Trial of Endovascular Thrombectomy for Large Ischemic Strokes

医学 改良兰金量表 优势比 置信区间 冲程(发动机) 随机对照试验 大脑中动脉 颈内动脉 灌注扫描 闭塞 内科学 灌注 缺血性中风 缺血 机械工程 工程类
作者
Amrou Sarraj,Ameer E Hassan,Michael Abraham,Santiago Ortega‐Gutiérrez,Scott E. Kasner,Muhammad Shazam Hussain,Michael Chen,Spiros Blackburn,Clark Sitton,Leonid Churilov,Sophia Sundararajan,Yin Hu,Nabeel Herial,Pascal Jabbour,Daniel Gibson,Adam N. Wallace,Juan F. Arenillas,Jenny P. Tsai,Ronald F. Budzik,William J. Hicks
出处
期刊:The New England Journal of Medicine [Massachusetts Medical Society]
卷期号:388 (14): 1259-1271 被引量:532
标识
DOI:10.1056/nejmoa2214403
摘要

Trials of the efficacy and safety of endovascular thrombectomy in patients with large ischemic strokes have been carried out in limited populations. Download a PDF of the Research Summary. We performed a prospective, randomized, open-label, adaptive, international trial involving patients with stroke due to occlusion of the internal carotid artery or the first segment of the middle cerebral artery to assess endovascular thrombectomy within 24 hours after onset. Patients had a large ischemic-core volume, defined as an Alberta Stroke Program Early Computed Tomography Score of 3 to 5 (range, 0 to 10, with lower scores indicating larger infarction) or a core volume of at least 50 ml on computed tomography perfusion or diffusion-weighted magnetic resonance imaging. Patients were assigned in a 1:1 ratio to endovascular thrombectomy plus medical care or to medical care alone. The primary outcome was the modified Rankin scale score at 90 days (range, 0 to 6, with higher scores indicating greater disability). Functional independence was a secondary outcome. The trial was stopped early for efficacy; 178 patients had been assigned to the thrombectomy group and 174 to the medical-care group. The generalized odds ratio for a shift in the distribution of modified Rankin scale scores toward better outcomes in favor of thrombectomy was 1.51 (95% confidence interval [CI], 1.20 to 1.89; P<0.001). A total of 20% of the patients in the thrombectomy group and 7% in the medical-care group had functional independence (relative risk, 2.97; 95% CI, 1.60 to 5.51). Mortality was similar in the two groups. In the thrombectomy group, arterial access-site complications occurred in 5 patients, dissection in 10, cerebral-vessel perforation in 7, and transient vasospasm in 11. Symptomatic intracranial hemorrhage occurred in 1 patient in the thrombectomy group and in 2 in the medical-care group. Among patients with large ischemic strokes, endovascular thrombectomy resulted in better functional outcomes than medical care but was associated with vascular complications. Cerebral hemorrhages were infrequent in both groups. (Funded by Stryker Neurovascular; SELECT2 ClinicalTrials.gov number, NCT03876457.) QUICK TAKE VIDEO SUMMARYEndovascular Thrombectomy for Large Ischemic Strokes 02:32
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