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Randomized Controlled Trial
. 2022 Apr;17(4):389-399.
doi: 10.1177/17474930211005740. Epub 2021 Apr 20.

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

Raul G Nogueira  1 , Diogo C Haussen  1 , David S Liebeskind  2 , Tudor G Jovin  3 , Rishi Gupta  4 , Jeffrey L Saver  2 , Ashutosh P Jadhav  5 , Ronald F Budzik  6 , Blaise Baxter  7 , Antonin Krajina  8 , Alain Bonafe  9 , Ali Malek  10 , Ana Paula Narata  11 , Mahmoud H Mohammaden  1 , Yanchang Zhang  12 , Patricia Morgan  12 , Minyi Ji  12 , Bruno Bartolini  13 , Joey English  14 , Gregory W Albers  15 , Michael Mlynash  15 , Maarten G Lansberg  15 , Michael R Frankel  1 , Vitor M Pereira  16 , Erol Veznedaroglu  17 ; Trevo Registry, SWIFT Prime, DEFUSE 3 and DAWN Trial Investigators
Affiliations
Randomized Controlled Trial

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

Raul G Nogueira et al. Int J Stroke. 2022 Apr.

Abstract

Background: 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.

Aim: We aimed to assess the clinical effectiveness of mechanical thrombectomy in a prospective registry.

Methods: 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.

Results: 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).

Conclusion: 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.

Keywords: Stroke; registry; thrombectomy.

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