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

2019; Elsevier BV; Volume: 19; Issue: 2 Linguagem: Inglês

10.1016/s1474-4422(19)30395-3

1474-4465

Xinfeng Liu, Qiliang Dai, Ruidong Ye, Wenjie Zi, Yuxiu Liu, Huaiming Wang, Wusheng Zhu, Minmin Ma, Qin Yin, Min Li, Xinying Fan, Wen Sun, Yunfei Han, Qiushi Lv, Rui Liu, Dong Yang, Zhonghua Shi, Dequan Zheng, Xiaorong Deng, Yue Wan, Zhen Wang, Yu Geng, Xingyu Chen, Zhiming Zhou, Geng Liao, Ping Jin, Yumin Liu, Xintong Liu, Meng Zhang, Feng Zhou, Hongchao Shi, Yunfeng Zhang, Fuqiang Guo, Congguo Yin, Guozhong Niu, Mei Zhang, Xueli Cai, Qiyi Zhu, Zhonglun Chen, Yingchun Liang, Bing Li, Min Lin, Wei Wang, Haowen Xu, Xinmin Fu, Wenhua Liu, Xiguang Tian, Zili Gong, HaiCun Shi, Chuanming Wang, Penghua Lv, Zhonghai Tao, Liangfu Zhu, Shiquan Yang, Wei Hu, Pingzhou Jiang, David S. Liebeskind, Vítor Mendes Pereira, Thomas Leung, Bernard Yan, Stephen M. Davis, Gelin Xu, Raul G Nogueira, Xinfeng Liu, Gelin Xu, Wusheng Zhu, Minmin Ma, Yunyun Xiong, Wenjie Zi, Qiliang Dai, Huaiming Wang, Ruidong Ye, Yuxiu Liu, Zhonghua Shi, Dequan Zheng, Xiaorong Deng, Yue Wan, Zhen Wang, Yu Geng, Zongjie Shi, Weihong Zheng, Xingyu Chen, Zhiming Zhou, Xianjun Huang, Geng Liao, Ping Jin, Yong Liu, Yumin Liu, Huagang Li, Xintong Liu, Meng Zhang, Feng Zhou, Hongchao Shi, Kaifu Ke, Yunfeng Zhang, Fuqiang Guo, Shu Yang, Congguo Yin, Guozhong Niu, Mei Zhang, Xueli Cai, Qiyi Zhu, Zhonglun Chen, Yingchun Liang, Bing Li, Min Lin, Hang Lin, Wei Wang, Haowen Xu, Xinmin Fu, Wèi Dān, Wenhua Liu, Xiguang Tian, Chen Lin, Zili Gong, HaiCun Shi, Chuanming Wang, Penghua Lv, Zhonghai Tao, Liangqun Rong, Liangfu Zhu, Shuiping Wang, Shiquan Yang, Wei Hu, Pingzhou Jiang, Fan Jin, C. Xing, Haifeng Li, Weiming Yang, Changqing Wang, Yong Zhang, Penghua Lv, Xiaobo Li, Vítor Mendes Pereira, Bernard Yan, David S. Liebeskind, Thomas Leung, Stephen M. Davis, Raul G Nogueira,

Stroke Rehabilitation and Recovery

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.