Randomised controlled trial
Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation
- Randomised controlled trial
- multicentre
- 78 sites in the US and Canada
- 5-year follow-up
Authors' conclusion
Among patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite guideline-directed medical therapy, transcatheter edge-to-edge repair of the mitral valve was safe and led to a lower rate of hospitalization for heart failure and lower all-cause mortality through 5 years of follow-up than medical therapy alone.
Study context
- Population
- Patients with HF and moderate-to-severe or severe secondary mitral regurgitation, symptomatic despite maximal doses of guideline-directed medical therapy
- Participants
- 614 patients
- Comparison
- Device vs Control
- Devicen = 302
- Controln = 312reference
- Primary endpoint
- All hospitalizations for HF
- Follow-up
- Through 2 years
Further findings
| Outcome | Device | Control | HR (95% CI) | |
|---|---|---|---|---|
| Annualized rate of hospitalization for HF · through 5 years | 33.1% per year | 57.2% per year | 0.53 (0.41–0.68) | |
| All-cause mortality · through 5 years | 57.3% | 67.2% | 0.72 (0.58–0.89) | |
| Death or hospitalization for HF · within 5 years | 73.6% | 91.5% | 0.53 (0.44–0.64) | |
| 0.512Hazard ratio (log scale) |
Safety
- Device-specific safety events · within 5 years
- 1.4% · 4 of 302
- Device-specific safety events: 4 of 293 treated patients
- Device-specific safety events: all events within 30 days after the procedure
Original publication
Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation. N Engl J Med. Published 5 March 2023. doi:10.1056/nejmoa2300213
Summarised from the published abstract; every number is checked against it