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Abbott announces late-breaking data from landmark COAPT trial
The Fly

Abbott announces late-breaking data from landmark COAPT trial

Abbott announced late-breaking data for MitraClip, the leading therapy to treat leaky valves in people with mitral regurgitation, 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. 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. Now, after five years of patient follow-up, data from the COAPT trial demonstrated even more substantial benefits for patients, including that MitraClip: Significantly reduced the risk of annualized hospitalizations by nearly half; Reduced the risk of death by almost 30%; Achieved durable MR reduction, with 95% of patients experiencing reduced MR from moderate-to-severe or severe to mild or moderate. 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. Patients in the COAPT trial received the first-generation MitraClip, the world’s first transcatheter edge-to-edge repair device. Since the introduction of MitraClip, there have been advances in the device, with the fourth generation of the technology currently on the market, which can reduce MR further. More than 150,000 patients have been treated with MitraClip globally.

Published first on TheFly

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