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Clinical effectiveness of endovascular stroke treatment in the early and extended time windows

医学 临床试验 改良兰金量表 随机对照试验 冲程(发动机) 优势比 前瞻性队列研究 内科学 外科 缺血性中风 机械工程 缺血 工程类
作者
Raul G. Nogueira,Diogo C Haussen,David S. Liebeskind,Tudor Jovin,Rishi Gupta,Jeffrey L. Saver,Ashutosh P. Jadhav,Ronald F. Budzik,Blaise Baxter,Antonı́n Krajina,Alain Bonafé,Ali Malek,Ana Paula Narata,Mahmoud Mohammaden,Yanchang Zhang,Patricia M. Morgan,Minyi Ji,Bruno Bartolini,Joey English,Gregory W. Albers
出处
期刊:International Journal of Stroke [SAGE Publishing]
卷期号:17 (4): 389-399 被引量:14
标识
DOI:10.1177/17474930211005740
摘要

The clinical efficacy of mechanical thrombectomy has been unequivocally demonstrated in multiple randomized clinical trials. However, these studies were performed in carefully selected centers and utilized strict inclusion criteria.We aimed to assess the clinical effectiveness of mechanical thrombectomy in a prospective registry.A total of 2008 patients from 76 sites across 12 countries were enrolled in a prospective open-label mechanical thrombectomy registry. Patients were categorized into the corresponding cohorts of the SWIFT-Prime, DAWN, and DEFUSE 3 trials according to the basic demographic and clinical criteria without considering specific parenchymal imaging findings. Baseline and outcome variables were compared across the corresponding groups.As compared to the treated patients in the actual trials, registry-derived patients tended to be younger and had lower baseline ASPECTS. In addition, time to treatment was earlier and the use of intravenous tissue plasminogen activator (IV-tPA) and general anesthesia were higher in DAWN- and DEFUSE-3 registry derived patients versus their corresponding trials. Reperfusion rates were higher in the registry patients. The rates of 90-day good outcome (mRS0-2) in registry-derived patients were comparable to those of the patients treated in the corresponding randomized clinical trials (SWIFT-Prime, 64.5% vs. 60.2%; DAWN, 50.4% vs. 48.6%; Beyond-DAWN: 52.4% vs. 48.6%; DEFUSE 3, 52% vs. 44.6%, respectively; all P > 0.05). Registry-derived patients had significant less disability than the corresponding randomized clinical trial controls (ordinal modified Rankin Scale (mRS) shift odds ratio (OR), P < 0.05 for all).Our study provides favorable generalizability data for the safety and efficacy of thrombectomy in the "real-world" setting and supports that patients may be safely treated outside the constraints of randomized clinical trials.
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