Association Between Clinical Trial Participation Status and Outcomes With Mitral Transcatheter Edge-to-Edge Repair

BACKGROUND Clinical trials have demonstrated the efficacy and safety of mitral transcatheter edge -to -edge repair (M-TEER) for selected patients with severe mitral regurgitation. However, the generalizability of trial results to real -world patients remains uncertain. OBJECTIVES The authors aimed to compare baseline characteristics and in -hospital outcomes among trial participants with nonparticipants undergoing M-TEER. METHODS Using the National Inpatient Sample database years 2016-2020, M-TEER admissions were identified and categorized into trial participants vs none. We also identified a cohort of trial noneligible patients based on clinical exclusion criteria from pivotal trials. Multivariate regression analysis was performed to compare in -hospital outcomes. The primary outcome was in -hospital mortality, and secondary outcomes included in -hospital complications, length of stay, and hospitalization cost. RESULTS Among 38,770 M-TEER admissions from 2016 to 2020, 11,450 (29.5%) were trial participants, 22,975 (59.3%) were eligible nonparticipants, and 2,960 (7.6%) were noneligible. Baseline characteristics and comorbidity profiles were mostly similar between trial participants vs eligible nonparticipants. In -hospital mortality (adjusted OR [aOR]: 0.98; 95% CI: 0.60-1.62), cardiogenic shock (aOR: 1.06; 95% CI: 0.80-1.42), mechanical circulatory support (aOR: 0.91; 95% CI: 0.58-1.41), mechanical ventilation (aOR: 1.03; 95% CI: 0.74-1.42), and conversion to mitral valve surgery (aOR: 1.08; 95% CI: 0.57-2.03) were not different between both groups. Conversely, M-TEER for noneligible patients was associated with higher rates of mortality (aOR: 6.27; 95% CI: 3.75-10.45) and complications. CONCLUSIONS The majority of real -world M-TEER patients would have been eligible for clinical trial participation and had comparable clinical profiles and in -hospital outcomes to trial participants. However, noneligible patients had worse in -hospital outcomes compared with trial participants. (J Am Coll Cardiol Intv 2024;17:520-530) Published by Elsevier on behalf of the American College of Cardiology Foundation.