Abbott's ABSORB Bioresorbable Vascular Scaffold Demonstrates Positive One-Year Safety and Efficacy Results
By Abbott, PRNESaturday, April 2, 2011
Clinical Results from 101 Patients Show Low MACE Rate, No Blood Clots and Low Late Loss
NEW ORLEANS, April 3, 2011 - Abbott (NYSE: ABT) today announced positive one-year results from 101
patients enrolled in the second phase of the ABSORB trial evaluating the
world's first drug eluting Bioresorbable Vascular Scaffold (BVS) for the
treatment of coronary artery disease. These results were presented during the
American College of Cardiology's (ACC) 60th Annual Scientific Session and i2
Summit 2011 in New Orleans.
At one year, Abbott's ABSORB device demonstrated a low 6.9 percent rate
of major adverse cardiac events(1) (MACE) and no reports of blood clots
(thromboses). In an analysis of 56 of the 101 patients, imaging results
showed a late loss of 0.27 mm, which is comparable to past data on drug
eluting stents. Importantly, of the patients' vessels that were assessed for
vasomotor function, nearly all showed signs of vasomotion (constriction or
dilation of the vessel) at one year, indicating that vessel movement was
observed in the arteries of these patients as their vessels were no longer
constrained by the scaffold, which had begun to be metabolized.
"The one-year data in these patients confirm earlier results seen at the
six- and nine-month periods - that the ABSORB device has the potential to
effectively treat coronary artery disease with the possibility of restoring
natural vessel function in a way not possible with permanent metallic
implants," said Patrick W. Serruys, M.D., Ph.D., professor of interventional
cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the
Netherlands. "In addition, the one-year late loss seen with ABSORB is similar
to what has been seen in a historical series of drug eluting stents, which is
an encouraging indication that a bioresorbable scaffold like ABSORB might be
able to offer the performance capabilities of a metallic drug eluting stent
but with the added benefit of eventually dissolving away."
ABSORB is made of polylactide, a proven biocompatible material that is
commonly used in medical implants such as dissolvable sutures. The device is
designed to slowly metabolize and eventually be resorbed by the body after
providing support to the vessel during the healing process. ABSORB received
CE Mark in Europe earlier this year and is not approved or available for sale
in the United States.
Since a permanent metallic implant is not left behind, a patient's vessel
treated with ABSORB may ultimately have the ability to move, flex and pulsate
similar to an untreated vessel. Restoration of these naturally occurring
vessel functions, or vascular restoration therapy (VRT), is one of the
features that makes ABSORB a significant innovation for patients in the
treatment of coronary artery disease. In addition, continuing research will
show whether the need to administer long-term dual anti-platelet therapy to
patients is necessary once the temporary scaffold is metabolized.
"The positive one-year clinical results from the ABSORB trial provide
support for the clinical performance of the device and its potential to
change the way coronary artery disease is treated," said Charles A. Simonton,
M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief
medical officer, Abbott Vascular. "Abbott is committed to continuing to build
the body of clinical evidence supporting this novel therapy, and we are
planning additional clinical trials this year."
About the ABSORB Clinical Trials
The ABSORB trial is the first clinical trial evaluating a drug eluting
BVS for coronary artery disease, and Abbott is the only company with
long-term, four-year clinical data on a complete patient set evaluating the
safety and performance of a drug eluting BVS. The ABSORB trial is a
prospective, non-randomized (open label), two-phase study that enrolled 131
patients from Australia, Belgium, Denmark, France, the Netherlands, New
Zealand, Poland and Switzerland. Key endpoints of the study include
assessments of safety - major adverse cardiac events (MACE) and treated-site
thrombosis rates - at 30 days and at six, nine, 12 and 24 months, with
additional annual clinical follow-up for up to five years, as well as an
assessment of the acute performance of the BVS device, including successful
deployment of the system. Other key endpoints of the study include imaging
assessments by angiography, intravascular ultrasound (IVUS), optical
coherence tomography (OCT), and other state-of-the-art invasive and
non-invasive imaging modalities at six, 12, 18 and 24 months.
Results from the first stage of the ABSORB trial with 30 patients
demonstrated that Abbott's BVS successfully treated coronary artery disease
and was resorbed into the walls of treated arteries after approximately two
years. Patients in this first stage of the ABSORB trial experienced no blood
clots (thromboses) out to four years and no new MACE between six months and
four years (3.4 percent at four years).
The ABSORB EXTEND trial is a single-arm study that will evaluate patients
at up to 100 centers in Europe, Asia Pacific, Canada and Latin America. The
trial will enroll approximately 1,000 patients with more complex coronary
artery disease.
About the ABSORB Bioresorbable Vascular Scaffold
ABSORB is made of polylactide, a proven biocompatible material that is
commonly used in medical implants such as dissolvable sutures. The device is
designed to restore blood flow by opening a clogged vessel and providing
support to the vessel. Once the vessel can remain open without the extra
support, ABSORB is designed to slowly metabolize and eventually be resorbed
by the body. Since a permanent implant is not left behind, a vessel treated
with ABSORB may ultimately have the ability to move, flex and pulsate similar
to an untreated vessel. Restoration of these naturally occurring vessel
functions is one of the features that makes ABSORB a significant innovation
for patients in the treatment of coronary artery disease. ABSORB is currently
under development and is not available for sale in the United States.
Abbott's bioresorbable technology delivers everolimus, an
anti-proliferative drug. Everolimus is 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 treated-site neointimal growth in the
coronary vessels following vascular device implantations, due to its
anti-proliferative properties.
About Abbott Vascular
Abbott Vascular is a global leader in cardiac and vascular care with
market-leading products and an industry-leading pipeline. Abbott Vascular
offers a comprehensive cardiac and vascular devices portfolio, including
products for coronary artery disease, vessel closure, endovascular disease,
and structural heart disease.
About Abbott
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 nearly 90,000 people and markets its products in more than
130 countries.
Abbott's news releases and other information are available on the
company's Web site at www.abbott.com.
(1) MACE is an important composite clinical measure of safety and
efficacy outcomes for patients, defined as cardiac death, heart attack
(myocardial infarction or MI), or retreatment of a lesion (ischemia-driven
target lesion revascularization, or ID-TLR).
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