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.

Department of Interventional Neuroradiology 24601Riverside Methodist Hospital Ohio Health Research Institute Columbus OH USA

Department of Medical Imaging University of Toronto 26625Toronto Western Hospital Toronto Canada

Department of Neurology 12239Emory University School of Medicine Marcus Stroke and Neuroscience Center 71741Grady Memorial Hospital Atlanta GA USA

Department of Neurology 2202Cooper University Hospital Neurological Institute Camden NJ USA

Department of Neurology 7153California Pacific Medical Center San Francisco CA USA

Department of Neurology and Comprehensive Stroke Center David Geffen School of Medicine University of California Los Angeles Los Angeles CA USA

Department of Neurology Stanford Stroke Center Palo Alto CA USA

Department of Neurology Stroke Institute 6614University of Pittsburgh Medical Center PA USA

Department of Neuroradiology CHU Montpellier France

Department of Neuroradiology CHU Tours France

Department of Neurosciences Drexel Neurosciences Institute Philadelphia PA USA

Department of Neurosciences Wellstar Health System Atlanta GA USA

Department of Radiology Interventional Neuroradiology Unit 30635Lausanne University Hospital Lausanne Switzerland

Department of Radiology Lehigh Valley Health Network Allentown PA USA

Department of Radiology University Hospital Hradec Kralove Czech Republic

St Mary's Medical Center West Palm Beach FL USA

Stryker Neurovascular Fremont CA USA

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