- Late-breaking data presented at American College of Cardiology
Scientific Sessions (ACC.23) and simultaneously published in The
New England Journal of Medicine demonstrate TriClip was
superior to medical therapy with significant improvements in
quality of life and tricuspid regurgitation (TR)
- Findings show TriClip, an investigational device in the U.S. to
treat a leaky tricuspid valve, demonstrated safety and met the
primary endpoint
ABBOTT
PARK, Ill., March 4,
2023 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced late-breaking data for the TriClip™ transcatheter
edge-to-edge repair (TEER) system, a first-of-its-kind minimally
invasive device designed specifically for tricuspid heart valve
repair. The TRILUMINATE™ Pivotal study evaluates the superiority of
TriClip compared to medical therapy in treating patients with
severe, symptomatic tricuspid regurgitation (TR) who are at
intermediate or greater risk for open-heart surgery.
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.
Key Findings From the TRILUMINATE Pivotal Study
The
trial met its composite primary endpoint demonstrating superiority
of the TriClip system compared to the control group (win ratio
1.48, p=0.02), primarily driven by improvement in quality of life.
Mortality or tricuspid valve surgery and heart failure
hospitalizations did not appear different between the groups at one
year. Other positive findings include:
- Significant reduction in TR grade. Significant reduction in TR
to moderate or less (grade < 2) was achieved in 87% of patients
with the device at 30 days vs. 4.8% in the control group, with TR
reduction sustained and durable at one year.
- Significant improvement in quality of life. 50% of patients who
received the device achieved at least a 15-point improvement in the
Kansas City Cardiomyopathy Questionnaire (KCCQ) score (a
self-assessment of social abilities, symptoms and quality of life)
at one year vs. 26% in the control group.
- A strong safety profile. At 30 days, only 1.7% of patients who
received the device experienced major adverse events, with no
urgent surgery or endocarditis. There were no occurrences of device
embolization or device thrombus.
"These TRILUMINATE Pivotal trial results are promising because
there have historically been very few treatment options for
tricuspid regurgitation, and patients with this condition are often
not eligible for open-heart surgery due to multiple co-morbidities
or other factors," said Paul
Sorajja, M.D., the Roger L. and Lynn C. Headrick Family
Chair of the Valve Science Center for the Minneapolis Heart
Institute Foundation and director of the Center for Valve and
Structural Heart Disease for the Minneapolis Heart Institute at
Abbott Northwestern Hospital. "The trial data and real-world use in
Europe from the bRIGHT
post-approval study show TriClip's ability to safely and
effectively repair the tricuspid valve in patients and improve
their quality of life."
"These TRILUMINATE Pivotal data show TriClip is the first
minimally invasive device therapy for the treatment of tricuspid
regurgitation to provide durable improvements in TR severity and
quality of life that go beyond taking medication to manage
symptoms," said Michael Dale, senior
vice president of Abbott's structural heart business. "When left
unaddressed, TR can be debilitating and life-threatening. By
repairing the damage caused by structural heart disease, TriClip G4
and our latest technological innovations are helping people reclaim
their lives so they can get back to doing what they love."
Abbott will also be presenting at ACC late-breaking five-year
results from its landmark COAPT™ trial of the MitraClip™ TEER
device for functional mitral regurgitation in heart failure.
About the Abbott TRILUMINATE Pivotal Trial
The
TRILUMINATE Pivotal trial is the first randomized, controlled
clinical study to evaluate the safety and effectiveness of
transcatheter repair with the TriClip system compared to medical
therapy in people with severe TR.
The primary endpoint was a composite of all-cause mortality or
tricuspid valve surgery, heart failure hospitalizations, and
quality-of-life improvement measured by the KCCQ score.
For U.S. important safety information on MitraClip,
visit http://abbo.tt/MitraClipG4ISI.
TriClip is approved for use in more than 50 countries, including
in Europe and Canada, and is an investigational device in
the U.S.
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
at www.facebook.com/Abbott and on Twitter
@AbbottNews.
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SOURCE Abbott