ABBOTT PARK, Ill., March 24 /PRNewswire-FirstCall/ -- Abbott today
announced positive results from ABSORB, the world's first clinical trial
evaluating the overall safety and performance of a fully bioabsorbable
drug- eluting stent platform for the treatment of coronary artery disease.
Six- month results from the first 30 patients in the trial, presented at
the 56th Annual American College of Cardiology Scientific Session in New
Orleans, demonstrated no stent thrombosis and a low (3.3 percent)
hierarchical rate of ischemia-driven Major Adverse Cardiac Events (MACE),
such as heart attack or repeat intervention.
"The encouraging results from the first 30 patients of ABSORB suggest
that drug-eluting bioabsorbable stent technologies may be a promising
future therapy option for physicians treating patients with heart disease,"
said Patrick W. Serruys, M.D., Ph.D., professor of interventional
cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, who
is co-principal investigator of the study. "A drug eluting stent that would
eventually disappear after restoring blood flow is an exciting concept that
we look forward to further exploring."
The single MACE event reported was a non-Q-wave myocardial infarction.
The same patient underwent a repeat intervention that occurred at the site
of the original procedure, resulting in an overall target lesion
revascularization rate of 3.3 percent. The trial results confirmed that the
treatment effect of everolimus in the bioabsorbable stent is similar to
that observed in Abbott's studies of metallic drug-eluting stents, with
everolimus actively inhibiting tissue growth into the artery. The rate of
device success (successful placement of the bioabsorbable stent at the site
of the lesion) was 93.5 percent.
Abbott's everolimus-eluting bioabsorbable stent 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, the
bioabsorbable stent is designed to restore blood flow by propping the
vessel open, providing support until the blood vessel heals. Unlike a
metallic stent, a bioabsorbable stent is designed to be slowly metabolized
by the body and completely absorbed over time.
"Based on these encouraging safety results, Abbott will continue to
advance this technology by enrolling the next cohort of patients in the
ABSORB study in Europe and New Zealand," said John M. Capek, Ph.D., senior
vice president, Abbott Vascular. "The next phase of the ABSORB study will
utilize a next-generation bioabsorbable everolimus-eluting stent that
incorporates several advancements designed to improve strength and
About the ABSORB Trial
The ABSORB trial is a prospective, non-randomized (open label) study
designed to enroll up to 60 patients in Belgium, Denmark, France, New
Zealand, Poland and The Netherlands. Key endpoints of the study include
assessments of safety -- MACE and stent thrombosis (blood clot formation)
rates -- at 30, 180 and 270 days, with an annual follow-up for up to five
years, and successful deployment of the bioabsorbable drug-eluting stent.
Other key endpoints of the study include follow-up measurements assessed by
angiography, IVUS, and state- of-the-art imaging modalities at 180 days and
two years, as well as a new noninvasive technique in a subset of patients
at 18 months. The co-principal investigator of the study is John Ormiston,
M.D., of Mercy Hospital in Auckland, New Zealand.
For images of Abbott's bioabsorbable stent and other information,
please visit the company's online ACC newsroom at
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 that are recognized internationally for their safety
and effectiveness in treating patients with vascular disease.
Abbott 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 65,000 people and markets its products in more than 130
Abbott's news releases and other information are available on the
company's Web site at http://www.abbott.com .