Endovascular treatment versus standard medical treatment for vertebrobasilar artery occlusion (BEST): an open-label, randomised controlled trial,The Lancet Neurology

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Endovascular treatment versus standard medical treatment for vertebrobasilar artery occlusion (BEST): an open-label, randomised controlled trial
The Lancet Neurology ( IF 48.0 ) Pub Date : 2020-02-01 , DOI: 10.1016/s1474-4422(19)30395-3
Xinfeng Liu ₁ , Qiliang Dai ₂ , Ruidong Ye ₂ , Wenjie Zi ₃ , Yuxiu Liu ₄ , Huaiming Wang ₂ , Wusheng Zhu ₂ , Minmin Ma ₂ , Qin Yin ₂ , Min Li ₂ , Xinying Fan ₂ , Wen Sun ₂ , Yunfei Han ₂ , Qiushi Lv ₂ , Rui Liu ₂ , Dong Yang ₂ , Zhonghua Shi ₅ , Dequan Zheng ₆ , Xiaorong Deng ₇ , Yue Wan ₇ , Zhen Wang ₈ , Yu Geng ₉ , Xingyu Chen ₁₀ , Zhiming Zhou ₁₁ , Geng Liao ₁₂ , Ping Jin ₁₃ , Yumin Liu ₁₄ , Xintong Liu ₁₅ , Meng Zhang ₁₆ , Feng Zhou ₁₇ , Hongchao Shi ₁₇ , Yunfeng Zhang ₁₈ , Fuqiang Guo ₁₉ , Congguo Yin ₂₀ , Guozhong Niu ₂₀ , Mei Zhang ₂₁ , Xueli Cai ₂₂ , Qiyi Zhu ₂₃ , Zhonglun Chen ₂₄ , Yingchun Liang ₂₅ , Bing Li ₂₆ , Min Lin ₂₇ , Wei Wang ₂₈ , Haowen Xu ₂₉ , Xinmin Fu ₃₀ , Wenhua Liu ₃₁ , Xiguang Tian ₃₂ , Zili Gong ₃₃ , Haicun Shi ₃₄ , Chuanming Wang ₃₅ , Penghua Lv ₃₆ , Zhonghai Tao ₃₇ , Liangfu Zhu ₃₈ , Shiquan Yang ₃₉ , Wei Hu ₄₀ , Pingzhou Jiang ₄₁ , David S Liebeskind ₄₂ , Vitor M Pereira ₄₃ , Thomas Leung ₄₄ , Bernard Yan ₄₅ , Stephen Davis ₄₅ , Gelin Xu ₂ , Raul G Nogueira ₄₆ ,

Affiliation

Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China; Stroke Center and Department of Neurology, First Affiliated Hospital of University of Science and Technology of China, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.
Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.
Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China; Department of Neurology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.
Department of Medical Statistics, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.
Department of Neurosurgery, 101th Hospital of the People's Liberation Army, Wuxi, China.
Department of Neurology, 175th hospital of the People's Liberation Army, Affiliated Southeast Hospital of Xiamen University, Zhangzhou, China.
Department of Neurology, Hubei Zhongshan Hospital, Hubei, China.
Department of Neurology, Changsha Central Hospital, Changsha, China.
Department of Neurology, Zhejiang Provincial People's Hospital, Hangzhou, China.
Department of Neurology, Affiliated Zhongshan Hospital, Xiamen University, Xiamen, China.
Department of Neurology, Yijishan Hospital of Wannan Medical College, Wuhu, China.
Department of Neurology, Maoming People's Hospital, Maoming, China.
Department of Neurology, Lu'an Affiliated Hospital of Anhui Medical University, Lu'an, China.
Department of Neurology, Zhongnan Hospital of Wuhan University, Wuhan, China.
Department of Neurology, Guangdong No 2 Provincial People's Hospital, Guangzhou, China.
Department of Neurology, Research Institute of Surgery, Daping Hospital, Third Military Medical University, Chongqing, China.
Department of Neurology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
Department of Neurology, Affiliated Hospital of Nantong University, Nantong, China.
Department of Neurology, Sichuan People's Hospital, Chengdu, China.
Department of Neurology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Department of Neurology, First People's Hospital of Huainan, Huainan, China.
Department of Neurology, Lishui Hospital of Zhejiang University, Lishui, China.
Department of Neurology, Linyi People's Hospital, Linyi, China.
Department of Neurology, Mianyang Central Hospital, Mianyang, China.
Department of Neurology, Taian City Central Hospital, Taian, China.
Department of Neurology, Yantai Yuhuangding Hospital, Yantai, China.
Department of Neurology, Fuzhou General Hospital of Nanjing Military Region, Fuzhou, China.
Department of Radiology, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China.
Department of Intervention Neuroradiology, First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Department of Neurology, Xuzhou Central Hospital, Xuzhou, China.
Department of Neurology, Wuhan No 1 Hospital, Wuhan, China.
Department of Neurology, Chinese Armed Police Force Guangdong Armed Police Corps hospital, Guangzhou, China.
Department of Neurology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.
Department of Neurology, Third People's Hospital of Yancheng, Yancheng, China.
Department of Neurology, Shenzhen Nanshan People's Hospital and 6th Affiliated Hospital of Shenzhen University Health Science Center, Shenzhen, China.
Department of Interventional Radiology, Northern Jiangsu People's Hospital, Yangzhou, China.
Department of Neurology, Second Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Cerebrovascular Center, Henan Provincial People's Hospital, Zhengzhou University, Zhengzhou, China.
Department of Neurology, 123rd Hospital of the People's Liberation Army, Bengbu, China.
Stroke Center and Department of Neurology, First Affiliated Hospital of University of Science and Technology of China, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.
Department of Neurology, Yangzhou Hongquan Hospital, Yangzhou, China.
Neurovascular Imaging Research Core and University of California Los Angeles Stroke Center, Department of Neurology, University of California, Los Angeles, CA, USA.
Department of Medical Imaging and Surgery, Toronto Western Hospital, University of Toronto, Toronto, ON, Canada.
Department of Medicine and Therapeutics, Chinese University of Hong Kong, Hong Kong, China.
Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, VIC, Australia.
Department of Neurology, Neurosurgery and Radiology, Emory University School of Medicine, Atlanta, GA, USA.

BACKGROUND Previous randomised trials have shown an overwhelming benefit of mechanical thrombectomy for treating patients with stroke caused by large vessel occlusion of the anterior circulation. Whether endovascular treatment is beneficial for vertebrobasilar artery occlusion remains unknown. In this study, we aimed to investigate the safety and efficacy of endovascular treatment of acute strokes due to vertebrobasilar artery occlusion. METHODS We did a multicentre, randomised, open-label trial, with blinded outcome assessment of thrombectomy in patients presenting within 8 h of vertebrobasilar occlusion at 28 centres in China. Patients were randomly assigned (1:1) to endovascular therapy plus standard medical therapy (intervention group) or standard medical therapy alone (control group). The randomisation sequence was computer-generated and stratified by participating centres. Allocation concealment was implemented by use of sealed envelopes. The primary outcome was a modified Rankin scale (mRS) score of 3 or lower (indicating ability to walk unassisted) at 90 days, assessed on an intention-to-treat basis. The primary safety outcome was mortality at 90 days. Secondary safety endpoints included the rates of symptomatic intracranial haemorrhage, device-related complications, and other severe adverse events. The BEST trial is registered with ClinicalTrials.gov, NCT02441556. FINDINGS Between April 27, 2015, and Sept 27, 2017, we assessed 288 patients for eligibility. The trial was terminated early after 131 patients had been randomly assigned (66 patients to the intervention group and 65 to the control group) because of high crossover rate and poor recruitment. In the intention-to-treat analysis, there was no evidence of a difference in the proportion of participants with mRS 0-3 at 90 days according to treatment (28 [42%] of 66 patients in the intervention group vs 21 [32%] of 65 in the control group; adjusted odds ratio [OR] 1·74, 95% CI 0·81-3·74). Secondary prespecified analyses of the primary outcome, done to assess the effect of crossovers, showed higher rates of mRS 0-3 at 90 days in patients who actually received the intervention compared with those who received standard medical therapy alone in both per-protocol (28 [44%] of 63 patients with intervention vs 13 [25%] of 51 with standard therapy; adjusted OR 2·90, 95% CI 1·20-7·03) and as-treated (36 [47%] of 77 patients with intervention vs 13 [24%] of 54 with standard therapy; 3·02, 1·31-7·00) populations. The 90-day mortality was similar between groups (22 [33%] of 66 patients in the intervention vs 25 [38%] of 65 in the control group; p=0·54) despite a numerically higher prevalence of symptomatic intracranial haemorrhage in the intervention group. INTERPRETATION There was no evidence of a difference in favourable outcomes of patients receiving endovascular therapy compared with those receiving standard medical therapy alone. Results might have been confounded by loss of equipoise over the course of the trial, resulting in poor adherence to the assigned study treatment and a reduced sample size due to the early termination of the study. FUNDING Jiangsu Provincial Special Program of Medical Science.

更新日期：2020-02-01

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