Association Between Clinical Trial Participation Status and Outcomes With Mitral Transcatheter Edge-to-Edge Repair.
JACC Cardiovasc Interv
; 17(4): 520-530, 2024 Feb 26.
Article
em En
| MEDLINE
| ID: mdl-38418055
ABSTRACT
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.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Implante de Prótese de Valva Cardíaca
/
Insuficiência da Valva Mitral
Limite:
Humans
Idioma:
En
Revista:
JACC Cardiovasc Interv
Assunto da revista:
ANGIOLOGIA
/
CARDIOLOGIA
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Estados Unidos