Trial of Endovascular Therapy for Acute Ischemic Stroke with Large Infarct

作者全名："Huo, Xiaochuan; Ma, Gaoting; Tong, Xu; Zhang, Xuelei; Pan, Yuesong; Nguyen, Thanh N. N.; Yuan, Guangxiong; Han, Hongxing; Chen, Wenhuo; Wei, Ming; Zhang, Jiangang; Zhou, Zhiming; Yao, Xiaoxi; Wang, Guoqing; Song, Weigen; Cai, Xueli; Nan, Guangxian; Li, Di; Wang, A. Yi-Chou; Ling, Wentong; Cai, Chuwei; Wen, Changming; Wang, En; Zhang, Liyong; Jiang, Changchun; Liu, Yajie; Liao, Geng; Chen, Xiaohui; Li, Tianxiao; Liu, Shudong; Li, Jinglun; Gao, Feng; Ma, Ning; Mo, Dapeng; Song, Ligang; Sun, Xuan; Li, Xiaoqing; Deng, Yiming; Luo, Gang; Lv, Ming; He, Hongwei; Liu, Aihua; Zhang, Jingbo; Mu, Shiqing; Liu, Lian; Jing, Jing; Nie, Ximing; Ding, Zeyu; Du, Wanliang; Zhao, Xingquan; Yang, Pengfei; Liu, Liping; Wang, Yilong; Liebeskind, David S. S.; Pereira, Vitor M.; Ren, Zeguang; Wang, Yongjun; Miao, Zhongrong; ANGEL-ASPECT Investigators"

作者地址："[Huo, Xiaochuan; Ma, Gaoting; Tong, Xu; Zhang, Xuelei; Pan, Yuesong; Gao, Feng; Ma, Ning; Mo, Dapeng; Song, Ligang; Sun, Xuan; Li, Xiaoqing; Deng, Yiming; Luo, Gang; Miao, Zhongrong] Capital Med Univ, Dept Neurol, Intervent Neuroradiol, Beijing, Peoples R China; [Lv, Ming; He, Hongwei; Liu, Aihua; Zhang, Jingbo; Mu, Shiqing; Liu, Lian] Capital Med Univ, Dept Neurosurg, Beijing, Peoples R China; [Jing, Jing; Nie, Ximing; Ding, Zeyu; Du, Wanliang; Zhao, Xingquan; Liu, Liping; Wang, Yilong] Capital Med Univ, Dept Neurol, Beijing, Peoples R China; [Zhang, Xuelei] Beijing Tiantan Hosp, Beijing Inst Brain Disorders, Beijing, Peoples R China; [Huo, Xiaochuan; Ma, Gaoting; Tong, Xu; Zhang, Xuelei; Pan, Yuesong; Gao, Feng; Ma, Ning; Mo, Dapeng; Song, Ligang; Sun, Xuan; Li, Xiaoqing; Deng, Yiming; Luo, Gang; Jing, Jing; Nie, Ximing; Ding, Zeyu; Du, Wanliang; Zhao, Xingquan; Liu, Liping; Wang, Yilong; Wang, Yongjun; Miao, Zhongrong] Capital Med Univ, China Natl Clin Res Ctr Neurol Dis, Beijing, Peoples R China; [Yuan, Guangxiong] Xiangtan Cent Hosp, Dept Emergency, Xiangtan, Peoples R China; [Yao, Xiaoxi] First Peoples Hosp Chenzhou, Dept Neurol, Chenzhou, Peoples R China; [Han, Hongxing] Linyi Peoples Hosp, Dept Neurol, Linyi, Peoples R China; [Wang, Guoqing] Binzhou Peoples Hosp, Dept Neurol, Binzhou, Peoples R China; [Zhang, Liyong] Liaocheng Peoples Hosp, Dept Neurosurg, Liaocheng, Peoples R China; [Chen, Wenhuo] Fujian Med Univ, Zhangzhou Affiliated Hosp, Dept Neurol, Zhangzhou, Peoples R China; [Wei, Ming] Tianjin Huanhu Hosp, Dept Neurosurg, Tianjin, Peoples R China; [Zhang, Jiangang] Anyang Peoples Hosp, Dept Neurol, Anyang, Peoples R China; [Wen, Changming] Nanyang Cent Hosp, Dept Neurol, Nanyang, Peoples R China; [Li, Tianxiao] Zhengzhou Univ, Henan Prov Peoples Hosp, Dept Cerebrovascular Dis, Zhengzhou, Peoples R China; [Zhou, Zhiming] Yijishan Hosp, Wannan Med Coll, Dept Neurol, Wuhu, Peoples R China; [Song, Weigen] Yancheng Third Peoples Hosp, Dept Neurol, Yancheng, Peoples R China; [Cai, Xueli] Lishui Municipal Cent Hosp, Dept Neurol, Lishui, Peoples R China; [Ling, Wentong] Taizhou Hosp Zhejiang Prov, Dept Neurol, Taizhou, Peoples R China; [Chen, Xiaohui] Guangzhou Med Univ, Second Affiliated Hosp, Dept Neurol, Guangzhou, Peoples R China; [Cai, Chuwei] Shantou Cent Hosp, Dept Neurol, Shantou, Peoples R China; [Liu, Yajie] Southern Med Univ, Shenzhen Hosp, Dept Neurol, Shenzhen, Peoples R China; [Liao, Geng] Maoming Peoples Hosp, Dept Neurol, Maoming, Peoples R China; [Jiang, Changchun] Baotou Cent Hosp, Dept Neurol, Baotou, Peoples R China; [Liu, Shudong] Chongqing Med Univ, Yongchuan Hosp, Dept Neurol, Chongqing, Peoples R China; [Li, Jinglun] Southwest Med Univ, Affiliated Hosp, Dept Neurol, Chengdu, Peoples R China; [Yang, Pengfei] Naval Med Univ, Changhai Hosp, Neurovasc Ctr, Shanghai, Peoples R China; [Ren, Zeguang] Guizhou Med Univ, Affiliated Hosp, Dept Neurosurg, Guiyang, Peoples R China; [Nguyen, Thanh N. N.] Boston Med Ctr, Dept Neurol & Radiol, Boston, MA USA; [Liebeskind, David S. S.] Univ Calif Los Angeles, Dept Neurol, Los Angeles, CA USA; [Pereira, Vitor M.] Univ Toronto, St Michaels Hosp, Dept Neurosurg, Div Surg, Toronto, ON, Canada; [Ren, Zeguang] Guizhou Med Univ, Affiliated Hosp, Dept Neurosurg, 28,Guiyi St, Guiyang 550004, Guizhou, Peoples R China; [Wang, Yongjun] Capital Med Univ, Beijing Tian tan Hosp, Dept Neurol, 119,South 4th Ring West Rd, Beijing 100070, Peoples R China; [Miao, Zhongrong] Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Intervent Neuroradiol, 119,South 4th Ring West Rd, Beijing 100070, Peoples R China"

通信作者："Ren, ZG (通讯作者)，Guizhou Med Univ, Affiliated Hosp, Dept Neurosurg, 28,Guiyi St, Guiyang 550004, Guizhou, Peoples R China.; Wang, YJ (通讯作者)，Capital Med Univ, Beijing Tian tan Hosp, Dept Neurol, 119,South 4th Ring West Rd, Beijing 100070, Peoples R China.; Miao, ZR (通讯作者)，Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Intervent Neuroradiol, 119,South 4th Ring West Rd, Beijing 100070, Peoples R China."

来源：NEW ENGLAND JOURNAL OF MEDICINE

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000972518100001

JCR分区：Q1

影响因子：96.2

年份：2023

卷号：　

期号：　

开始页：　

结束页：　

文献类型：Article; Early Access

关键词：　

摘要："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.)"

基金机构：Covidien Healthcare International Trading (Shanghai); Johnson & Johnson MedTech; Genesis MedTech (Shanghai); Shanghai HeartCare Medical Technology

基金资助正文："Supported by unrestricted grants from Covidien Healthcare International Trading (Shanghai), Johnson & Johnson MedTech, Genesis MedTech (Shanghai), and Shanghai HeartCare Medical Technology."