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Randomized Controlled Trial Comparative Study
Trial of Thrombectomy 6 to 24 Hours after Stroke Due to Basilar-Artery Occlusion.
- Tudor G Jovin, Chuanhui Li, Longfei Wu, Chuanjie Wu, Jian Chen, Changchun Jiang, Zhonghua Shi, Zongen Gao, Cunfeng Song, Wenhuo Chen, Ya Peng, Chen Yao, Ming Wei, Tong Li, Liping Wei, Guodong Xiao, Hua Yang, Ming Ren, Jiangang Duan, Xinfeng Liu, Qingwu Yang, Yuxiu Liu, Qingfeng Zhu, Wanchao Shi, Qiyi Zhu, Xiaobo Li, Zaiyu Guo, Qi Yang, Chengbei Hou, Wenbo Zhao, Qingfeng Ma, Yunzhou Zhang, Liqun Jiao, Hongqi Zhang, David S Liebeskind, Hui Liang, Ashutosh P Jadhav, Changming Wen, Scott Brown, Liangfu Zhu, Huawei Ye, Marc Ribo, Mingze Chang, Haiqing Song, Jun Chen, Xunming Ji, and BAOCHE Investigators.
- From the Department of Neurosurgery (T.G.J., Jian Chen, L.J., H.Z., X.J.), the Department of Neurology (C.L., L.W., C.W., W.Z., Q.M., Y.Z., H.S.), the Stroke Center (C.L.), the Department of Emergency Medicine (J.D.), and the Center for Evidence-Based Medicine (C.H.), Xuanwu Hospital, and the Department of Radiology, Beijing Chaoyang Hospital (Q.Y.), Capital Medical University, and Peking University Clinical Research Institute, Peking University First Hospital (C.Y.), Beijing, the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University (C.J.), Baotou, the Department of Neurosurgery, the 904th Hospital of the People's Liberation Army (PLA), Wuxi (Z.S.); the Department of Neurology, Central Hospital of Shengli Oil Field, Dongying (Z.G.), the Department of Neurology, Liaocheng Third People's Hospital, Liaocheng (C.S.), the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, the First People's Hospital of Changzhou, Changzhou (Y.P.), the Department of Neurosurgery, Tianjin Huanhu Hospital (M.W.), the Department of Neurosurgery, Binhai Hospital of Beijing University (W.S.), and the Department of Neurosurgery, Tianjin Teda Hospital (Z.G.), Tianjin, the Department of Neurology, Nanning Second People's Hospital, Nanning (T.L.), the Department of Radiology, Luoyang Central Hospital of Zhengzhou University, Luoyang (L.W.), the Department of Neurology and the Clinical Research Center of Neurologic Disease, Second Affiliated Hospital of Soochow University, Suzhou (G.X.), the Department of Neurosurgery, Affiliated Hospital of Guizhou Medical University, Guiyang (H.Y.), the Department of Neurology, Shanghai Blue Cross Hospital, Shanghai (M.R.), the Department of Neurology (X.L.), and the Department of Critical Care Medicine, Data and Statistics Division (Y.L.), Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing, the Department of Neurology, Xinqiao Hospital and Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing (Q.Y.), the Department of Neurosurgery, 985th Hospital of the PLA, Taiyuan (Qingfeng Zhu), the Department of Neurology, Linyi People's Hospital, Linyi (Qiyi Zhu), the Department of Neurology, Subei People's Hospital, Yangzhou (X.L.), the Department of Neurology, Yantaishan Hospital of Shandong First Medical University, Yantai (H.L.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Cerebrovascular Center, Henan Provincial People's Hospital, Zhengzhou (L.Z.), the Department of Neurosurgery, Hospital of Baoan People's Hospital, Shenzhen (H.Y.), and the Department of Neurology, Xi'an No.3 Hospital, Xi'an (M.C.), - all in China; Cooper University Healthcare and Cooper Medical School of Rowan University (T.G.J.), Camden, NJ; the Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles (D.S.L.); the Department of Neurosurgery, Barrow Neurological Institute, Phoenix, AZ (A.P.J.); Altair Biostatistics, Mooresville, NC (S.B.); the Stroke Unit, Hospital Vall d'Hebrón, Barcelona (M.R.); and the 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 (Jun Chen).
- N. Engl. J. Med. 2022 Oct 13; 387 (15): 137313841373-1384.
BackgroundThe effects and risks of endovascular thrombectomy 6 to 24 hours after stroke onset due to basilar-artery occlusion have not been extensively studied.MethodsIn 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.ResultsA 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.ConclusionsAmong 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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