- New data from the ARIES trial show for the first time that an
aspirin-free regimen can improve outcomes for people living with
the heart pump by reducing hospitalizations without increasing the
risk of blood clots
- More than 30,000 people worldwide have received Abbott's
life-saving heart pump to overcome advanced heart failure
ABBOTT
PARK, Ill., Nov. 13,
2023 /PRNewswire/ -- Abbott (NYSE: ABT) announced new
late-breaking data that show advanced heart failure patients living
with its HeartMate 3™ heart pump who didn't receive aspirin as
part of their blood-thinning medication regimen experienced fewer
complications from bleeding and were associated with reduced
hospital visits compared to patients who took aspirin daily
following their implant. The data from the ARIES trial is the first
to potentially shift how physicians manage their patients living
with a HeartMate 3 heart pump. ARIES marks the first international,
placebo-controlled, randomized clinical study to assess whether the
absence of aspirin is safe and decreases bleeding in people with
the HeartMate 3 left ventricular assist device (LVAD, or heart
pump).
The data were presented during a late-breaking presentation at
the 2023 American Heart Association's Scientific Sessions in
Philadelphia and simultaneously
published in The Journal of the American Medical
Association.
Heart Pump Patients See Benefit in Aspirin-Free
Regimen
The ARIES trial studied more than 600 patients and
found that HeartMate 3 patients who didn't receive aspirin but
continued using the standard post-implant vitamin-K antagonist
(VKA) treatment regimen met the primary endpoint by showing
non-inferiority of no aspirin to aspirin. The HeartMate 3 patients
who did not take aspirin spent 47% fewer days in the
hospital due to a nearly 40% decrease in bleeding events
compared to patients who continued to take aspirin daily.
While the HeartMate 3 is associated with 1lower
rates of complications compared to previous generation heart pumps,
bleeding remains a leading cause for rehospitalizations. The ARIES
trial demonstrated a reduction in bleeding events in patients
without aspirin, which could lead to an important change in
management of patients with a HeartMate 3.
"The ARIES study moves the needle forward in improving the
journey of advanced heart failure patients with a marked
improvement in bleeding events, healthcare resource use and
cost-savings by a simple decision to avoid the use of aspirin,"
said Mandeep R. Mehra, M.D.,
executive director of the Center for Advanced Heart Disease and the
William Harvey Distinguished Chair at Brigham and Women's Hospital
in Boston, Mass. "The data is so
compelling that the magnitude of benefit observed in avoiding
aspirin is similar to the impact of introducing a new device to the
market."
Aspirin-Free Regimen Reduces Costs for HeartMate 3
Patients
In addition to finding reductions in bleeding and
hospital visits for bleeding complications, the ARIES trial also
revealed cost-savings for heart failure patients who did not take
aspirin following implant of an Abbott HeartMate 3 pump. One year
after receiving the device, there was a 41% reduction in estimated
costs related to bleeding events. The data also found this same
group had no elevated risk in developing thrombosis (a blood clot
that increases the risk of stroke).
"There is a general consensus within the medical community that
aspirin use should be a mandatory part of the treatment regimen for
heart failure patients living with an LVAD; however, those
assumptions were largely driven by observational data that have
rarely been challenged," said Robert
Kormos, M.D., divisional vice president, global medical
affairs, Abbott's heart failure business. "The ARIES trial
estimates that for every 100 people with the HeartMate 3, not
taking aspirin prevents nearly 15 major bleeding events within
their first year with the device. That equates to many more moments
these patients can spend with their loved ones living a fuller
life."
About the ARIES Trial
The ARIES trial was an
international, randomized study of either aspirin (100mg/day) or
placebo with VKA therapy in advanced heart failure patients with
Abbott's HeartMate 3 LVAD. The study (July
2020 – September 2022) was
conducted across 51 centers and included over 600 patients in
the United States, Canada, the United
Kingdom, France,
Italy, Austria, Czech
Republic, Kazakhstan and
Australia. ARIES met its primary
endpoint which found that for patients with the HeartMate 3, an
aspirin-free medication regimen is non-inferior to an
anti-thrombotic regimen that includes aspirin. The trial is part of
Abbott's continued commitment to investments in heart failure and
clinical science innovation to further improve the lives of people
with advanced heart failure.
"Abbott has focused its investments on ways that we can continue
to improve the outcomes for the thousands of patients a year who
are eligible to receive a heart pump," said Keith Boettiger, vice president, Abbott's heart
failure business. "With the ARIES trial, we've identified an
important new approach to patient management that doctors can
consider to reduce bleeding risk for their patients and make LVAD
therapy more accessible to patients who need this life-saving
device."
Indications and Important Safety Information:
The
HeartMate 3 Left Ventricular Assist System (LVAS) is indicated for
providing short- and long-term mechanical circulatory support
(e.g., as bridge to transplant or myocardial recovery, or
destination therapy) in adult and pediatric patients with advanced
refractory left ventricular heart failure and with an appropriate
body surface area. It is contraindicated for patients who cannot
tolerate, or who are allergic to, anticoagulation therapy.
For additional U.S. important safety information for the Abbott
HeartMate 3, visit: HeartMate 3 LVAD Indications, Safety and
Warnings | Abbott (cardiovascular.abbott).
The ARIES HeartMate 3 clinical study evaluated a new clinical
approach to patient management, which has not been reviewed by the
U.S. Food and Drug Administration (FDA).
Labeling changes related to the study's anticoagulation regimen
have not been approved by the FDA at this time.
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.
1 Mehra M, et al. New England Journal of
Medicine. 2019; 380:1618-1627
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SOURCE Abbott