Press Release
The Lancet Publishes Two-Year Results of Abbott's Fully Bioabsorbable Drug Eluting Stent
Data Demonstrate Bioabsorbable Stent Is Absorbed Within Two Years, Leaving
Behind Blood Vessels that Appear to Move and Function Similar to Untreated
Vessels
March 12, 2009
Abbott Park, Illinois (NYSE: ABT)
— A comprehensive analysis published today in The Lancet, one of the
world's leading medical journals, from the ABSORB clinical trial demonstrated
that Abbott's bioabsorbable drug eluting stent, currently in development,
successfully treated coronary artery disease and was absorbed into the walls of
treated arteries within two years. The two-year data also demonstrated that
after the bioabsorbable device was absorbed, the treated blood vessels appeared
to move and function similar to unstented arteries. Preliminary findings from
the 30-patient ABSORB trial were presented in October 2008 at the Transcatheter
Cardiovascular Therapeutics annual meeting in Washington, D.C.
"Abbott's bioabsorbable drug eluting stent leaves behind a vessel that
expands and contracts in a manner similar to a vessel that has never been
stented, which could be an advantage over permanent metal-based stent
implants," said Patrick W. Serruys, M.D., Ph.D., professor of
interventional cardiology at the Thoraxcentre, Erasmus University Hospital,
Rotterdam, the Netherlands; lead author of The Lancet publication; and
co-principal investigator of the first phase of the ABSORB trial. "This
bioabsorbable device has the potential to provide optimal vessel scaffolding
and drug delivery capability over the crucial first several months after a
stenting procedure while avoiding the long-term restrictions of metallic
stents."
The ABSORB trial is the world's first clinical trial evaluating a fully
bioabsorbable drug eluting coronary stent, and advanced imaging methods were
used to assess patient outcomes. As published in The Lancet, the first
phase of the ABSORB trial demonstrated the following key results:
- A zero percent rate of stent thrombosis (blood clot formation) for all
patients out to two years of follow up.
- No new major adverse cardiac events (MACE) between six months and two
years. At two years, the bioabsorbable device demonstrated a MACE rate of 3.6 percent (one patient). MACE is defined as any event
that resulted in re-treatment of the treated artery lesion, heart attack or
cardiac death.
- Bioabsorption of the stent at two years after implantation, as confirmed by
an assessment of the stent struts using optical coherence tomography
(OCT).
- Restoration of vasomotion (ability of the blood vessel to contract and
expand) was observed at two years, with the drug acetylcholine used in nine
patients showing vasodilation in the previously stented area, and the drug
methergin used in seven patients showing vasoconstriction in the previously
stented area.
- Reduction in plaque area in treated arteries, corresponding to an increase
in blood flow between six months and two years, as confirmed by intravascular
ultrasound (IVUS) and virtual histology.
"Abbott's bioabsorbable stent may be a major breakthrough in the
treatment of narrowed coronary arteries. The two-year ABSORB trial results show
that the bioabsorbable device did its job of relieving coronary obstructions
and preventing re-narrowing, and that it did this safely," said John
Ormiston, M.D., medical director at Mercy Hospital in Auckland, New Zealand and
principal investigator in the first phase of the ABSORB trial. "With no
rigid stent remaining, vasomotion — the natural movement of the artery — was
restored, and the artery appeared to behave like a normal artery. Who would
want a permanent device if a temporary one may do the job and then
disappear?"
Abbott is the only company with long-term clinical data evaluating the
safety and performance of a bioabsorbable drug eluting coronary stent out to
two years. Abbott's bioabsorbable everolimus eluting coronary device is made of
polylactic acid, a proven biocompatible material that is commonly used in
medical implants such as dissolvable sutures. As with a metallic stent,
Abbott's bioabsorbable stent is designed to restore blood flow by propping a
clogged vessel open, and to provide support until the blood vessel heals.
Unlike a metallic stent, however, a bioabsorbable device is designed to be
slowly metabolized by the body and completely absorbed over time.
"Abbott has consistently been at the forefront of advances in
interventional cardiology -- from the early days of angioplasty to our
continued success with bare metal stents and the market-leading XIENCE V drug eluting stent. Our bioabsorbable device
is another example of scientific innovation leading to an interventional
breakthrough," said John M. Capek, Ph.D., executive vice president, Medical
Devices, Abbott. "Today's data publication in The Lancet confirms
the promise our bioabsorbable device holds as a vasorestorative therapy for
patients with coronary artery disease."
Abbott will begin enrolling patients in the second phase of its
international ABSORB clinical trial in the first half of 2009.
About the ABSORB Clinical Trial
The ABSORB trial is a prospective, non-randomized (open label), two-phase
study designed to enroll approximately 110 patients in Australia, Belgium,
Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key
endpoints of the study include assessments of safety -- MACE and stent
thrombosis rates -- at 30 days, six, nine and 18 months, and one and two years,
with additional annual clinical follow-up for up to five years, as well as an
assessment of the acute performance of the bioabsorbable drug eluting stent,
including successful deployment of the stent. Other key endpoints of the study
include imaging assessments by angiography, IVUS, OCT, and other
state-of-the-art invasive and non-invasive imaging modalities at six and 18
months, and at one or two years.
About XIENCE V
Abbott's market-leading XIENCE V™ Everolimus
Eluting Coronary Stent System was approved by the U.S. Food and Drug
Administration and launched in July 2008, and was launched in Europe and other
international markets in October 2006. XIENCE V
is an investigational device in Japan and is currently under review by the
Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical
Devices Agency.
Additional information about XIENCE V, including important safety and
effectiveness information, is available online at www.xiencev.com.
Everolimus, developed by Novartis Pharma AG, is a proliferation signal
inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its
drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal
growth in the coronary vessels following stent implantation, due to its
anti-proliferative properties.
About Abbott Vascular
Abbott Vascular, a division of
Abbott, is one of the world's leading vascular care businesses. Abbott Vascular
is uniquely focused on advancing the treatment of vascular disease and
improving patient care by combining the latest medical device innovations with
world-class pharmaceuticals, investing in research and development, and
advancing medicine through training and education. Headquartered in Northern
California, Abbott Vascular offers a comprehensive portfolio of vessel closure,
endovascular and coronary products.
About Abbott
Abbott (NYSE: ABT)
is a global, broad-based health care company devoted to the discovery,
development, manufacture and marketing of pharmaceuticals and medical products,
including nutritionals, devices and diagnostics. The company employs more than
72,000 people and markets its products in more than 130 countries.
Media:
Jonathon Hamilton
Jennie Kim |
(408) 845-3491
(408) 845-1755 |
Financial:
Tina Ventura |
(847) 935-9390 |
