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Trial of Thrombectomy 6 to 24 Hours after Stroke Due to Basilar-Artery Occlusion

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机构: [1]Department of Neurosurgery,Xuanwu Hospital [2]Department of Neurology,Xuanwu Hospital [3]Stroke Center,Xuanwu Hospital [4]Department of Emergency Medicine,Xuanwu Hospital [5]Center for Evidence-Based Medicine,Xuanwu Hospital [6]Department of Radiology, Beijing Chaoyang Hospital,Capital Medical University, [7]Peking University Clinical Research Institute, Peking University First Hospital,Beijing [8]Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University,Baotou [9]Department of Neurosurgery, the 904th Hospital of the People’s Liberation Army (PLA), Wuxi [10]the Department of Neurology, Central Hospital of Shengli Oil Field, Dongying [11]Department of Neurology, Liaocheng Third People’s Hospital, Liaocheng [12]Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou [13]Department of Neurosurgery, the First People’s Hospital of Changzhou, Changzhou [14]Department of Neurosurgery, Tianjin Huanhu Hospital [15]Department of Neurosurgery, Binhai Hospital of Beijing University [16]Department of Neurosurgery, Tianjin Teda Hospital,Tianjin, [17]Department of Neurology, Nanning Second People’s Hospital, Nanning [18]Department of Radiology, Luoyang Central Hospital of Zhengzhou University, Luoyang [19]Department of Neurology and the Clinical Research Center of Neurologic Disease, Second Affiliated Hospital of Soochow University, Suzhou [20]Department of Neurosurgery, Affiliated Hospital of Guizhou Medical University, Guiyang [21]Department of Neurology, Shanghai Blue Cross Hospital, Shanghai [22]Department of Neurology,Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing [23]Department of Critical Care Medicine, Data and Statistics Division,Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing [24]Department of Neurology, Xinqiao Hospital and Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing [25]Department of Neurosurgery, 985th Hospital of the PLA, Taiyuan [26]Department of Neurology, Linyi People’s Hospital, Linyi [27]Department of Neurology, Subei People’s Hospital, Yangzhou [28]Department of Neurology, Yantaishan Hospital of Shandong First Medical University, Yantai [29]Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang [30]Cerebrovascular Center, Henan Provincial People’s Hospital, Zhengzhou [31]Department of Neurosurgery, Hospital of Baoan People’s Hospital, Shenzhen [32]Department of Neurology, Xi’an No.3 Hospital, Xi’an (M.C.), — all in China [33]Cooper University Healthcare and Cooper Medical School of Rowan University,Camden, NJ [34]the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles [35]the Department of Neurosurgery, Barrow Neurological Institute, Phoenix, AZ [36]Altair Biostatistics, Mooresville, NC [37]Stroke Unit, Hospital Vall d’Hebrón, Barcelona [38]Department of Neurology, Pittsburgh Institute of Brain Disorder and Recovery, University of Pittsburgh Medical Center and Veterans Affairs Pittsburgh Health Care System, Geriatric Research Education and Clinical Center, Pittsburgh
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The effects and risks of endovascular thrombectomy 6 to 24 hours after stroke onset due to basilar-artery occlusion have not been extensively studied.In a trial conducted over a 5-year period in China, we randomly assigned, in a 1:1 ratio, patients with basilar-artery stroke who presented between 6 to 24 hours after symptom onset to receive either medical therapy plus thrombectomy or medical therapy only (control). The original primary outcome, a score of 0 to 4 on the modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 4 moderately severe disability, and 6 death) at 90 days, was changed to a good functional status (a modified Rankin scale score of 0 to 3, with a score of 3 indicating moderate disability). Primary safety outcomes were symptomatic intracranial hemorrhage at 24 hours and 90-day mortality.A total of 217 patients (110 in the thrombectomy group and 107 in the control group) were included in the analysis; randomization occurred at a median of 663 minutes after symptom onset. Enrollment was halted at a prespecified interim analysis because of the superiority of thrombectomy. Thrombolysis was used in 14% of the patients in the thrombectomy group and in 21% of those in the control group. A modified Rankin scale score of 0 to 3 (primary outcome) occurred in 51 patients (46%) in the thrombectomy group and in 26 (24%) in the control group (adjusted rate ratio, 1.81; 95% confidence interval [CI], 1.26 to 2.60; P<0.001). The results for the original primary outcome of a modified Rankin scale score of 0 to 4 were 55% and 43%, respectively (adjusted rate ratio, 1.21; 95% CI, 0.95 to 1.54). Symptomatic intracranial hemorrhage occurred in 6 of 102 patients (6%) in the thrombectomy group and in 1 of 88 (1%) in the control group (risk ratio, 5.18; 95% CI, 0.64 to 42.18). Mortality at 90 days was 31% in the thrombectomy group and 42% in the control group (adjusted risk ratio, 0.75; 95% CI, 0.54 to 1.04). Procedural complications occurred in 11% of the patients who underwent thrombectomy.Among patients with stroke due to basilar-artery occlusion who presented 6 to 24 hours after symptom onset, thrombectomy led to a higher percentage with good functional status at 90 days than medical therapy but was associated with procedural complications and more cerebral hemorrhages. (Funded by the Chinese National Ministry of Science and Technology; BAOCHE ClinicalTrials.gov number, NCT02737189.).Copyright © 2022 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
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Q1 MEDICINE, GENERAL & INTERNAL

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第一作者机构: [1]Department of Neurosurgery,Xuanwu Hospital [33]Cooper University Healthcare and Cooper Medical School of Rowan University,Camden, NJ
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通讯机构: [1]Department of Neurosurgery,Xuanwu Hospital [*1]Department of Neurosurgery, Xuanwu Hospital of Capital Medical University, 45 Changchun St., Xi Cheng District, Beijing, 100053, China.
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