 96.7%. Technical success was observed in 86.8% of lesions. At 1 year, the rate of restenosis was 15.7%, ischemic stroke was 3.9%, and any stroke was 7.9%. Functionally independent outcome (modified Rankin Scale: 0-2) was 88.9% and mortality 3.0%. Significantly more serious adverse events occurred in subjects treated outside of current recommendations (17.9%) versus subjects treated per current recommendations (8.8%) (P = 0.045).Endovascular treatment using the Wingspan stent for ICAD is safe and effective in the Japanese population.
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