Bailout Intracranial Angioplasty or Stenting After Thrombectomy for Acute Large Vessel Occlusion: 1-Year Outcomes of ANGEL-REBOOT
Abstract
BACKGROUND: The long-term benefits of bailout intracranial angioplasty or stenting (BAOS) after thrombectomy in patients with acute large vessel occlusion remain unclear. This study compared BAOS with standard therapy in patients with large vessel occlusion with unsuccessful recanalization (expanded Thrombolysis In Cerebral Infarction score 0–2a) or >70% residual stenosis after thrombectomy. METHODS: ANGEL-REBOOT (Randomized Study of Bailout Intracranial Angioplasty Following Thrombectomy for Acute Large Vessel Occlusion) was a multicenter, open-label, blinded–end point, randomized trial conducted across 36 Chinese hospitals. Patients ≥18 years of age with anterior or posterior circulation large vessel occlusion within 24 hours of stroke onset were enrolled. After identification of thrombectomy failure or high-grade residual stenosis, patients were randomly assigned to the BAOS group (intervention) or the standard therapy group (control), in which thrombectomy was continued or terminated. The use of tirofiban was permitted in both groups during and after the procedure. In the intention-to-treat population, the primary outcome was analyzed using an assumption-free ordinal analysis (Wilcoxon-Mann-Whitney test) to compare the modified Rankin Scale scores (ordinal variable ranging from 0 to 6) between groups at 1-year follow-up, from which the generalized odds ratio was derived. Secondary outcomes included stroke recurrence in the treated artery and all-cause mortality within 1 year, analyzed using Cox proportional hazards models. RESULTS: A total of 348 patients were randomly assigned (176 to the BAOS group and 172 to the standard therapy group) and followed for 90 days, from December 19, 2021, to June 2, 2023. Of these, 326 patients (166 in the BAOS group and 160 in the standard therapy group) completed the 1-year follow-up. Compared with standard therapy, BAOS significantly improved the 1-year modified Rankin Scale score distribution (generalized odds ratio, 1.34 [95% CI, 1.05–1.73]; P =0.02). Fewer stroke recurrences in the treated artery occurred in the BAOS group than in the standard therapy group (7 of 166 [4%] versus 21 of 160 [13%]; hazard ratio, 0.30 [95% CI, 0.13–0.71]; P =0.006). One-year mortality rates were similar between groups (25 of 166 [15%] versus 27 of 160 [17%]; hazard ratio, 0.87 [95% CI, 0.50–1.50]). CONCLUSIONS: Among Chinese patients with large vessel occlusion with unsuccessful recanalization or high-grade residual stenosis after thrombectomy, BAOS was associated with reduced disability and stroke recurrence after 1 year compared with standard therapy. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05122286.
Article Details
Authors (55)
Feng Gao
Xu Tong
Ming Wei
Xiaoxi Yao
Lei Li
Yuesong Pan
Interventional Neuroradiology (F.G., X.T., L. Li, Y.P., B.J., M.Y., Dapeng Sun, D.M., N.M., Z.M.), Capital Medical University, Beijing, China.
Baixue Jia
Thanh N. Nguyen
Department of Neurology, Boston Medical Center, Boston University School of Medicine, Boston
Ming Yang
Dapeng Sun
Ganghua Feng
Department of Neurology, the First People’s Hospital of Chenzhou, Chenzhou, China
Guangxiong Yuan
Emergency Department, Xiangtan Central Hospital (Affiliated Hospital of Hunan University), Xiangtan, China
Chenghua Xu
Department of Neurology, The First People’s Hospital of Taizhou, China (C.X.).
Zhengzhou Yuan
Department of Neurology, The Affiliated Hospital of Southwest Medical University, Luzhou, China (Z.Y.).
Yue Wan
Department of Chemistry, Institute of Molecular Aggregation Science, School of Science
Jing Wang
Hunan Cancer Hospital Changsha China
Ping Jing
Department of Neurology, Wuhan Central Hospital, China (P.J.).
Xinguang Yang
Department of Neurology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China (X.Y.).
Zhilin Wu
Wei Hu
Yuanfei Jiang
Department of Neurology, Tai’an Hospital of Chinese Medicine, China (Y.J.).
Chaobin Wang
Department of Neurology, Beijing Liangxiang Hospital, China (C. Wang).
Changming Wen
Jianjun Tang
Xiang Luo
Ophthalmology Medical Center, The First Affiliated Hospital of Chongqing Medical University, Chongqing Key Laboratory for the Prevention and Treatment of Major Blinding Eye Diseases, Chongqing Branch (Municipality Division) of National Clinical Research Centre for Ocular Diseases
Yingchun Wu
Ruile Shen
Tuanyuan Zheng
Neurology Department, Jiuliang No. 1 People’s Hospital, Jiujiang, China
Yaxuan Sun
Mingze Chang
Department of Neurology, Xi’an Third Hospital, Xi’an, China
Yan Liu
Yang Haihua
Department of Neurology, Beijing Daxing People’s Hospital, China (H.Y.).
Di Li
State Key Laboratory of Biopharmaceutical Preparation and Delivery, Institute of Process Engineering, Chinese Academy of Sciences, 1 North 2nd Street, Zhongguancun, Haidian District, Beijing 100190, P. R. China
Bo Yin
Beijing National Laboratory for Condensed Matter Physics
Weihua Jia
Dongjun Wan
Guodong Xu
Department of Land Surveying and Geo-Informatics, The Hong Kong Polytechnic University
Zaiyu Guo
Center for Neurology, Tianjin TEDA Hospital, China (Z.G.).
Dianjing Sun
Department of Neurointerventional Radiology, Yantai Mountain Hospital of Yantai City, China (Dianjing Sun).
Yang Wang
Jixin Duan
Department of Neurosurgery, Changsha Hospital of Traditional Chinese Medicine, China (J.D.).
Liyu Wang
Department of Neurointerventional Radiology, Beijing Shunyi Hospital, China (L.W.).
Guoqing Wang
SINOPEC (Beijing) Research Institute of Chemical Industry Co., Ltd.
Liping Wei
Gaoting Ma
Department of Neurology, Xuanwu Hospital (G.M.), Capital Medical University, Beijing, China.
Xiaochuan Huo
Neurological Disease Center, Beijing Anzhen Hospital (X.H.), Capital Medical University, Beijing, China.
Dapeng Mo
Ning Ma
Zeguang Ren
China National Clinical Research Center for Neurological Diseases, Beijing, China (Y.P., Z.R., Yilong Wang, Yongjun Wang).
Liping Liu
Xingquan Zhao
Department of Neurology (L.L., X.Z., Yilong Wang, Yongjun Wang), Capital Medical University, Beijing, China.
Yilong Wang
Children’s Hospital, Zhejiang University School of Medicine
Jens Fiehler
Department of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Yongjun Wang
Zhongrong Miao