Bailout intracranial angioplasty or stenting following thrombectomy for acute large vessel occlusion in China (ANGEL-REBOOT): a multicentre, open-label, blinded-endpoint, randomised controlled trial

doi:10.1016/S1474-4422(24)00186-8

科研成果详情

题名	Bailout intracranial angioplasty or stenting following thrombectomy for acute large vessel occlusion in China (ANGEL-REBOOT): a multicentre, open-label, blinded-endpoint, randomised controlled trial
作者	Feng Gao 1; Xu Tong 1; Baixue Jia 1; Ming Wei 2; Yuesong Pan 3; Ming Yang 1; Dapeng Sun 1; Thanh N Nguyen 4; Zeguang Ren 5; Francis Demiraj 6; Xiaoxi Yao 7; Chenghua Xu 8; Guangxiong Yuan 9; Yue Wan 10; Jianjun Tang 11; Jing Wang 12; Yuanfei Jiang 13; Chaobin Wang 14; Xiang Luo 15; Haihua Yang 16; Ruile Shen 17; Zhilin Wu 18; Zhengzhou Yuan 19; Dongjun Wan 20; Wei Hu 21; Yan Liu 22; Ping Jing 23; Liping Wei 24; Tuanyuan Zheng 25; Yingchun Wu 26; Xinguang Yang 27; Yaxuan Sun 28; Changming Wen 29; Mingze Chang 30; Bo Yin31; Di Li 32; Jixin Duan 33; Dianjing Sun 34; Zaiyu Guo 35; Guodong Xu 36; Guoqing Wang 37; Liyu Wang 38; Yang Wang 39; Weihua Jia 40; Gaoting Ma 41; Xiaochuan Huo 42; Dapeng Mo 1; Ning Ma 1; Liping Liu 22; Xingquan Zhao 43; Yilong Wang 44; Jens Fiehler 45; Yongjun Wang 46; Zhongrong Miao 47
发表日期	2024-06-21
发表期刊	The Lancet. Neurology 影响因子和分区
语种	英语
原始文献类型	Journal Article
其他关键词	ACUTE ISCHEMIC-STROKE ; ENDOVASCULAR THROMBECTOMY ; TIROFIBAN
摘要	Unsuccessful 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., ANGEL-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)., From 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)., Among 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., Beijing 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.
资助项目	Beijing Natural Science Foundation[220016];National Natural Science Foundation of China[62272325];National Key R&D Program[2018AAA0102600];Beijing Municipal Administration of Hospitals Incubating Program[PX2023022];
出版者	ELSEVIER SCIENCE INC
ISSN	1474-4422
EISSN	1474-4465
卷号	23 期号:8 页码:797-806
DOI	10.1016/S1474-4422(24)00186-8
页数	10
WOS类目	Clinical Neurology
WOS研究方向	Neurosciences & Neurology
WOS记录号	WOS:001278356800001
收录类别	PUBMED ; SCOPUS ; SCIE
URL	查看原文
PubMed ID	38914085
SCOPUSEID	2-s2.0-85197623148
通讯作者地址	[Miao, Zhongrong]Interventional Neuroradiology,Department of Neurology,Beijing Tiantan Hospital,Capital Medical University,Beijing,100070,China ; [Wang, Yongjun]China National Clinical Research Center for Neurological Diseases,Beijing,100070,China
Scopus学科分类	Neurology (clinical)
引用统计
文献类型	期刊论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/215653
专题	第二临床医学院、附属第二医院、育英儿童医院附属第二医院附属第二医院_神经外科
作者单位	1.Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.; 2.Department of Neurosurgery, Tianjin Huanhu Hospital, Tianjin, China.; 3.Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; China National Clinical Research Center for Neurological Diseases, Beijing, China.; 4.Department of Radiology, Boston Medical Center, Boston, MA, USA; Department of Neurology, Boston Medical Center, Boston, MA, USA.; 5.China National Clinical Research Center for Neurological Diseases, Beijing, China.; 6.Department of Neurology, Florida Atlantic University Schmidt College of Medicine, Boca Raton, FL, USA.; 7.Department of Neurology, The First People's Hospital of Chenzhou, Chenzhou, China.; 8.Department of Neurology, The First People's Hospital of Taizhou, Taizhou, China.; 9.Department of Emergency, Xiangtan Central Hospital, Xiangtan, China.; 10.Department of Neurology, The Third People's Hospital of Hubei Province, Wuhan, China.; 11.Department of Neurology, Shanghai Neuromedical Center, Shanghai, China.; 12.Department of Neurointerventional Radiology, Beijing Fengtai You'anmen Hospital, Beijing, China.; 13.Department of Neurology, Tai'an Hospital of Chinese Medicine, Tai'an, China.; 14.Department of Neurology, Beijing Liangxiang Hospital, Beijing, China.; 15.Department of Neurology, Tongji Hospital, Tongji Medical College of HUST, Wuhan, China.; 16.Department of Neurology, Beijing Daxing People's Hospital, Beijing, China.; 17.Department of Neurology, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China.; 18.Department of Neurointerventional Radiology, YunFu People's Hospital, YunFu, China.; 19.Department of Neurology, The Affiliated Hospital of Southwest Medical University, Luzhou, China.; 20.Department of Neurology, The 940th Hospital of Joint Logistics Support force of Chinese People's Liberation Army, Lanzhou, China.; 21.Department of Neurology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.; 22.Department of Neurology, JingJiang People's Hospital, The Seventh Affiliated Hospital of Yangzhou University, JingJiang, China.; 23.Department of Neurology, Wuhan Central Hospital, Wuhan, China.; 24.Department of Neurology, Luoyang Central Hospital, Luoyang, China.; 25.Department of Neurology, JiuJiang First People's Hospital, JiuJiang, China.; 26.Department of Neurology, Ordos Central Hospital, Ordos, China.; 27.Department of Neurology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.; 28.Department of Neurology, Shanxi Provincial People's Hospital, Taiyuan, China.; 29.Department of Neurology, Nanyang Central Hospital, Nanyang, China.; 30.Department of Neurology, Xi'an Third Hospital, The Affiliated Hospital of Northwest University, Xi'an, China.; 31.Department of Neurosurgery, The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.; 32.Department of Neurointerventional Radiology, Dalian Municipal Central Hospital, Dalian Medical University, Dalian, China.; 33.Department of Neurosurgery, Changsha Hospital of Traditional Chinese Medicine, Changsha, China.; 34.Department of Neurointerventional Radiology, Yantai Mountain Hospital of Yantai City, Yantai, China.; 35.Center for Neurology, Tianjin TEDA Hospital, Tianjin, China.; 36.Department of Neurointerventional Radiology, Heibei Provincial People's Hospital, Shijiazhuang, China.; 37.Department of Neurology, Binzhou People's Hospital, Binzhou, China.; 38.Department of Neurointerventional Radiology, Beijing Shunyi Hospital, Beijing, China.; 39.Department of Neurosurgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.; 40.Department of Neurology, Beijing Shijingshan Hospital, Beijing, China.; 41.Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.; 42.Neurological Disease Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.; 43.Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.; 44.China National Clinical Research Center for Neurological Diseases, Beijing, China; Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.; 45.Department of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.; 46.China National Clinical Research Center for Neurological Diseases, Beijing, China; Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. Electronic address: yongjunwang@ncrcnd.org.cn.; 47.Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. Electronic address: zhongrongm@163.com.
推荐引用方式 GB/T 7714	Feng Gao,Xu Tong,Baixue Jia,et al. Bailout intracranial angioplasty or stenting following thrombectomy for acute large vessel occlusion in China (ANGEL-REBOOT): a multicentre, open-label, blinded-endpoint, randomised controlled trial[J]. The Lancet. Neurology,2024,23(8):797-806.
APA	Feng Gao., Xu Tong., Baixue Jia., Ming Wei., Yuesong Pan., ... & Zhongrong Miao. (2024). Bailout intracranial angioplasty or stenting following thrombectomy for acute large vessel occlusion in China (ANGEL-REBOOT): a multicentre, open-label, blinded-endpoint, randomised controlled trial. The Lancet. Neurology, 23(8), 797-806.
MLA	Feng Gao,et al."Bailout intracranial angioplasty or stenting following thrombectomy for acute large vessel occlusion in China (ANGEL-REBOOT): a multicentre, open-label, blinded-endpoint, randomised controlled trial".The Lancet. Neurology 23.8(2024):797-806.