1. Patients with heart failure and severe secondary mitral valve regurgitation randomized to receive transcatheter mitral valve repair had decreased rates of all-cause mortality and hospitalizations after 24 months compared to patients treated with medical therapy alone.
2. For patients undergoing valve repair, the rate of freedom from device-related complications at 12 months was better than the prespecified trial performance goal.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Heart failure due to left ventricular dilation may secondarily lead to mitral valve regurgitation. Such regurgitation can lead to volume overload and multiple medical complications, including shortened survival, if regurgitation becomes severe. Medical therapy and transcatheter based surgical therapy can both be used to treat patients, though which is better for heart failure patients with severe mitral regurgitation is unknown. The Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) randomized trial sought to evaluate hospitalization rates after 24 months for these patients assigned to either medical therapy or transcatheter mitral valve repair, with patients in the valve repair group experiencing fewer heart failure related hospitalizations. Additionally, all-cause mortality was lower in the valve repair group and the safety profile of patients treated with the valve repair device exceeded the trials prespecified measure.
Strengths of this study include its randomized design, multicenter participation, and extensive subgroup analysis. Limitations include inability to completely blind investigators to the study groups and lack of longer-term follow-up, which is presently being conducted.
In-Depth [randomized controlled trial]: This multicenter, randomized controlled trial enrolled patients from 2012 to 2017. Eligible patients had heart failure with a left ventricular ejection fraction between 20 and 50%, grade 3+ or 4+ secondary mitral valve regurgitation and were symptomatic despite maximal medical therapy. Patients were randomized into a control group treated with medical therapy alone (n=312) and a transcatheter mitral valve repair group (n=302). Patients in the repair group had their procedure performed within 14 days of randomization, and all procedures were performed with the MitraClip device. The trial was sponsored by the device manufacturer, Abbott. Device clips were implanted in 293 of 302 patients (95.0%) in the repair group. Median follow-up in the device and control groups were 22.7 and 16.5 months, respectively. The annualized rates of hospitalization due to heart failure in the device group was 35.8% and 67.9% in the control group (hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.40 to 0.70; P<0.001). The number needed to treat to prevent 1 hospitalization for heart failure in 24 months was 3.1. All-cause mortality within 24 months was 29.1% comparted to 46.1% in the device and control groups, respectively (HR, 0.62; 95% CI, 0.46 to 0.82; P<0.001). For patients in the device group, the rate of freedom from device-related complications was 96.6% at 12 months, higher than the prespecified performance goal of 88.0%. Hazard ratios for hospitalization due to heart failure favored patients treated with the device amongst the majority of subgroups analyzed.
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