Useless because you are not measuring 100% recovery. THAT IS THE ONLY EFFECTIVENESS ENDPOINT.
EXPRESS: Clinical Effectiveness of Endovascular Stroke Treatment in the Early and Extended Time Windows
Abstract
Background
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.
Aim
We aimed to assess the clinical effectiveness of MT in 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 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 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 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.(Safety is NOT GOOD ENOUGH. Will you please work on the only goal in stroke? 100% recovery.)
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