大面积梗死急性缺血性卒中血管内治疗试验

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

作者信息

Huo Xiaochuan, Ma Gaoting, Tong Xu, Zhang Xuelei, Pan Yuesong, Nguyen Thanh 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, Pereira Vitor M, Ren Zeguang, Wang Yongjun, Miao Zhongrong

机构信息

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.).

出版信息

N Engl J Med. 2023 Apr 6;388(14):1272-1283. doi: 10.1056/NEJMoa2213379. Epub 2023 Feb 10.

DOI:10.1056/NEJMoa2213379

PMID:36762852

Abstract

BACKGROUND

The role of endovascular therapy for acute stroke with a large infarction has not been extensively studied in differing populations.

METHODS

We 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.

RESULTS

A 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.

CONCLUSIONS

In 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.).

摘要

背景

血管内治疗在不同人群中对大面积梗死急性卒中的作用尚未得到广泛研究。

方法

我们在中国进行了一项多中心、前瞻性、开放标签、随机试验，纳入前循环急性大血管闭塞且阿尔伯塔卒中项目早期计算机断层扫描评分3至5分（范围为0至10分，分数越低表明梗死面积越大）或梗死核心体积70至100毫升的患者。患者从最后一次已知健康状态起24小时内按1:1比例随机分组，分别接受血管内治疗并接受药物治疗管理或仅接受药物治疗管理。主要结局是90天时的改良Rankin量表评分（评分范围为0至6分，分数越高表明残疾程度越高），主要目的是确定两组之间90天时改良Rankin量表评分分布是否发生变化。次要结局包括改良Rankin量表0至2分和0至3分。主要安全结局是随机分组后48小时内出现症状性颅内出血。

结果

共纳入456例患者；231例被分配至血管内治疗组，225例被分配至药物治疗管理组。两组中约28%的患者接受了静脉溶栓治疗。在第二次中期分析后，由于血管内治疗的疗效，试验提前终止。90天时，观察到改良Rankin量表评分分布向更好结局偏移，表明血管内治疗优于单纯药物治疗（广义优势比，1.37；95%置信区间，1.11至1.69；P = 0.004）。血管内治疗组230例患者中有14例（6.1%）发生症状性颅内出血，药物治疗管理组225例患者中有6例（2.7%）发生；任何颅内出血分别发生在113例（49.1%）和39例（17.3%）。次要结局的结果总体上支持主要分析结果。