• N. Engl. J. Med. · Apr 2023

    Randomized Controlled Trial Multicenter Study

    Trial of Endovascular Therapy for Acute Ischemic Stroke with Large Infarct.

    • Xiaochuan Huo, Gaoting Ma, Xu Tong, Xuelei Zhang, Yuesong Pan, Thanh N Nguyen, Guangxiong Yuan, Hongxing Han, Wenhuo Chen, Ming Wei, Jiangang Zhang, Zhiming Zhou, Xiaoxi Yao, Guoqing Wang, Weigen Song, Xueli Cai, Guangxian Nan, Di Li, A Yi-Chou Wang, Wentong Ling, Chuwei Cai, Changming Wen, En Wang, Liyong Zhang, Changchun Jiang, Yajie Liu, Geng Liao, Xiaohui Chen, Tianxiao Li, Shudong Liu, Jinglun Li, Feng Gao, Ning Ma, Dapeng Mo, Ligang Song, Xuan Sun, Xiaoqing Li, Yiming Deng, Gang Luo, Ming Lv, Hongwei He, Aihua Liu, Jingbo Zhang, Shiqing Mu, Lian Liu, Jing Jing, Ximing Nie, Zeyu Ding, Wanliang Du, Xingquan Zhao, Pengfei Yang, Liping Liu, Yilong Wang, David S Liebeskind, Vitor M Pereira, Zeguang Ren, Yongjun Wang, Zhongrong Miao, and ANGEL-ASPECT Investigators.
    • From Interventional Neuroradiology, Department of Neurology (X.H., G.M., X.T., X. Zhang, Y.P., F.G., N.M., D.M., L.S., X.S., X.L., Y.D., G. Luo, Z.M.), and the Departments of Neurosurgery (M.L., H. He, A.L., Jingbo Zhang, S.M., Lian Liu), and Neurology (J.J., X.N., Z.D., W.D., X. Zhao, Liping Liu, Yilong Wang, Yongjun Wang), Beijing Tiantan Hospital, and Beijing Institute for Brain Disorders (X. Zhang), Capital Medical University, and China National Clinical Research Center for Neurological Diseases (X.H., G.M., X.T., X. Zhang, Y.P., F.G., N.M., D.M., L.S., X.S., X.L., Y.D., G. Luo, J.J., X.N., Z.D., W.D., X. Zhao, Liping Liu, Yilong Wang, Yongjun Wang, Z.M.), Beijing, the Department of Emergency, Xiangtan Central Hospital, Xiangtan (G.Y.), the Department of Neurology, First People's Hospital of Chenzhou, Chenzhou (X.Y.), the Department of Neurology, Linyi People's Hospital, Linyi (H. Han), the Department of Neurology, Binzhou People's Hospital, Binzhou (G.W.), the Department of Neurosurgery, Liaocheng People's Hospital, Liaocheng (L.Z.), the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Tianjin Huanhu Hospital, Tianjin (M.W.), the Department of Neurology, Anyang People's Hospital, Anyang (Jiangang Zhang), the Department of Neurology, Nanyang Central Hospital, Nanyang (C.W.), and the Department of Cerebrovascular Disease, Henan Provincial People's Hospital Zhengzhou University, Zhengzhou (T.L.), the Department of Neurology, Yijishan Hospital of Wannan Medical College, Wuhu (Z.Z.), the Department of Neurology, Yancheng Third People's Hospital, Yancheng (W.S.), the Department of Neurology, Lishui Municipal Central Hospital, Lishui (X. Cai), the Department of Neurology, Taizhou Hospital of Zhejiang Province, Taizhou (E.W.), the Department of Neurology, China-Japan Union Hospital of Jilin University, Changchun (G.N.), the Department of Neurointervention, Dalian Municipal Central Hospital, Dalian Medical University, Dalian (D.L.), the Department of Neurosurgery, Guangdong Provincial Hospital of Chinese Medicine (A.Y.-C.W.), the Department of Neurology, Zhongshan City People's Hospital (W.L.), and the Department of Neurology, Second Affiliated Hospital of Guangzhou Medical University (X. Chen), Guangzhou, the Department of Neurology, Shantou Central Hospital, Shantou (C.C.), the Department of Neurology, Shenzhen Hospital, Southern Medical University, Shenzhen (Y.L.), the Department of Neurology, Maoming People's Hospital, Maoming (G. Liao), the Department of Neurology, Baotou Central Hospital, Baotou (C.J.), the Department of Neurology, Yongchuan Hospital of Chongqing Medical University, Chongqing (S.L.), the Department of Neurology, the Affiliated Hospital of Southwest Medical University, Chengdu (J.L.), the Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai (P.Y.), and the Department of Neurosurgery, the Affiliated Hospital of Guizhou Medical University, Guiyang (Z.R.) - all in China; the Department of Neurology and Radiology, Boston Medical Center, Boston (T.N.N.); the Department of Neurology, University of California, Los Angeles, Los Angeles (D.S.L.); and the Department of Neurosurgery, Division of Surgery, St. Michael's Hospital, University of Toronto, Toronto (V.M.P.).
    • N. Engl. J. Med. 2023 Apr 6; 388 (14): 127212831272-1283.

    BackgroundThe role of endovascular therapy for acute stroke with a large infarction has not been extensively studied in differing populations.MethodsWe conducted a multicenter, prospective, open-label, randomized trial in China involving patients with acute large-vessel occlusion in the anterior circulation and an Alberta Stroke Program Early Computed Tomography Score of 3 to 5 (range, 0 to 10, with lower values indicating larger infarction) or an infarct-core volume of 70 to 100 ml. Patients were randomly assigned in a 1:1 ratio within 24 hours from the time they were last known to be well to undergo endovascular therapy and receive medical management or to receive medical management alone. The primary outcome was the score on the modified Rankin scale at 90 days (scores range from 0 to 6, with higher scores indicating greater disability), and the primary objective was to determine whether a shift in the distribution of the scores on the modified Rankin scale at 90 days had occurred between the two groups. Secondary outcomes included scores of 0 to 2 and 0 to 3 on the modified Rankin scale. The primary safety outcome was symptomatic intracranial hemorrhage within 48 hours after randomization.ResultsA total of 456 patients were enrolled; 231 were assigned to the endovascular-therapy group and 225 to the medical-management group. Approximately 28% of the patients in both groups received intravenous thrombolysis. The trial was stopped early owing to the efficacy of endovascular therapy after the second interim analysis. At 90 days, a shift in the distribution of scores on the modified Rankin scale toward better outcomes was observed in favor of endovascular therapy over medical management alone (generalized odds ratio, 1.37; 95% confidence interval, 1.11 to 1.69; P = 0.004). Symptomatic intracranial hemorrhage occurred in 14 of 230 patients (6.1%) in the endovascular-therapy group and in 6 of 225 patients (2.7%) in the medical-management group; any intracranial hemorrhage occurred in 113 (49.1%) and 39 (17.3%), respectively. Results for the secondary outcomes generally supported those of the primary analysis.ConclusionsIn a trial conducted in China, patients with large cerebral infarctions had better outcomes with endovascular therapy administered within 24 hours than with medical management alone but had more intracranial hemorrhages. (Funded by Covidien Healthcare International Trading [Shanghai] and others; ANGEL-ASPECT ClinicalTrials.gov number, NCT04551664.).Copyright © 2023 Massachusetts Medical Society.

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