Valvular & structural heart diseaseCohort study
Association Between Clinical Trial Participation Status and Outcomes With Mitral Transcatheter Edge-to-Edge Repair
- Retrospective cohort study
- National Inpatient Sample database
- multivariate regression
Authors' conclusion
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.
Study context
- Population
- Admissions for mitral transcatheter edge-to-edge repair (M-TEER), US National Inpatient Sample, 2016–2020
- Participants
- 38,770 M-TEER admissions
- Exposure
- Trial vs Eligible nonparticipants vs Noneligible
- Trialn = 11,450reference
- Eligible nonparticipantsn = 22,975
- Noneligiblen = 2,960
- Outcome
- In-hospital mortality
- Follow-up
- In-hospital
Main finding
As reported in the abstract
Adjusted odds ratio (95% CI)
Trial vs Eligible nonparticipants
0.98(0.60–1.62)
Noneligible vs Trial
6.27(3.75–10.45)
Observational data: associations, not effects.
Secondary outcomes
| Outcome | aOR (95% CI) | |
|---|---|---|
| In-hospital complications (trial participants vs eligible nonparticipants) — Trial vs Eligible nonparticipants · cardiogenic shock | 1.06 (0.80–1.42) | |
| In-hospital complications (trial participants vs eligible nonparticipants) — Trial vs Eligible nonparticipants · mechanical circulatory support | 0.91 (0.58–1.41) | |
| In-hospital complications (trial participants vs eligible nonparticipants) — Trial vs Eligible nonparticipants · mechanical ventilation | 1.03 (0.74–1.42) | |
| In-hospital complications (trial participants vs eligible nonparticipants) — Trial vs Eligible nonparticipants · conversion to mitral valve surgery | 1.08 (0.57–2.03) | |
| 0.512Adjusted odds ratio (log scale) |
Complications (noneligible vs trial participants)
- Higher rates of complications in noneligible patients
Original publication
Association Between Clinical Trial Participation Status and Outcomes With Mitral Transcatheter Edge-to-Edge Repair. JACC Cardiovasc Interv. Published 26 February 2024. doi:10.1016/j.jcin.2023.10.063
Summarised from the published abstract; every number is checked against it