Trial of Endovascular Treatment of Acute Basilar-Artery Occlusion

医学 改良兰金量表 溶栓 基底动脉 随机对照试验 冲程(发动机) 置信区间 闭塞 脑出血 外科 内科学 蛛网膜下腔出血 心肌梗塞 缺血性中风 缺血 工程类 机械工程
作者
Chunrong Tao,Raul G Nogueira,Yukui Zhang,Jun Sun,Hongxing Han,Guangxiong Yuan,Changming Wen,Peiyang Zhou,Wenhuo Chen,Guoyong Zeng,Yuwen Li,Zhengfei Ma,Chuanqing Yu,Junfeng Su,Zhiming Zhou,Zhongjun Chen,Geng Liao,Yaxuan Sun,Youquan Ren,Hui Zhang,Jie Chen,Xincan Yue,Guodong Xiao,Li Wang,Rui Liu,Wenhua Liu,Yong Liu,Li Wang,Chao Zhang,Tianlong Liu,Jianlong Song,Rui Li,Pengfei Xu,Yamei Yin,Guoping Wang,Blaise Baxter,Adnan I. Qureshi,Xinfeng Liu,Wei Hu
出处
期刊:The New England Journal of Medicine [New England Journal of Medicine]
卷期号:387 (15): 1361-1372 被引量:309
标识
DOI:10.1056/nejmoa2206317
摘要

Data from trials investigating the effects and risks of endovascular thrombectomy for the treatment of stroke due to basilar-artery occlusion are limited.We conducted a multicenter, prospective, randomized, controlled trial of endovascular thrombectomy for basilar-artery occlusion at 36 centers in China. Patients were assigned, in a 2:1 ratio, within 12 hours after the estimated time of basilar-artery occlusion to receive endovascular thrombectomy or best medical care (control). The primary outcome was good functional status, defined as a score of 0 to 3 on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]), at 90 days. Secondary outcomes included a modified Rankin scale score of 0 to 2, distribution across the modified Rankin scale score categories, and quality of life. Safety outcomes included symptomatic intracranial hemorrhage at 24 to 72 hours, 90-day mortality, and procedural complications.Of the 507 patients who underwent screening, 340 were in the intention-to-treat population, with 226 assigned to the thrombectomy group and 114 to the control group. Intravenous thrombolysis was used in 31% of the patients in the thrombectomy group and in 34% of those in the control group. Good functional status at 90 days occurred in 104 patients (46%) in the thrombectomy group and in 26 (23%) in the control group (adjusted rate ratio, 2.06; 95% confidence interval [CI], 1.46 to 2.91, P<0.001). Symptomatic intracranial hemorrhage occurred in 12 patients (5%) in the thrombectomy group and in none in the control group. Results for the secondary clinical and imaging outcomes were generally in the same direction as those for the primary outcome. Mortality at 90 days was 37% in the thrombectomy group and 55% in the control group (adjusted risk ratio, 0.66; 95% CI, 0.52 to 0.82). Procedural complications occurred in 14% of the patients in the thrombectomy group, including one death due to arterial perforation.In a trial involving Chinese patients with basilar-artery occlusion, approximately one third of whom received intravenous thrombolysis, endovascular thrombectomy within 12 hours after stroke onset led to better functional outcomes at 90 days than best medical care but was associated with procedural complications and intracerebral hemorrhage. (Funded by the Program for Innovative Research Team of the First Affiliated Hospital of USTC and others; ATTENTION ClinicalTrials.gov number, NCT04751708.).
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