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Stent Safety Study
of 5,000 Patients Started by Abbott for XIENCE V™ Drug Eluting
Stent
XIENCE V USA Study Will Evaluate
Treatment of
Coronary Artery Disease Patients in Real-World Setting
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July 10, 2008 -- Just one
week after FDA approval of the XIENCE V™ Everolimus Eluting Coronary
Stent System, Abbott (NYSE: ABT) has announced that six hospital
centers already are recruiting and enrolling patients
in the XIENCE V™ USA
post-approval study. Post-marketing studies for stents are
now required
of companies by the FDA, as part of the approval process, in order
to better monitor these devices.
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The XIENCE V USA study will
evaluate the safety and effectiveness of the XIENCE V drug eluting
stent in a real-world clinical setting out to five years.
Jack
Jones, M.D., interventional cardiologist and medical director
of the Stormont-Vail Catheterization Lab in Topeka, Kansas,
was one of the first physicians to enroll a patient into the
study. |
"XIENCE V is an important innovation
that gives patients in the United States access to a next-generation
drug eluting stent that has been shown in clinical trials to improve
patient outcomes," said Dr. Jones. "During the stent procedure,
we found it easy to deliver XIENCE V to the diseased portion of
the vessel. With its combination of clinical efficacy and deliverability,
I believe that XIENCE V will become a key advancement in the treatment
of coronary artery disease."
The XIENCE V USA study is designed to evaluate at least 5,000 coronary
artery disease patients treated with the XIENCE V drug eluting stent
at approximately 250 centers across the United States. The primary
endpoint of XIENCE V USA is a measure of stent thrombosis (formation
of blood clots) every year out to five years, as defined by the Dublin/Academic
Research Consortium (ARC). The ARC definition of late stent thrombosis
was developed to eliminate variability in the definitions across various
drug eluting stent trials.
The co-primary endpoint of the study is the composite rate of cardiac
death and any heart attack (Q-wave or non-Q-wave myocardial infarction)
in patients at one year. Secondary endpoints of the study include patient
compliance with prescribed anti-platelet medication, measures of re-treatment
by stenting or surgery, and device and procedural success.
" Post-approval studies allow physicians to follow the safety and efficacy of new treatments in a more complex patient population than is typically studied in pre-approval clinical trials. XIENCE V USA will provide significant insight about the performance of Abbott's new drug eluting stent in a variety of patients," said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs and chief medical officer, Abbott Vascular. "Our ability to work with our physician partners to begin this post-approval study within days of FDA approval is further evidence of Abbott's commitment to help the interventional cardiology community gain additional insights about the clinical benefits of XIENCE V."
About XIENCE V
XIENCE V is used to treat coronary artery disease by propping open
a narrowed or blocked artery and releasing the drug, everolimus, in
a controlled manner to prevent the artery from becoming blocked again
following a stent procedure. XIENCE V is built upon Abbott's market-leading
bare metal stent, the MULTI-LINK VISION® Coronary Stent System. The VISION platform is designed to facilitate ease of delivery, making it easier for physicians to maneuver the stent and treat the diseased portion of the artery.
Long-term results with XIENCE V in the SPIRIT III pivotal U.S. clinical
trial demonstrated a 45 percent reduction in the risk of major adverse
cardiac events (MACE) compared to the TAXUS® paclitaxel-eluting coronary stent system at two years. XIENCE V demonstrated a 32 percent reduction in target vessel failure (TVF, cardiac events related to the stented vessel) compared to TAXUS at two years. XIENCE V also demonstrated a low rate of stent thrombosis between one and two years, defined as very late stent thrombosis, per Academic Research Consortium (ARC) definition of definite/probable stent thrombosis (0.3 percent for XIENCE V and 1.0 percent for TAXUS). XIENCE V met its primary endpoint in the SPIRIT III clinical trial with a statistically significant 50 percent reduction in in-segment late loss (vessel renarrowing) at eight months compared to TAXUS.
The XIENCE V stent is available on both over-the-wire (OTW) and rapid
exchange (RX) delivery systems. Rapid exchange is the most widely used
type of delivery system because it provides physicians additional flexibility
to work as single operators during stent procedures.
XIENCE V was approved by the U.S. Food and Drug Administration on July
2, 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.
Abbott also supplies a private-label version of XIENCE V to Boston
Scientific called the PROMUS™ Everolimus-Eluting Coronary Stent System. PROMUS is designed and manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies.
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 antiproliferative properties.
Additional information about XIENCE V, including important safety and
effectiveness information, is available online at www.xiencev.com.
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 68,000 people and markets its products
in more than 130 countries
Source: Abbott Vascular with additional reporting
by Burt Cohen of Angioplasty.Org
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