Covidien Completes Enrollment in the DEFINITIVE AR Study
New Clinical Study Addresses Restenosis Prevention in Patients with Peripheral
MANSFIELD, Mass. -- January 15, 2013
Covidien (NYSE:COV), a leading global provider of healthcare products, today
announced the completion of enrollment in its DEFINITIVE AR (Anti-Restenosis)
study. As the third study in the DEFINITIVE trial series, this randomized
pilot is designed to address the challenge of preventing restenosis
(re-narrowing of a blood vessel following treatment), a common occurrence in
patients with peripheral artery disease (PAD).
According to the American Heart Association, approximately eight million
people in the U.S. suffer from PAD.^1 PAD affects blood vessels throughout the
body. When the vessels become clogged with plaque, blood flow slows or stops.
If left untreated in the legs or feet, for example, this condition can lead to
severe pain when walking, gangrene and even amputation.
The DEFINITIVE AR study is designed to evaluate the effect of treating a
diseased vessel with a combination therapy that begins with directional
atherectomy to remove plaque build-up, followed by the use of a drug-coated
balloon that releases anti-proliferative medication to inhibit restenosis. As
shown in the DEFINITIVE LE study,^2 directional atherectomy is effective in
treating PAD without leaving a permanent implant behind. While the use of
drug-coated balloons to treat PAD has demonstrated reduced vessel narrowing,
there has been limited clinical study of the effectiveness of this treatment
in calcified lesions. Using a directional atherectomy device to remove plaque
build-up beforehand may increase how well drug-coated balloons work by
improving the uniformity of drug delivery and thereby extending the amount of
time the treated vessel stays open and reducing the need for subsequent
“Covidien is committed to building upon the growing body of clinical evidence
for the use of directional atherectomy in the treatment of complex PAD,” said
Mark A. Turco, MD, Chief Medical Officer, Vascular Therapies, Covidien. “We
are eager to see the results of DEFINITIVE AR and to understand if this
combination therapy of debulking followed by anti-restenotic therapy could
lead to improved drug delivery and improved patient outcomes.”
DEFINITIVE AR Study Design
The DEFINITIVE AR study is a multi-center, randomized study being conducted in
Europe. Patients were randomized to one of two treatments: 1) directional
atherectomy using the Covidien SilverHawk™ or TurboHawk™ plaque excision
systems, followed by a drug-coated balloon using Bayer HealthCare’s
Cotavance^® Peripheral Paclitaxel-coated angioplasty catheter with Paccocath^®
Technology, or 2) treatment with the Cotavance angioplasty catheter alone
(without directional atherectomy prior to treatment). Enrollment in the
randomized portion of the trial is complete. There is a third non-randomized
arm in the trial that is still enrolling patients with heavily calcified PAD.
All patients in this arm are being treated with directional atherectomy
followed by the Cotavance angioplasty catheter. Patients in the study will be
followed for one year.
“The ability of a drug-coated balloon to prevent restenosis may be diminished
by the amount and type of plaque build-up in a patient’s vessel,” said Prof.
Gunnar Tepe, MD, Klinikum Rosenheim in Germany, who is co-leading the
DEFINITIVE AR study with Prof. Thomas Zeller, MD, of the
Universitäts-Herzzentrum Freiburg - Bad Krozingen, also in Germany. “Removing
plaque with directional atherectomy prior to treatment with a drug-coated
balloon may enhance durability of outcomes through increased drug penetration
and uptake into smooth muscle cells.”
Prof. Tepe and Prof. Zeller were investigators in an earlier drug-coated
balloon study called THUNDER.^3 This trial, along with other subsequent
studies, found that the use of paclitaxel-coated angioplasty balloons during
percutaneous treatment of femoropopliteal disease is associated with
significant reductions in late lumen loss and target-lesion revascularization.
About the Covidien SilverHawk™ and TurboHawk™ Plaque Excision Systems
The SilverHawk and TurboHawk plaque excision systems are part of Covidien’s
market-leading portfolio of directional atherectomy devices. These minimally
invasive devices are designed to remove plaque that blocks arteries to restore
blood flow. Unlike other available treatments for PAD, which simply compress
the obstruction(s) against the vessel wall, these devices remove the plaque
from the vessel.
Covidien is a leading global healthcare products company that creates
innovative medical solutions for better patient outcomes and delivers value
through clinical leadership and excellence. Covidien manufactures, distributes
and services a diverse range of industry-leading product lines in three
segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2012
revenue of $11.9 billion, Covidien has 43,000 employees worldwide in 70
countries, and its products are sold in over 140 countries. Please visit
www.covidien.com to learn more about our business.
1. Hirsch AT, Criqui MH, Treat-Jacobson D, et al. Peripheral arterial disease
detection, awareness, and treatment in primary care. JAMA:The Journal of the
American Medical Association. Sep 19 2001;286(11):1317-1324.
2. Lawrence Garcia M. DEFINITIVE LE 12 Month Final Results Paper presented at:
VIVA 2012; Las Vegas, Nevada.
3. Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to
inhibit restenosis during angioplasty of the leg. N Engl J Med. Feb 14
Paccocath and Cotavance are trademarks of Bayer Pharma AG.
David T. Young, 508-452-1644
Manager, External Communications
Bruce Farmer, 508-452-4372
Coleman Lannum, CFA, 508-452-4343
Todd Carpenter, 508-452-4363
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