Valvular & structural heart diseaseCohort study
Transcatheter Edge-to-Edge Repair in 5,000 Patients With Secondary Mitral Regurgitation
- Prospective observational single-arm study
- multicentre
- 406 US centres
- TVT registry
Authors' conclusion
This large, contemporary, real-world study reinforces the safety and effectiveness of the MitraClip System in patients with SMR, including those who met the COAPT or MITRA-FR RCT inclusion/exclusion criteria and patients excluded from the RCTs.
Study context
- Population
- Consecutive patients with secondary mitral regurgitation treated with MitraClip at US centres, 2019–2020
- Participants
- 5,000 consecutive patients
- Exposure
- COAPT-PAS vs COAPT-like vs MITRA-FR-like
- COAPT-liken = 991
- MITRA-FR-liken = 917
- Outcome
- Safety and effectiveness of MitraClip (1-year outcomes)
- Follow-up
- 1 year
Main finding
As reported in the abstract
MR reduction to ≤2+
- MitraClip implant rate
- 97.7%
Observational data: associations, not effects.
Further findings
HF hospitalisation · 1 year
| Outcome | COAPT-PAS | COAPT-like | MITRA-FR-like |
|---|---|---|---|
| KCCQ improvement · 1 year | +29 | +27 | +33 |
- HF hospitalisation — COAPT-RCT
- 24.9%
- HF hospitalisation — MITRA-FR-RCT
- 47.4%
Clinical event rates vs randomized controlled trial (RCTs)
- Similar or lower than the RCTs' MitraClip arms; lower than the RCTs' GDMT-only arms; faster procedure times
Original publication
Transcatheter Edge-to-Edge Repair in 5,000 Patients With Secondary Mitral Regurgitation. J Am Coll Cardiol. Published 26 September 2023. doi:10.1016/j.jacc.2023.07.015
Summarised from the published abstract; every number is checked against it