Heart failure & cardiomyopathiesRandomised controlled trial
Transcatheter Repair versus Mitral-Valve Surgery for Secondary Mitral Regurgitation
- Randomised controlled trial
- non-inferiority
- conducted in Germany
Authors' conclusion
Among patients with heart failure and secondary mitral regurgitation, transcatheter edge-to-edge repair was noninferior to mitral-valve surgery with respect to a composite of death, rehospitalization for heart failure, stroke, reintervention, or implantation of an assist device in the left ventricle at 1 year.
Study context
- Population
- Patients with HF and secondary mitral regurgitation, symptomatic despite guideline-directed medical therapy
- Participants
- 210 patients
- Comparison
- Transcatheter edge-to-edge repair vs mitral-valve surgery
- Primary endpoint
- Composite of:
- Death
- Hospitalization for HF
- Mitral-valve reintervention
- Assist-device implantation
- Stroke
- Follow-up
- 1 year after the procedure
Primary result
As reported in the abstract
1 year
Estimated mean difference
−6 percentage points
95% CI −17 to 6
P < 0.001 for non-inferiority
Events by treatment group
Intervention vs Surgery
estimated mean difference −6 percentage points (95% CI −17 to 6); P for non-inferiority < 0.001
Safety
| Outcome | Intervention | Surgery | estimated mean difference (percentage points) (95% CI) | P value | |
|---|---|---|---|---|---|
| Primary safety end point: composite of major adverse events · 30 days after the procedure | 14.9% | 54.8% | −40 (−51 to −27) | P < 0.001 | |
| −100−50050Difference, percentage points (linear scale) |
- Primary safety end point: composite of major adverse events: 101 vs 93 patients with available data
Original publication
Transcatheter Repair versus Mitral-Valve Surgery for Secondary Mitral Regurgitation. N Engl J Med. Published 31 August 2024. doi:10.1056/nejmoa2408739
Summarised from the published abstract; every number is checked against it