当前位置: 首页 > 详情页

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

文献详情

资源类型:
WOS体系:
Pubmed体系:

收录情况: ◇ SCIE

机构: [1]Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Intervent Neuroradiol, Beijing 100070, Peoples R China [2]Tianjin Huanhu Hosp, Dept Neurosurg, Tianjin, Peoples R China [3]China Natl Clin Res Ctr Neurol Dis, Beijing 100070, Peoples R China [4]Boston Med Ctr, Dept Radiol, Boston, MA USA [5]Boston Med Ctr, Dept Neurol, Boston, MA USA [6]Florida Atlantic Univ, Schmidt Coll Med, Dept Neurol, Boca Raton, FL USA [7]First Peoples Hosp Chenzhou, Dept Neurol, Chenzhou, Peoples R China [8]First Peoples Hosp Taizhou, Dept Neurol, Taizhou, Peoples R China [9]Xiangtan Cent Hosp, Dept Emergency, Xiangtan, Peoples R China [10]Third Peoples Hosp Hubei Prov, Dept Neurol, Wuhan, Peoples R China [11]Shanghai Neuromed Ctr, Dept Neurol, Shanghai, Peoples R China [12]Beijing Fengtai Youanmen Hosp, Dept Neurointervent Radiol, Beijing, Peoples R China [13]Taian Hosp Chinese Med, Dept Neurol, Tai An, Peoples R China [14]Beijing Liangxiang Hosp, Dept Neurol, Beijing, Peoples R China [15]Tongji Hosp, Tongji Med Coll HUST, Dept Neurol, Wuhan, Peoples R China [16]Beijing Daxing Peoples Hosp, Dept Neurol, Beijing, Peoples R China [17]Henan Univ Sci & Technol, Affiliated Hosp 1, Dept Neurol, Luoyang, Peoples R China [18]YunFu Peoples Hosp, Dept Neurointervent Radiol, Yunfu, Peoples R China [19]Southwest Med Univ, Affiliated Hosp, Dept Neurol, Luzhou, Peoples R China [20]940th Hosp Joint Logist Support force Chinese Peop, Dept Neurol, Lanzhou, Peoples R China [21]Univ Sci & Technol China, Affiliated Hosp USTC 1, Dept Neurol, Div Life Sci & Med, Hefei, Peoples R China [22]Yangzhou Univ, JingJiang Peoples Hosp, Affiliated Hosp 7, Dept Neurol, Jingjiang, Peoples R China [23]Wuhan Cent Hosp, Dept Neurol, Wuhan, Peoples R China [24]Luoyang Cent Hosp, Dept Neurol, Luoyang, Peoples R China [25]JiuJiang First Peoples Hosp, Dept Neurol, Jiujiang, Peoples R China [26]Ordos Cent Hosp, Dept Neurol, Ordos, Peoples R China [27]Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Dept Neurol, Guangzhou, Peoples R China [28]Shanxi Prov Peoples Hosp, Dept Neurol, Taiyuan, Peoples R China [29]Nanyang Cent Hosp, Dept Neurol, Nanyang, Peoples R China [30]Northwest Univ, Xian Hosp 3, Dept Neurol, Affiliated Hosp, Xian, Peoples R China [31]Wenzhou Med Univ, Affiliated Hosp 2, Dept Neurosurg, Wenzhou, Peoples R China [32]Dalian Med Univ, Dalian Municipal Cent Hosp, Dept Neurointervent Radiol, Dalian, Peoples R China [33]Changsha Hosp Tradit Chinese Med, Dept Neurosurg, Changsha, Peoples R China [34]Yantai Mt Hosp Yantai City, Dept Neurointervent Radiol, Yantai, Peoples R China [35]Tianjin TEDA Hosp, Ctr Neurol, Tianjin, Peoples R China [36]Heibei Prov Peoples Hosp, Dept Neurointervent Radiol, Shijiazhuang, Peoples R China [37]Binzhou Peoples Hosp, Dept Neurol, Binzhou, Peoples R China [38]Beijing Shunyi Hosp, Dept Neurointervent Radiol, Beijing, Peoples R China [39]Capital Med Univ, Beijing Chaoyang Hosp, Dept Neurosurg, Beijing, Peoples R China [40]Beijing Shijingshan Hosp, Dept Neurol, Beijing, Peoples R China [41]Capital Med Univ, Xuanwu Hosp, Dept Neurol, Beijing, Peoples R China [42]Capital Med Univ, Beijing Anzhen Hosp, Neurol Dis Ctr, Beijing, Peoples R China [43]Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Beijing, Peoples R China [44]Univ Med Ctr Hamburg Eppendorf, Dept Diagnost & Intervent Neuroradiol, Hamburg, Germany
出处:
ISSN:

摘要:
Background 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. Methods ANGEL-REBOOT was an investigator-initiated, multicentre, prospective, randomised, controlled, openlabel, 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 openlabel. 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). Findings 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 intraarterially, intravenously, or both in 334 [96%] of 348 participants. No between-group differences were observed in the primary outcome (common odds ratio 0<middle dot>86 [95% CI 0<middle dot>59-1<middle dot>24], p=0<middle dot>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). Interpretation 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. Funding 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. Copyright (c) 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

基金:
语种:
被引次数:
WOS:
PubmedID:
中科院(CAS)分区:
出版当年[2023]版:
大类 | 1 区 医学
小类 | 1 区 临床神经病学
最新[2025]版:
大类 | 1 区 医学
小类 | 1 区 临床神经病学
JCR分区:
出版当年[2022]版:
Q1 CLINICAL NEUROLOGY
最新[2023]版:
Q1 CLINICAL NEUROLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2022版] 出版当年五年平均 出版前一年[2021版] 出版后一年[2023版]

第一作者:
第一作者机构: [1]Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Intervent Neuroradiol, Beijing 100070, Peoples R China
通讯作者:
通讯机构: [3]China Natl Clin Res Ctr Neurol Dis, Beijing 100070, Peoples R China [43]Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Beijing, Peoples R China [*1]Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China [*2]China National Clinical Research Center for Neurological Diseases, Beijing 100070, China
推荐引用方式(GB/T 7714):
APA:
MLA:

资源点击量:17069 今日访问量:0 总访问量:916 更新日期:2025-04-01 建议使用谷歌、火狐浏览器 常见问题

版权所有©2020 首都医科大学宣武医院 技术支持:重庆聚合科技有限公司 地址:北京市西城区长椿街45号宣武医院