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Abbott Begins Post-Approval Study of XIENCE V(TM) Drug Eluting Stent
ABBOTT PARK, Ill.
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"XIENCE V is an important innovation that gives patients in
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 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
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(R) 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(R) 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
Abbott also supplies a private-label version of XIENCE V to Boston Scientific called the PROMUS(TM) 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 http://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
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 more than 68,000 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 http://www.abbott.com.
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