• Feng Gao, Xu Tong, Baixue Jia, Ming Wei, Yuesong Pan, Ming Yang, Dapeng Sun, Thanh N Nguyen, Zeguang Ren, Francis Demiraj, Xiaoxi Yao, Chenghua Xu, Guangxiong Yuan, Yue Wan, Jianjun Tang, Jing Wang, Yuanfei Jiang, Chaobin Wang, Xiang Luo, Haihua Yang, Ruile Shen, Zhilin Wu, Zhengzhou Yuan, Dongjun Wan, Wei Hu, Yan Liu, Ping Jing, Liping Wei, Tuanyuan Zheng, Yingchun Wu, Xinguang Yang, Yaxuan Sun, Changming Wen, Mingze Chang, Bo Yin, Di Li, Jixin Duan, Dianjing Sun, Zaiyu Guo, Guodong Xu, Guoqing Wang, Liyu Wang, Yang Wang, Weihua Jia, Gaoting Ma, Xiaochuan Huo, Dapeng Mo, Ning Ma, Liping Liu, Xingquan Zhao, Yilong Wang, Jens Fiehler, Yongjun Wang, and Zhongrong Miao.
• Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
• Lancet Neurol. 2024 Aug 1; 23 (8): 797806797-806.

BackgroundUnsuccessful recanalisation or reocclusion after thrombectomy is associated with poor outcomes in patients with large vessel occlusion (LVO) acute ischaemic stroke (LVO-AIS). Bailout angioplasty or stenting (BAOS) could represent a promising treatment for these patients. We conducted a randomised controlled trial with the aim to investigate the safety and efficacy of BAOS following thrombectomy in patients with LVO.MethodsANGEL-REBOOT was an investigator-initiated, multicentre, prospective, randomised, controlled, open-label, blinded-endpoint clinical trial conducted at 36 tertiary hospitals in 19 provinces in China. Participants with LVO-AIS 24 h after symptom onset were eligible if they had unsuccessful recanalisation (expanded Thrombolysis In Cerebral Infarction score of 0-2a) or risk of reocclusion (residual stenosis >70%) after thrombectomy. Eligible patients were randomly assigned by the minimisation method in a 1:1 ratio to undergo BAOS as the intervention treatment, or to receive standard therapy (continue or terminate the thrombectomy procedure) as a control group, both open-label. In both treatment groups, tirofiban could be recommended for use during and after the procedure. The primary outcome was the change in modified Rankin Scale score at 90 days, assessed in the intention-to-treat population. Safety outcomes were compared between groups. This trial was completed and registered at ClinicalTrials.gov (NCT05122286).FindingsFrom Dec 19, 2021, to March 17, 2023, 706 patients were screened, and 348 were enrolled, with 176 assigned to the intervention group and 172 to the control group. No patients withdrew from the trial or were lost to follow-up for the primary outcome. The median age of patients was 63 years (IQR 55-69), 258 patients (74%) were male, and 90 patients (26%) were female; all participants were Chinese. After random allocation, tirofiban was administered either intra-arterially, intravenously, or both in 334 [96%] of 348 participants. No between-group differences were observed in the primary outcome (common odds ratio 0·86 [95% CI 0·59-1·24], p=0·41). Mortality was similar between the two groups (19 [11%] of 176 vs 17 [10%] of 172), but the intervention group showed a higher risk of symptomatic intracranial haemorrhage (eight [5%] of 175 vs one [1%] of 169), parenchymal haemorrhage type 2 (six [3%] of 175 vs none in the control group), and procedure-related arterial dissection (24 [14%] of 176 vs five [3%] of 172).InterpretationAmong Chinese patients with unsuccessful recanalisation or who are at risk of reocclusion after thrombectomy, BAOS did not improve clinical outcome at 90 days, and incurred more complications compared with standard therapy. The off-label use of tirofiban might have affected our results and their generalisability, but our findings do not support the addition of BAOS for such patients with LVO-AIS.FundingBeijing Natural Science Foundation, National Natural Science Foundation of China, National Key R&D Program Beijing Municipal Administration of Hospitals Incubating Program, Shanghai HeartCare Medical Technology, HeMo (China) Bioengineering, Sino Medical Sciences Technology.Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

27 keywords...

hide…