Patients with heart failure who have mitral regurgitation due to left ventricular dysfunction show poor prognosis. As many patients remain symptomatic despite maximal doses of guideline-directed medical therapy, it was evaluated whether transcatheter mitral-valve repair would improve clinical outcomes.
614 patients were enrolled in the multicenter, randomized, controlled, parallel-group, open-label COAPT trial. 302 were assigned to the device group, receiving valve repair (Abbott’s MitraClip device) and guideline-directed medical therapy. 312 were appointed to the control group receiving medical therapy only.
In the group receiving transcatheter mitral-valve repair, the rate of all hospitalizations for heart failure (the primary effectiveness end point) was 35.8% per patient-year, as compared with 67.9% in the control group (hazard ratio, 0.53; p<0.001). 29.1% of the patients in the device group died from any cause, as compared with 46.1% in the control group (hazard ratio, 0.62; p<0.001). Freedom from device-related complications (the primary safety end point) was 96.6% (p<0.001 as compared with a performance goal).
Therefore, device-based treatment resulted in a significantly lower rate of hospitalization for heart failure and lower mortality, as compared to medical therapy alone. Furthermore, quality of life and functional capacity was improved. Freedom from device-related complications exceeded the pre-specified performance goal.
Author: Frederike Schmitz