Nogueira Raul G, Haussen Diogo C, Liebeskind David S, Jovin Tudor G, Gupta Rishi, Saver Jeffrey L, Jadhav Ashutosh P, Budzik Ronald F, Baxter Blaise, Krajina Antonin, Bonafe Alain, Malek Ali, Narata Ana Paula, Mohammaden Mahmoud H, Zhang Yanchang, Morgan Patricia, Ji Minyi, Bartolini Bruno, English Joey, Albers Gregory W, Mlynash Michael, Lansberg Maarten G, Frankel Michael R, Pereira Vitor M, Veznedaroglu Erol
Department of Neurology, 12239Emory University School of Medicine, Marcus Stroke & Neuroscience Center, 71741Grady Memorial Hospital, Atlanta, GA, USA.
Department of Neurology and Comprehensive Stroke Center, David Geffen School of Medicine, University of California, Los Angeles (8783UCLA), Los Angeles, CA, USA.
Int J Stroke. 2022 Apr;17(4):389-399. doi: 10.1177/17474930211005740. Epub 2021 Apr 20.
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 > 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), < 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.
多项随机临床试验已明确证实了机械取栓术的临床疗效。然而，这些研究是在精心挑选的中心进行的，并采用了严格的纳入标准。
我们旨在评估一项前瞻性登记研究中机械取栓术的临床有效性。
来自12个国家76个地点的2008例患者被纳入一项前瞻性开放标签机械取栓登记研究。根据基本人口统计学和临床标准，将患者分类到SWIFT-Prime、DAWN和DEFUSE 3试验的相应队列中，而不考虑特定的实质影像学表现。对相应组的基线和结局变量进行比较。
与实际试验中的治疗患者相比，登记研究中的患者往往更年轻，基线ASPECTS更低。此外，DAWN和DEFUSE-3登记研究中的患者与相应试验相比，治疗时间更早，静脉注射组织纤溶酶原激活剂（IV-tPA）和全身麻醉的使用率更高。登记研究中的患者再灌注率更高。登记研究中患者90天良好结局（改良Rankin量表（mRS）0-2）的发生率与相应随机临床试验中治疗的患者相当（SWIFT-Prime，64.5%对60.2%；DAWN，50.4%对48.6%；Beyond-DAWN：52.4%对48.6%；DEFUSE 3，52%对44.6%，均>0.05）。登记研究中的患者残疾程度明显低于相应随机临床试验对照组（序数改良Rankin量表（mRS）移位优势比（OR），均<0.05）。
我们的研究为取栓术在“现实世界”环境中的安全性和有效性提供了有利的可推广性数据，并支持在随机临床试验的限制之外可以安全地治疗患者。
