SAN FRANCISCO, Sept. 29, 2019 /PRNewswire/ -- Abbott (NYSE:
ABT) today announced new analyses of the landmark
COAPTTM Trial that show the company's
MitraClipTM device is cost effective and is projected to
increase both life-expectancy and quality of life compared to
guideline-directed medical therapy (GDMT) alone in heart failure
patients with secondary mitral regurgitation (MR), or a leaky
mitral heart valve. The cost-effectiveness analysis also showed
additional benefits of MitraClip, including decreased use of health
resources after implantation.
The data were presented during the late-breaking clinical trial
session at the 31st Transcatheter Cardiovascular
Therapeutics (TCT) annual scientific symposium of the
Cardiovascular Research Foundation in San Francisco (September 25 - 29) and simultaneously published
in the journal Circulation.
In addition, a second late-breaking data presentation at TCT
showed that over a longer-term follow-up period within the COAPT
Trial, MitraClip continued to remain safe, with durable MR
reduction, reduced hospitalization rates, and improved survival and
quality of life compared to medical therapy alone.
In tandem, the two late-breaking data sets provide strong
evidence of MitraClip's impact on treating secondary MR.
Significant secondary MR has historically been difficult to manage,
is associated with a poor prognosis,1 and can lead to
reduced quality of life, recurrent hospitalizations and decreased
"With longer-term follow-up we continue to see extended benefits
from treatment with MitraClip in advanced heart failure patients
with severe mitral regurgitation, and are encouraged by the latest
findings demonstrating it is also a cost-effective
treatment," said Gregg W.
Stone, M.D., co-principal investigator of the COAPT Trial,
Director of Academic Affairs for the Mount Sinai Heart Health
System and Professor of Medicine and Population Health Sciences and
Policy at the Icahn School of Medicine at Mount Sinai, New
"The pinnacle for all breakthrough therapies is to enhance
patient longevity and quality of life in a cost-effective manner.
These late-breaking data demonstrate that the MitraClip provides
tremendous health benefits for select heart failure patients at a
cost that is acceptable to the US health care system," said
The Importance of Societal & Economic Value
effectiveness data are often used by many payers and health
authorities around the world when making coverage and reimbursement
The COAPT Trial cost-effectiveness analysis demonstrated:
- Transcatheter mitral valve repair (TMVr) using MitraClip in
patients with significant secondary MR was projected to increase
life-expectancy by 1.13 years and quality-adjusted life-years by
- TMVr using MitraClip in patients with significant secondary MR
yielded an "Incremental Cost-Effectiveness Ratio" (ICER) of
$55,600 per quality-adjusted life
year vs GDMT. (ICER is a commonly used health economic measure
where the lower the ICER score, the more cost-effective the
therapy. An ICER score of $55,600
implies that MitraClip provides a positive health economic value,
with ICER scores lower than $100,000
generally considered as cost-effective therapy.)
The health economic data from the COAPT Trial is the first time
a pre-specified economic analysis was integrated into a pivotal
randomized controlled trial that involved a mitral valve repair
Durable, Long-Term Results of MitraClip for Treating
Previously, data from the COAPT Trial had
demonstrated the benefits of MitraClip for select heart failure
patients with clinically significant secondary MR. Now, new
three-year data provides important insights into the durability of
the therapy over long-term follow-up.
Results show that, compared with guideline directed medical
therapy , TMVR using MitraClip was:
- Safe, provided continued reduction in MR, reduced the rate of
heart failure hospitalizations (35.5% vs. 68.8%, HR [95% UCL] =
0.49 [0.63]; P<0.0001)
- Improved survival (all-cause mortality: 42.8% vs. 56.5%, HR
[95% UCL]=0.64[0.82]; p=0.004) at 36 months
- Provided durable improvements in quality of life at 24 months
compared to medical therapy (average improvement in Kansas City
Cardiomyopathy Questionnaire Score: 7.8 vs. -12.1 points,
The three-year clinical results may further help inform a
coverage review being conducted by the Centers for Medicare &
Medicaid Services' (CMS) for an expanded National Coverage
Determination of the procedure. CMS anticipates issuing a proposed
decision memo in February 2020 and
will issue a final decision in May
"Data from the COAPT Trial has consistently shown that treatment
with MitraClip provides a great benefit for these heart failure
patients," said Michael Dale, vice
president of Abbott's structural heart business. "The strong data
showcasing the societal and economic value of the therapy, combined
with even longer-term durability data, provides additional support
to put MitraClip in the hands of more physicians to improve the
outcomes of their patients."
About the MitraClip System
MitraClip is a small,
clip-based device has proven to repair primary and secondary MR
without the need for open-heart surgery. The device is delivered to
the heart through a small incision in the leg and 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
The MitraClip system has been commercially available in the U.S.
since 2013 and in Europe since 2008. With more than 15
years of clinical experience and more than 80,000 patients treated
worldwide, the MitraClip system is the first transcatheter mitral
valve therapy with proven safety and the only with proven survival
and durable clinical outcomes.
MitraClip was approved in the U.S. in 2013 for primary MR
patients. In March 2019, FDA approved
MitraClip for secondary MR patients based on results from the COAPT
Trial, which investigated MitraClip for treating secondary MR. A
landmark trial, COAPT showed a 47% relative reduction in
hospitalizations and a 38% relative reduction in mortality. Both
primary and secondary MR patients may benefit from MitraClip
therapy based on this expanded indication for MitraClip.
Abbott is the global leader in developing transcatheter mitral
valve technologies as alternatives to open-heart surgery. Building
upon its success with the MitraClip device and many years of mitral
valve experience and clinical evidence, Abbott is also leading the
way in novel, transcatheter devices by investing in the development
and clinical study of new mitral valve replacement technologies.
For more information on MitraClip,
For U.S. Important Safety Information about MitraClip,
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
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1 Dwivedi A, Vainrib A, Saric M. Functional
mitral regurgitation in patients with heart failure and depressed
ejection fraction. Current Opinion in Cardiology. September
2016 - Volume 31 - Issue 5 - p 483–492.
2 Sannino A, Smith II RL, Schiattarrella GG, et al.
Survival and cardiovascular outcomes of patients with secondary
mitral regurgitation: a meta-analysis of 53 studies. JAMA
Cardiology 2017; 2:1130-39.
3 Goliasch G, Bartko PE, Pavo N, et al. Refining
the prognosis impact of functional mitral regurgitation in chronic
heart failure. Eur Heart J 2018;39:39-46.