Late-Breaking Data from Landmark COAPT™ Trial Show Long-Term Benefits of Abbott's MitraClip™ Device
Abbott (NYSE: ABT) released promising five-year data from the COAPT trial at the American College of Cardiology Scientific Sessions, confirming the long-term safety and effectiveness of MitraClip for secondary mitral regurgitation (MR) in heart failure patients. The study indicated a near 50% reduction in annual hospitalizations (33% vs. 57%) and a nearly 30% drop in mortality rates (57% vs. 67%) for those treated with MitraClip compared to standard therapy. Furthermore, 95% of participants experienced a significant improvement in MR severity, showcasing MitraClip's critical role in patient care.
- MitraClip significantly reduced annual hospitalizations by nearly 50% (33% per year vs. 57% control).
- The device reduced the risk of death by almost 30% (57% vs. 67% control).
- 95% of patients experienced durable MR reduction from moderate-to-severe to mild or moderate.
- None.
- New five-year data presented at
American College of Cardiology Scientific Sessions (ACC.23) and simultaneously published inThe New England Journal of Medicine reinforce the long-term safety and effectiveness of MitraClip for treating secondary mitral regurgitation (MR) - Results show minimally invasive mitral valve repair in advanced heart failure patients reduces hospitalizations and deaths and provides durable reduction in the severity of MR
- Historically, advanced heart failure patients battling secondary MR (a leaky mitral valve caused by problems affecting other areas of the heart) have been challenging to treat as a result of limited therapy options
The results were presented at the
Five-Year Results From the COAPT Trial
In the COAPT trial, symptomatic heart failure patients with severe secondary MR (a condition in which a leaky valve caused by problems affecting other areas of the heart allows blood to flow back through the mitral valve) 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 (
33% per year vs.57% in the control group) - Reduced the risk of death by almost
30% (57% vs.67% in the control group) - Achieved durable MR reduction, with
95% of patients experiencing reduced MR from moderate-to-severe or severe (grade ≥ 3+ on a four-point scale) to mild or moderate (grade ≤ 2+)
"Secondary mitral regurgitation is difficult to diagnose and manage, and is often associated with a poor prognosis," said
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.
"With nearly two decades of clinical experience in transcatheter mitral repair, Abbott's MitraClip has paved the way for innovation in helping people with mitral regurgitation, providing an alternative to surgery for patients who often need treatment to survive," said
Patients in the COAPT trial received the first-generation MitraClip, the world's first transcatheter edge-to-edge repair (TEER) 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.
For
About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
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SOURCE Abbott
