The Journal of thoracic and cardiovascular surgery
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J. Thorac. Cardiovasc. Surg. · Apr 2020
Randomized Controlled Trial Multicenter StudyInter- and intrasite variability of mortality and stroke for sites performing both surgical and transcatheter aortic valve replacement for aortic valve stenosis in intermediate-risk patients.
Multisite procedure-based randomized trials may be confounded by performance variability and variability among sites. Therefore, we studied variability in mortality and stroke after patients were randomized to surgical (SAVR) or transcatheter aortic valve replacement (TAVR) in the Placement of Aortic Transcatheter Valves-2A (PARTNER-2A) randomized trial. ⋯ Intersite variability was similar for mortality in SAVR and TAVR, but variability for stroke was greater for SAVR than for TAVR. Intrasite events were similar for both SAVR and TAVR. These findings suggest that in performance-based trials, site variability and its sources should be taken into account in analyzing and interpreting trial results.