Effect of Intravenous Tirofiban vs Placebo Before Endovascular Thrombectomy on Functional Outcomes in Large Vessel Occlusion Stroke: The RESCUE BT Randomized Clinical Trial
机构:[1]Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing 400037, China.[2]Department of Neurology, The 903rd Hospital of The Chinese People's Liberation Army, Hangzhou, China.[3]Department of Neurology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.[4]Department of Cardiovascular diseases, The General Hospital of Tibet Military Area Command, Lhasa, China.[5]Department of Neurology, Wuhan No. 1 Hospital, Wuhan, China.[6]Department of Neurology, Zhongnan Hospital, Wuhan University, Wuhan, China.[7]Department of Neurology, Chinese Medical Hospital of Maoming, Maoming, China.[8]Department of Neurology, Jiangmen Central Hospital, Jiangmen, China.[9]Department of Neurology, Xiangyang No. 1 People's Hospital, Hubei University of Medicine, Xiangyang, China.[10]Department of Neurology, Yijishan Hospital of Wannan Medical College, Wuhu, China.[11]Department of Cerebrovascular Diseases, Leshan People's Hospital, Leshan, China.[12]Department of Neurology, Affiliated Hospital of Southwest Medical University, Luzhou, China.[13]Department of Neurosurgery, Xianyang Hospital of Yan'an University, Xianyang, China.[14]Department of Neurology, Xianyang Hospital of Yan'an University, Xianyang, China.[15]Department of Neurology, Yongchuan Hospital of Chongqing Medical University, Chongqing Key Laboratory of Cerebrovascular Disease Research, Yongchuan, China.[16]Department of Neurology, Wuyi Hospital of Traditional Chinese Medicine, Jiangmen, China.[17]Department of Neurology, Ganzhou People's Hospital, Ganzhou, China.[18]Department of Neurology, Nanyang Central Hospital, Nanyang, China.[19]Department of Emergency, Xiangtan Central Hospital, Xiangtan, China.[20]Department of Neurology, Sichuan Mianyang 404 Hospital, Mianyang, China.[21]Department of Neurology, Longyan First Affliated Hospital of Fujian Medical University, Longyan, China.[22]Department of Neurology, The First Affiliated Hospital of Jilin University, Changchun, China.[23]Department of Neurology, Huainan First People's Hospital, Huainan, China.[24]Department of Neurology, The 924th Hospital of The People's Liberation Army, Guilin, China.[25]Department of Neurology, The Third People's Hospital of Hubei Province, Wuhan, China.[26]Department of Neurology, Chongzhou People's Hospital, Chongzhou, China.[27]Department of Neurology, Qianxinan People's Hospital, Xingyi, China.[28]Department of Neurology, Xi'an Third Hospital, Xi'an, China.[29]Department of Neurosurgery, The 904th Hospital of The People's Liberation Army, Wuxi, China.[30]Department of Neurology, Kaizhou District People's Hospital, Kaizhou, China.[31]Department of Neurology, Songyuan Jilin Oilfield Hospital, Songyuan, China.[32]Department of Neurology, Shantou Central Hospital, Shantou, China.[33]Department of Neurology, Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University, Luzhou, China.[34]Department of Neurology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.[35]Department of Neurology, Ya'an People's Hospital, Ya'an, China.[36]Department of Neurology, The Third People's Hospital of Zigong, Zigong, China.[37]Department of Cerebrovascular Diseases, Guangyuan Central Hospital, Guangyuan, China.[38]Department of Neurology, Jieyang People's Hospital, Jieyang, China.[39]Department of Neurology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China.[40]Department of Neurology, People's Hospital of Wuhan University, Hubei General Hospital, Wuhan, China.[41]Department of Neurology, Chongqing University Three Gorges Central Hospital, Wanzhou, China.[42]Department of Neurology, Shanxi Provincial People's Hospital, Taiyuan, China.[43]Department of Neurology, Jingdezhen First People's Hospital, Jingdezhen, China.[44]Department of Neurointervention, Luoyang Central Hospital, Luoyang, China.[45]Department of Neurology, Xuzhou Central Hospital, Xuzhou, China.[46]Department of Neurology, The First Affiliated Hospital of Henan Science and Technology University, Luoyang, China.[47]Department of Neurology, The First People's Hospital of Yunnan Province, Kunming, China.内科片神经内科云南省第一人民医院[48]Department of Neurology, The First Affiliated Hospital of University of Science and Technology of China, Hefei, China.[49]Department of Neurology, Danzhai County People's Hospital, Danzhai, China.[50]Department of Neurology, Banan District People's Hospital, Banan, China.[51]Department of Neurology, The Affiliated Hospital of Yangzhou University, Yangzhou, China.[52]Department of Neurology, The Fifth People's Hospital of Chengdu, Chengdu, China.[53]Department of Neurology, Jiangxi Provincial People's Hospital, Nanchang, China.[54]Department of Neurology, The 902nd Hospital of The People's Liberation Army, Bengbu, China.[55]Department of Neurology, The First Affiliated Hospital of Shandong First Medical University, Jinan, China.[56]Department of Neurology, Sichuan Provincial People's Hospital, Chengdu, China.四川省人民医院[57]Department of Neurology, Xiangyang Central Hospital, Hubei Arts and Science University, Xiangyang, China.[58]Department of Neurology, Sir Run Run Shaw Hospital affiliated to Zhejiang University, Hangzhou, China.[59]School of Public Health, Shanghai JiaoTong University School of Medicine, Shanghai, China.[60]Department of Neurology, David Geffen School of Medicine at UCLA, Los Angeles, California.[61]Department of Neurology, Marcus Stroke & Neuroscience Centre, Grady Memorial Hospital, Emory University School of Medicine, Atlanta, Georgia.中山大学附属第二医院[62]Chongqing Institute for Brain and Intelligence, Guangyang Bay Laboratory, Chongqing 400064, China.
Tirofiban is a highly selective nonpeptide antagonist of glycoprotein IIb/IIIa receptor, which reversibly inhibits platelet aggregation. It remains uncertain whether intravenous tirofiban is effective to improve functional outcomes for patients with large vessel occlusion ischemic stroke undergoing endovascular thrombectomy.To assess the efficacy and adverse events of intravenous tirofiban before endovascular thrombectomy for acute ischemic stroke secondary to large vessel occlusion.This investigator-initiated, randomized, double-blind, placebo-controlled trial was implemented at 55 hospitals in China, enrolling 948 patients with stroke and proximal intracranial large vessel occlusion presenting within 24 hours of time last known well. Recruitment took place between October 10, 2018, and October 31, 2021, with final follow-up on January 15, 2022.Participants received intravenous tirofiban (n = 463) or placebo (n = 485) prior to endovascular thrombectomy.The primary outcome was disability level at 90 days as measured by overall distribution of the modified Rankin Scale scores from 0 (no symptoms) to 6 (death). The primary safety outcome was the incidence of symptomatic intracranial hemorrhage within 48 hours.Among 948 patients randomized (mean age, 67 years; 391 [41.2%] women), 948 (100%) completed the trial. The median (IQR) 90-day modified Rankin Scale score in the tirofiban group vs placebo group was 3 (1-4) vs 3 (1-4). The adjusted common odds ratio for a lower level of disability with tirofiban vs placebo was 1.08 (95% CI, 0.86-1.36). Incidence of symptomatic intracranial hemorrhage was 9.7% in the tirofiban group vs 6.4% in the placebo group (difference, 3.3% [95% CI, -0.2% to 6.8%]).Among patients with large vessel occlusion acute ischemic stroke undergoing endovascular thrombectomy, treatment with intravenous tirofiban, compared with placebo, before endovascular therapy resulted in no significant difference in disability severity at 90 days. The findings do not support use of intravenous tirofiban before endovascular thrombectomy for acute ischemic stroke.Chinese Clinical Trial Registry Identifier: ChiCTR-IOR-17014167.
基金:
Lunan Pharmaceutical Group Co, Ltd, National
Natural Science Foundation of China (No.
82090040, 81901236, 82071323, and 81801157),
and Army Medical University Clinical Medical
Research Talent Training Program (No.
2019XLC2008 and 2019XLC3016).
第一作者机构:[1]Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing 400037, China.[2]Department of Neurology, The 903rd Hospital of The Chinese People's Liberation Army, Hangzhou, China.
共同第一作者:
通讯作者:
通讯机构:[1]Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing 400037, China.[62]Chongqing Institute for Brain and Intelligence, Guangyang Bay Laboratory, Chongqing 400064, China.[*1]Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), No. 183 Xinqiao Main St, Shapingba District, Chongqing 400037, China,Chongqing Institute for Brain and Intelligence, Guangyang Bay Laboratory, Chongqing 400064, China[*2]Department of Neurology, Xinqiao Hospital and The Second Affiliated Hospital, Army Medical University (Third Military Medical University), No. 183 Xinqiao Main St, Shapingba District, Chongqing 400037, China
推荐引用方式(GB/T 7714):
Qiu Zhongming,Li Fengli,Sang Hongfei,et al.Effect of Intravenous Tirofiban vs Placebo Before Endovascular Thrombectomy on Functional Outcomes in Large Vessel Occlusion Stroke: The RESCUE BT Randomized Clinical Trial[J].JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.2022,328(6):543-553.doi:10.1001/jama.2022.12584.
APA:
Qiu Zhongming,Li Fengli,Sang Hongfei,Luo Weidong,Liu Shuai...&RESCUE BT Trial Investigators.(2022).Effect of Intravenous Tirofiban vs Placebo Before Endovascular Thrombectomy on Functional Outcomes in Large Vessel Occlusion Stroke: The RESCUE BT Randomized Clinical Trial.JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION,328,(6)
MLA:
Qiu Zhongming,et al."Effect of Intravenous Tirofiban vs Placebo Before Endovascular Thrombectomy on Functional Outcomes in Large Vessel Occlusion Stroke: The RESCUE BT Randomized Clinical Trial".JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION 328..6(2022):543-553