SAN DIEGO, Sept. 23, 2018 /PRNewswire/ -- Abbott (NYSE:
ABT) today announced positive clinical study results from a
randomized controlled trial comparing treatment with the
MitraClip® device to guideline-directed medical therapy
in select patients with secondary (or functional) mitral
regurgitation, or a leaky heart valve, as a result of advanced
heart failure. The landmark COAPT study met both the primary
safety and efficacy endpoints and all secondary
endpoints, and showed treatment with MitraClip plus medical therapy
was superior to medical therapy alone in reducing rates of heart
failure hospitalizations and improving survival at two years. This
therapeutic mitral valve intervention is the first and only to
demonstrate positive outcomes in a clinical trial for ailing heart
failure patients with clinically significant secondary mitral
regurgitation.
The data were presented during a late-breaking session at the
30th Transcatheter Cardiovascular Therapeutics (TCT) annual
scientific symposium of the Cardiovascular Research Foundation in
San Diego, and were simultaneously
published in The New England Journal of Medicine. The COAPT
study data will be submitted to the U.S. Food and Drug
Administration (FDA) to support consideration of an expanded
indication for Abbott's MitraClip to treat secondary mitral
regurgitation.
"These highly anticipated results from the COAPT trial are quite
remarkable, and conclusively demonstrate that heart failure
patients with clinically significant secondary mitral regurgitation
who remain symptomatic despite best medical practices benefit from
treatment with MitraClip," said Gregg W.
Stone, M.D., co-principal investigator of the COAPT study,
director of cardiovascular research and education at
NewYork-Presbyterian/Columbia
University Irving Medical Center and professor of medicine
at Columbia University Vagelos College
of Physicians and Surgeons. "These results have the potential
to transform clinical practice and help patients who otherwise have
an extremely poor prognosis – patients who, to date, have had to
rely only on medications to manage their symptoms without treating
the underlying cause."
MitraClip repairs the mitral valve without the need for an
invasive surgical procedure and is delivered to the heart through
the femoral vein, a blood vessel in the leg. The device works by
clipping together a portion of the leaflets of the mitral valve to
reduce the backflow of blood, which allows the heart to pump blood
more efficiently, thereby relieving symptoms and improving patient
quality of life. The device was approved by the FDA in 2013
to treat the primary (or degenerative) form of mitral regurgitation
(MR), which is caused by an anatomic defect of one or more of the
structures of the mitral valve, which prevents the valve from
closing properly, and subsequently causes leakage. Approximately
one in 10 adults age 75 and older in the U.S., or four million
Americans, suffer from MR.1,2,3,4
The COAPT trial investigated MitraClip for treating secondary
MR, a type of MR in which the damaged left ventricle of the heart –
often due to a heart attack or other cause of heart failure –
impairs the performance of a normal mitral valve. The COAPT data
add to more than 10 years of evidence on the use of MitraClip for
treating primary MR, and now provide randomized trial evidence
supporting MitraClip as a possible option to treat secondary MR.
It's estimated that two to three times as many patients may benefit
from MitraClip treatment for secondary MR as a result of underlying
heart failure, than those treated now for the primary form of the
disease commonly associated with age.5
People with heart failure may develop secondary MR when the left
chamber of the heart becomes enlarged, preventing the mitral
leaflets from closing.6 Significant secondary MR is
difficult to manage, is associated with a poor
prognosis,7 and can lead to reduced quality of life,
recurrent hospitalizations and decreased survival.8,9
While there are currently no FDA-approved devices for secondary MR,
guideline-directed medical therapy (GDMT) and cardiac
resynchronization therapy (CRT, a heart failure treatment that
keeps the right and left ventricles pumping in sync) may provide
symptomatic relief in some patients.10
Most heart failure patients with clinically significant
secondary MR are treated with medication only and have few
treatment options.11 The COAPT study aimed to
assess the safety and efficacy of MitraClip treatment for heart
failure patients with clinically significant secondary MR who
remained symptomatic despite receiving optimal medical therapy.
Key results from the trial include:
- Treatment with MitraClip plus medical therapy resulted in a
statistically significant reduction in heart failure
hospitalization through two years compared to medical therapy alone
(annualized rate of 67.9 percent per year vs. 35.8 percent per
year; p<0.001).
- MitraClip treatment reduced all-cause mortality through two
years, from 46.1 percent of patients in the control group to 29.1
percent in the device group at two years of follow-up
(p<0.001).
- At one year, freedom from device-related complications was 96.6
percent, exceeding the performance goal for the primary safety
endpoint (p<0.001).
- Patients in the device group experienced significant reduction
in MR severity (at one year, MR < 2+ was present in 94.8 percent
of patients in the device group and in 46.9 percent of patients in
the control group; p<0.001) and NYHA class (at one year, NYHA
class I or II was present in 72.2 percent of patients in the device
group and in 49.6 percent of patients in the control group;
p<0.001).
- 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.
About MitraClip
MitraClip received CE Mark
in Europe in 2008 and was approved by the FDA in
2013 for primary MR prohibitive risk patients (patients not
eligible for open-heart surgery). Delivered through a minimally
invasive catheter, MitraClip secures a portion of the leaflets of
the mitral valve with an implanted clip, allowing the heart to pump
blood more efficiently throughout the body, thereby relieving the
symptoms of severe MR and improving patient quality of life.
Patients with MR are often not eligible for standard-of-care
surgery because of advanced age, frailty, multiple comorbidities or
other complicating factors, and the therapy offers a minimally
invasive alternative. The transcatheter clip-based therapy, now on
a third generation of product innovations, has been used to treat
70,000 people with MR worldwide over the last 10
years.
For more information on MitraClip and the COAPT study, visit:
www.coapttrial.com.
For U.S. Important Safety Information about MitraClip,
visit http://mitraclippossibilities.com/#isi-sec.
MitraClip is currently under investigation to treat clinically
significant secondary mitral regurgitation in the U.S. and not
approved by the FDA for secondary mitral regurgitation. The device
has been approved to treat primary mitral regurgitation in the U.S.
since 2013.
About Abbott
At Abbott, we're committed to helping people live their best
possible life through the power of health. For more than 125 years,
we've brought new products and technologies to the world - in
nutrition, diagnostics, medical devices and branded generic
pharmaceuticals - that create more possibilities for more
people at all stages of life. Today, 99,000 of us are working to
help people live not just longer, but better, in the more than 150
countries we serve.
Connect with us at www.abbott.com, on Facebook
at www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
1 Dziaddzko et al, "Outcome and Undertreatment of
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2 AHA Heart Disease and Stroke Statistics Update,
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3 Yancy CW, Jessup M, Bozkurt B, et al. 2017
ACC/AHA/HFSA focused update of the 2013 ACCF/AHA guideline for the
management of heart failure: a report of the American College of
Cardiology/American Heart Association Task Force on Clinical
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Coll Caridol. 2017;70:776-803.
4 Pecini et al EHJ 2011; Asgar et al, JACC 2015;
Nieminen et al, EHJ 2006; Patel et al, Journal of Cardiac Failure
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Coll Cardiol. 2014;63:185-6.
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fraction. Current Opinion in Cardiology. September 2016 - Volume 31 - Issue 5 - p
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Survival and cardiovascular outcomes of patients with secondary
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Cardiology 2017; 2:1130-39.
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10 Stone GW, Vahanian AS, Adams DH, et al. Clinical
trial design principles and endpoint definitions for transcatheter
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Research Consortium. J Am Coll Cardiol 2015;66:278-307.
11 Goel SS, Bajaj N, Aggarwal B, et al. Prevalence and
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regurgitation and heart failure: comprehensive analysis to
determine the potential role of MitraClip for this unmet need. J Am
Coll Cardiol. 2014;63:185-6.
12 Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC
Focused Update of the 2014 AHA/ACC Guideline for the Management of
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