- New five-year data presented at American College of Cardiology
Scientific Sessions (ACC.23) and simultaneously published in The
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
ABBOTT
PARK, Ill., March 5,
2023 /PRNewswire/ -- Abbott (NYSE: ABT) today
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 (or functional) MR, a condition
which has historically been extremely challenging to treat.
The results were presented at the American College of
Cardiology's 72nd Annual Scientific Session together
with World Congress of Cardiology (ACC.23/WCC) held in New Orleans (March 4-6,
2023). These data were simultaneously published in
The New England Journal of Medicine.
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
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.
"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 Michael Dale, senior
vice president of Abbott's structural heart business. "These
results reinforce that MitraClip plays a critical role in not only
improving the symptoms of people with this serious heart condition,
but also getting them back to living their fullest lives."
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 U.S. important safety information on MitraClip,
visit http://abbo.tt/MitraClipG4ISI.
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.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
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@AbbottNews.
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SOURCE Abbott