Treatment with MitraClip provided a substantial improvement in patients' perception of their health status, measured by the KCCQ quality-of-life score, and functional capacity at one year.
MitraClip treatment resulted in a reduction in the composite of death or first heart failure hospitalization by 43.0 percent.
The results were consistent across numerous subgroups, including patients with ischemic and non-ischemic cardiomyopathy – a disease of the heart muscle that weakens the ability of the heart to pump blood to the rest of the body – and those at high and low surgical risk.

"Abbott has led the way in developing minimally invasive solutions for some of the most complex challenges in patients with structural heart disease, and the COAPT study results show that MitraClip has the potential to help many more people with heart failure live better and longer, impacting both quality of life and survival," said Neil Moat, M.D., chief medical officer of Abbott's structural heart business. "While MitraClip is already the gold standard for repairing leaky heart valves in patients with primary mitral valve disease who are not surgical candidates, we now have very robust clinical evidence that MitraClip is a life-changing technology for people whose heart failure has resulted in a leaky mitral valve, providing hope to these very sick heart failure patients and their caregivers."

About the COAPT Study
In the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) study, 614 symptomatic heart failure patients with moderate-to-severe or severe secondary MR were randomized to receive treatment with MitraClip plus guideline-directed medical therapy or guideline-directed medical therapy alone at 78 sites in the U.S. and Canada. Eligible patients had diseased heart muscle, known as dilated cardiomyopathy that reduced the amount of blood pumped from the left ventricle; and moderate-to-severe or severe MR assessed by the American Society of Echocardiography guidelines that remained symptomatic despite maximally-tolerated medical therapy and cardiac resynchronization therapy (if appropriate).9,12 Mean patient age was 72.2 years, and 64.0 percent were male. The primary efficacy endpoint was all heart failure hospitalizations through two years, and the primary safety endpoint was freedom from device-related complications at one year compared to a performance goal of 88.0 percent. Secondary endpoints included all-cause mortality at two years, change in quality-of-life at one year, change in functional capacity (six minute walk distance) at one year, MR severity at one year and left ventricle size at one year.

Cardiology Homepage