Abbott announced late-breaking data for MitraClip, the leading therapy to treat leaky valves in people with mitral regurgitation (MR), that demonstrate long-term benefits of the device in patients battling heart failure. The five-year results from the landmark COAPT trial show MitraClip is safe and effective and can cut the rate of hospitalizations while improving survival for heart failure patients with severe secondary MR, a condition which has historically been extremely challenging to treat.
Five-Year Results From the COAPT Trial
In the COAPT trial, symptomatic heart failure patients with severe secondary MR were randomized to receive treatment with MitraClip plus guideline-directed medical therapy or guideline-directed medical therapy alone. The primary results of the COAPT trial through two years found MitraClip to be superior to guideline-directed medical therapy in patients with significant secondary MR.
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“Secondary mitral regurgitation is difficult to diagnose and manage, and is often associated with a poor prognosis,” said Gregg W. Stone, M.D., director of academic affairs for the Mount Sinai Health System and professor of medicine (cardiology) and population health science and policy at the Icahn Mount Sinai, who served as co-principal investigator of the COAPT trial. “These five-year COAPT results further confirm that MitraClip is safe and effective at treating secondary MR in advanced heart failure patients, durably reducing hospitalizations and helping patients live longer.”
While primary MR is due to problems with the mitral valve itself, people with heart failure may develop secondary MR when the left chamber of the heart becomes enlarged, preventing the mitral leaflets from closing and allowing blood to flow backwards through the heart. Significant secondary MR can lead to reduced quality of life, recurrent hospitalizations and decreased survival. Prior to MitraClip, most heart failure patients with clinically significant secondary MR were treated with medication only. However, based on the strength of the primary results of the COAPT trial, in 2019 the FDA approved an expanded indication for MitraClip to treat secondary MR.
SOURCE: PR Newswire