Stone GW, et al. - Authors evaluated the impact of transcatheter mitral-valve repair on the clinical outcomes of patients with heart failure who have mitral regurgitation due to left ventricular dysfunction. Lower rate of hospitalization for heart failure and lower all-cause mortality within 24 months of follow-up resulted from transcatheter mitral-valve repair vs medical therapy alone among patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who were symptomatic even after the use of maximal doses of guideline-directed medical therapy. A prespecified safety threshold was surpassed by the rate of freedom from device-related complications.

Methods

• Patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy were enrolled at 78 sites in the US and Canada.
• Experts randomized patients to transcatheter mitral-valve repair plus medical therapy (device group) or medical therapy alone (control group).
• All hospitalizations for heart failure within 24 months of follow-up was the primary effectiveness end point.
• Freedom from device-related complications at 12 months was the primary safety end point; they compared the rate for this end point with a prespecified objective performance goal of 88%.

Results

• Out of the 614 patients enrolled in the trial, 302 were assigned to the device group and 312 to the control group.
• Compared with 67.9% per patient-year in the control group, the annualized rate of all hospitalizations for heart failure within 24 months was 35.8% per patient-year in the device group (hazard ratio, 0.53; 95% confidence interval [CI], 0.40 to 0.70; P < 0.001).
• At 12 months, the rate of freedom from device-related complications was 96.6% (lower 95% confidence limit, 94.8%; P < 0.001 for comparison with the performance goal).
• In the device group, death from any cause within 24 months occurred in 29.1% of patients vs 46.1% in the control group (hazard ratio, 0.62; 95% CI, 0.46 to 0.82; P< 0.001).