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Trial of Endovascular Therapy for Acute Ischemic Stroke with Large Infarct

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机构： [1]Interventional Neuroradiology, Department of Neurology,Capital Medical University [2]the Departments of Neurosurgery,Capital Medical University [3]Departments of Neurology,Capital Medical University [4]Beijing Tiantan Hospital, and Beijing Institute for Brain Disorders,Capital Medical University [5]China National Clinical Research Center for Neurological Diseases,Beijing [6]Department of Emergency, Xiangtan Central Hospital, Xiangtan [7]Department of Neurology, First People’s Hospital of Chenzhou, Chenzhou [8]Department of Neurology, Linyi People’s Hospital, Linyi [9]Department of Neurology, Binzhou People’s Hospital, Binzhou [10]Department of Neurosurgery, Liaocheng People’s Hospital, Liaocheng [11]Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou [12]Department of Neurosurgery, Tianjin Huanhu Hospital, Tianjin [13]Department of Neurology, Anyang People’s Hospital, Anyang [14]Department of Neurology, Nanyang Central Hospital, Nanyang [15]Department of Cerebrovascular Disease, Henan Provincial People’s Hospital Zhengzhou University, Zhengzhou [16]Department of Neurology, Yijishan Hospital of Wannan Medical College, Wuhu [17]Department of Neurology, Yancheng Third People’s Hospital, Yancheng [18]Department of Neurology, Lishui Municipal Central Hospital, Lishui [19]Department of Neurology, Taizhou Hospital of Zhejiang Province, Taizhou [20]Department of Neurology, China-Japan Union Hospital of Jilin University, Changchun [21]Department of Neurointervention, Dalian Municipal Central Hospital, Dalian Medical University, Dalian [22]Department of Neurosurgery, Guangdong Provincial Hospital of Chinese Medicine [23]Department of Neurology, Zhongshan City People’s Hospital [24]Department of Neurology, Second Affiliated Hospital of Guangzhou Medical University [25]Guangzhou, the Department of Neurology, Shantou Central Hospital, Shantou [26]Department of Neurology, Shenzhen Hospital, Southern Medical University, Shenzhen [27]Department of Neurology, Maoming People’s Hospital, Maoming [28]Department of Neurology, Baotou Central Hospital, Baotou [29]Department of Neurology, Yongchuan Hospital of Chongqing Medical University, Chongqing [30]Department of Neurology, the Affiliated Hospital of Southwest Medical University, Chengdu [31]Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai [32]Department of Neurosurgery, the Affiliated Hospital of Guizhou Medical University, Guiyang [33]Department of Neurology and Radiology, Boston Medical Center, Boston [34]Department of Neurology, University of California, Los Angeles, Los Angeles [35]Department of Neurosurgery, Division of Surgery, St. Michael’s Hospital, University of Toronto, Toronto

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The role of endovascular therapy for acute stroke with a large infarction has not been extensively studied in differing populations.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.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.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.).Copyright © 2023 Massachusetts Medical Society.

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大类 | 1 区

医学

小类 | 1 区医学：内科

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大类 | 1 区

医学

小类 | 1 区医学：内科

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Q1 MEDICINE, GENERAL & INTERNAL

最新[2023]版：

Q1 MEDICINE, GENERAL & INTERNAL

影响因子： 96.3 最新[2023版] 94.3 最新五年平均 176.082 出版当年[2021版] 125.116 出版当年五年平均 91.253 出版前一年[2020版] 158.5 出版后一年[2022版]

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第一作者机构： [1]Interventional Neuroradiology, Department of Neurology,Capital Medical University [5]China National Clinical Research Center for Neurological Diseases,Beijing

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通讯机构： [1]Interventional Neuroradiology, Department of Neurology,Capital Medical University [3]Departments of Neurology,Capital Medical University [5]China National Clinical Research Center for Neurological Diseases,Beijing [32]Department of Neurosurgery, the Affiliated Hospital of Guizhou Medical University, Guiyang [*1]Department of Neurosurgery, the Affiliated Hospital of Guizhou Medical University, No. 28, Guiyi St., Guiyang, Guizhou 550004, China. [*2]Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, No. 119, South 4th Ring West Rd., Fengtai District, Beijing 100070, China. [*3]Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, No. 119, South 4th Ring West Rd., Fengtai District, Beijing 100070, China.

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Trial of Endovascular Therapy for Acute Ischemic Stroke with Large Infarct