- New data presented at Transcatheter Cardiovascular
Therapeutics (TCT) 2023 from the TRILUMINATE™ pivotal trial confirm
safety, effectiveness and improvements in quality of life when
treating tricuspid regurgitation (a leaky valve) with TriClip™, an
investigational device in the U.S.
- One-year outcomes from the EXPAND G4 study, simultaneously
published in JACC: Cardiovascular Interventions,
reinforce durable safety and effectiveness of MitraClip™ with
significant mitral regurgitation reduction
ABBOTT
PARK, Ill., Oct. 24,
2023 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced data from late-breaking presentations showing the impact
of its minimally invasive heart devices in treating mitral and
tricuspid valve disease. Data include findings from the
TRILUMINATE™ pivotal trial that reinforce the safety and
effectiveness of the TriClip™ transcatheter edge-to-edge repair
(TEER) system for patients with symptomatic, severe tricuspid
regurgitation (TR) despite optimal medical therapy.
The company also presented late-breaking data from the
MitraClip™ EXPAND G4 real-world registry that highlights the
device's benefits across a broad group of patients with mitral
regurgitation (MR).
Leaky valves in people with MR and TR can reduce the amount of
blood being pumped through the body and make the heart work harder
than it should. As a result, MR and TR can lead to other
cardiovascular issues as well as severely limit a person's quality
of life. While historically surgery was often necessary to combat
MR and TR, Abbott's minimally invasive portfolio of structural
heart devices has allowed more people around the world to be
effectively treated without the risk of surgical complications.
The following studies using products from Abbott's
industry-leading structural heart portfolio were presented at the
35th Transcatheter Cardiovascular Therapeutics (TCT)
annual scientific symposium of the Cardiovascular Research
Foundation in San Francisco
(October 23-26, 2023).
TriClip: New TRILUMINATE Pivotal Trial Data
The
TRILUMINATE pivotal trial is the world's first randomized,
controlled clinical study evaluating the safety and effectiveness
of transcatheter repair with the TriClip system compared to medical
therapy in people with severe TR. Outcomes to date for all
randomized patients (N=572) and those enrolled in the concurrent
single-arm group (patients with more complex tricuspid valve
anatomy) were presented for the first time at TCT and illustrated
the device's safety, effectiveness and benefits.
Key findings from the TRILUMINATE pivotal trial through one year
include:
- Consistent with and reinforcing the findings in the primary
randomized population (N=350, presented at ACC 2023), TriClip
therapy demonstrated significant improvements in quality of life as
measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
score (a self-assessment of social abilities, symptoms and quality
of life) for the full randomized group, along with an
excellent safety profile.
- The single-arm group with more complex anatomies and advanced
disease met its primary endpoint. The data demonstrated
that TriClip was safe, with 81% of patients achieving TR
reduction to moderate or less and reporting a similar degree of
KCCQ improvement to the randomized population.
"The updated TRILUMINATE pivotal results confirm what has
previously been shown – that TriClip is safe and effective for
patients with severe tricuspid regurgitation," said
David Adams, M.D., chairman of the
department of cardiovascular surgery at the Icahn School of
Medicine at Mount Sinai and cardiac surgeon-in-chief of the Mount
Sinai Health System, who served as co-primary investigator of the
trial. "With the addition of the single-arm data that include
people with more complex tricuspid anatomies, the takeaway is that
TriClip is reducing TR effectively and patients are subsequently
experiencing improvement in their quality of life."
MitraClip: One-Year Results From the EXPAND G4
Study
The EXPAND G4 study is a prospective,
multi-center, global, real-world study of more than 1,100 patients
that reinforces the safety and effectiveness of the
MitraClip G4 system in people with a broad range of anatomies.
One-year results were simultaneously published in JACC:
Cardiovascular Interventions.
Key findings from the EXPAND G4 study at one year include:
- The highest reported MR reduction in a mitral TEER study
to date, sustained through one year, with MR reduction to mild or
less (≤ grade 1+ on a five-point scale) achieved in 93% of
patients, and trace or less MR achieved in 44% of patients.
- Significant clinical improvements, including 82% of patients
achieving New York Heart Association (NYHA) Functional Class I/II
(meaning they reached a point of slight or no limitation of
physical activity), an improvement from 36% at baseline; and a
19-point improvement in KCCQ score.
- MitraClip showed the lowest rates of all-cause mortality (12%)
and hospitalization for heart failure (17%) in a global, real-world
mitral TEER study.
"These late-breaking data at TCT offer further evidence that our
innovative, minimally-invasive heart devices are having a positive
impact on the lives and well-being of those with structural heart
disease," said Michael Dale,
senior vice president of Abbott's structural heart business. "For
more than two decades, Abbott has continued to evolve and expand
its minimally invasive treatment options for mitral and tricuspid
regurgitation. Our portfolio of technologies to restore health and
improve the quality of life of patients with leaky valves
represents new standards of care and an example of our commitment
to leadership in the treatment of structural heart
disease."
For U.S. important safety information on MitraClip,
visit https://abbo.tt/MitraClipISI.
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