Heart failure & cardiomyopathiesRandomised controlled trial
Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation
- Randomised controlled trial
- 30 sites in nine countries
Authors' conclusion
Among patients with heart failure with moderate to severe functional mitral regurgitation who received medical therapy, the addition of transcatheter mitral-valve repair led to a lower rate of first or recurrent hospitalization for heart failure or cardiovascular death and a lower rate of first or recurrent hospitalization for heart failure at 24 months and better health status at 12 months than medical therapy alone.
Study context
- Population
- Patients with HF and moderate to severe functional mitral regurgitation
- Participants
- 505 patients
- Comparison
- Device vs Control
- Devicen = 250
- Controln = 255reference
- Primary endpoint
- Three primary end points: composite of first or recurrent HF hospitalization or CV death (24 months); first or recurrent HF hospitalization (24 months); change in KCCQ-OS score (0–100, higher = better) from baseline to 12 months
- Follow-up
- 24 months; 12 months for KCCQ-OS
Primary result
As reported in the abstract
Device
37.0 events per 100 patient-years
HF hospitalization or CV death · HF hospitalization 26.9 events per 100 patient-years · Kansas City Cardiomyopathy Questionnaire-Overall Summary (KCCQ-OS) mean change 21.6±26.9 points
Control
58.9 events per 100 patient-years
HF hospitalization or CV death · HF hospitalization 46.6 events per 100 patient-years · KCCQ-OS mean change 8.0±24.5 points
Safety
- Device-specific safety events
- 1.6% · 4 of 250
Original publication
Summarised from the published abstract; every number is checked against it