SAN FRANCISCO, Oct. 12, 2015 /PRNewswire/ -- Abbott (NYSE:
ABT) announced today positive one-year clinical results from
the ABSORB III trial, which compared the safety and effectiveness
of Abbott's fully dissolving Absorb™ heart stent to XIENCE
®, Abbott's market-leading, metallic drug eluting stent.
The trial was conducted at 193 sites, primarily in the United States, and enrolled about 2,000
people with coronary artery disease, the most common type of heart
disease. The results, which showed that ABSORB III met its primary
endpoint and will be used to support regulatory approval of Absorb
in the U.S., were featured today during a late-breaking session at
the 27th Transcatheter Cardiovascular Therapeutics
(TCT), the annual scientific symposium of the Cardiovascular
Research Foundation. In addition, the study results were published
simultaneously in The New England Journal of Medicine.
Absorb is a first-of-its-kind device that functions like a
permanent, metallic stent by opening a blocked artery in the heart,
restoring blood flow and providing relief from symptoms of coronary
artery disease (CAD). However, unlike a metallic stent, which
permanently restricts vessel movement and limits future treatment
options, Absorb is made of a naturally dissolvable material that
leaves behind a restored vessel in a natural state, free of a
permanent implant. An unrestricted vessel with restored vessel
function has the potential to flex, pulse and dilate in response to
various demands on the heart, based on people's lifestyle and
activities, and allows for potential future treatment
options.(2,3)
"The ABSORB III data shows that there are no statistically
significant one-year differences between Absorb and XIENCE, which
is a major accomplishment given XIENCE's strong performance as the
current standard of care," said Dean
Kereiakes, M.D., FACC, FSCAI, medical director of The Christ
Hospital Heart and Vascular Center and the Lindner Research Center
in Cincinnati, professor of
clinical medicine at Ohio State
University, and a principal investigator of ABSORB III.
"Naturally dissolving heart stents are the next revolution in
percutaneous coronary intervention, and Absorb is leading the way
as an innovative option. Absorb does its job and then restores the
vessel to its natural state over time, which cannot be achieved
with a permanent drug eluting stent."
Key findings of ABSORB III, a prospective, randomized,
single-blinded, controlled trial, are as follows:
- A primary endpoint of target lesion failure (TLF) of 7.8
percent for Absorb and 6.1 percent for XIENCE (non-inferiority
p<0.007, no statistically significant difference), demonstrating
that both devices are comparable in treating people with CAD. TLF
is a composite of heart disease-related deaths, heart attacks
attributed to the treated vessel, and repeat procedures within the
treated lesion caused by ischemia (lack of oxygen in the treated
vessel).
- All pre-specified secondary endpoint results were not
statistically different.
- There was no statistically significant difference in the rate
of definite and/or probable stent thrombosis (ST).
At this year's TCT, Abbott also presented positive one-year
results from ABSORB China, a prospective, randomized,
single-blinded, controlled trial that compared Absorb to XIENCE to
support Absorb approval in China.
The trial met its non-inferiority primary endpoint of in-segment
late loss at one year, with Absorb at 0.19±0.38 mm and XIENCE at
0.13 ±0.38 mm (p non-inferiority=0.01). The trial enrolled 480
people at 24 sites throughout mainland China. The results were published
simultaneously in the Journal of the American College of
Cardiology. During TCT Abbott will present additional data from the
Absorb family of trials, which have collectively involved more than
13,000 people.
"Results of the ABSORB III pivotal trial show that Absorb is
comparable to the best-in-class metallic stent. However, because
Absorb leaves nothing behind it may provide significant long-term
benefits, such as a restored vessel in a natural state and renewed
possibilities for people treated with Absorb," said Charles Simonton, M.D., FACC, FSCAI, chief
medical officer and divisional vice president, Medical Affairs,
vascular, Abbott. "At Abbott we will continue to study Absorb in
our robust clinical trials to show the long-term benefits of Absorb
that differentiate it from permanent, metallic stents."
Absorb is available in more than 100 countries worldwide and has
been used to treat more than 125,000 people. Abbott completed
its submission for regulatory approval of Absorb in the United States, and it plans to submit for
regulatory approval in China.
ABSORB III is designed to support regulatory approval of Absorb in
the United States, and ABSORB
China is designed to support regulatory approval of Absorb in
China. Currently, Absorb is an
investigational device in the United
States and China, and it is
not approved for commercial use in these countries.
About the Absorb Bioresorbable Vascular Scaffold
(BVS)
Abbott's BVS delivers everolimus, an anti-proliferative drug
used in Abbott's XIENCE coronary stent systems. Everolimus was
developed by Novartis Pharma AG and is licensed to Abbott by
Novartis for use on its drug eluting vascular devices. Everolimus
has been shown to inhibit in-stent neointimal growth in the
coronary vessels following stent or scaffold implantation.
About Coronary Artery Disease
Heart disease is the leading cause of death for men and women
around the world, and coronary artery disease is the most common
type of heart disease.(4,5) Coronary artery disease occurs when
arteries that supply blood to the heart become narrowed or blocked
due to plaque buildup, leading to chest pain or shortness of breath
and increased risk of heart attack.
About Abbott
At Abbott, we're committed to helping people live their best
possible lives 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, 73,000 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) Based on worldwide device utilization rate. Data on
file at Abbott Vascular as of April
2015.
(2) Absorb completely dissolves except for two pairs of tiny
metallic markers, which help guide placement and remain in the
artery to enable a physician to see where the device was
placed.
(3) Preliminary evidence suggests that natural vessel function
is possible and preserves the vessel for future interventions.
(4) The top 10 causes of death, World Health Organization.
June 2011
Available
at: http://www.who.int/mediacentre/factsheets/fs310/en/index.html
(5) Coronary Artery Disease. National Heart, Lung and Blood
Institute. May 2011
Available
at: http://www.nhlbi.nih.gov/health/health-topics/topics/cad/
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