Abstract
Background and Purpose: The clinical efficacy of mechanical thrombectomy (MT) has been unequivocally demonstrated in multiple randomized clinical trials (RCTs). However, these studies were performed in carefully selected centers and utilized strict inclusion criteria. We aim to assess the clinical effectiveness of MT by comparing the specific RCT populations with corresponding patient cohorts derived from a prospective registry. Methods: A total of 2008 patients from 76 sites across 12 countries were enrolled in a prospective open-label MT registry. Patients were categorized into the corresponding cohorts of the SWIFT-Prime, DAWN, and DEFUSE 3 trials based on the age, baseline NIHSS, occlusion site, IV tPA use, pre-morbid mRS and time to treatment criteria used in the RCTs 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 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 (mRS 0-2) in registry-derived patients were comparable to those of the patients treated in the corresponding RCTs (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 RCT controls (ordinal mRS shift 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 RCTs and strict guidelines.
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