ABBOTT PARK, Ill., Aug. 13 Abbott (NYSE: ABT) today announced the expansion of the company's XIENCE V(R) USA post-approval study designed to evaluate the safety and effectiveness of the company's market-leading XIENCE V(R) Everolimus Eluting Coronary Stent System in a real-world clinical setting out to five years. The expansion allows for more than 2,000 patients from the XIENCE V USA trial to be eligible to cross over into the landmark Dual Anti-Platelet Therapy (DAPT) Trial, an industry-wide collaboration with medical device and pharmaceutical companies.
"The expansion of the XIENCE V USA trial will enable Abbott to enroll more than 2,000 patients who may be eligible to also participate in the DAPT Trial to help advance the body of scientific knowledge regarding the best duration for patients to take blood-thinning medications after a stent procedure," said Charles Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. "We anticipate the DAPT Trial results will be instrumental in establishing definitive guidelines. As an industry leader, Abbott is proud to play a significant role in contributing patients to this important study."
The first patient was enrolled into the XIENCE V USA expansion by James Hermiller, M.D., director, Cardiac Catheterization Labs, The Care Group at St. Vincent Hospital in Indianapolis, Ind. Dr. Hermiller is a principal investigator of the XIENCE V USA trial along with Mitch Krucoff, M.D., FACC, FCCP, director, Cardiovascular Devices Unit, Duke Clinical Research Institute in Durham, N.C.
The XIENCE V USA trial expansion allows for an additional 3,000 patients to be enrolled into Abbott's study, which was originally designed to study 5,000 patients in the United States. The primary endpoint of XIENCE V USA is a measure of stent thrombosis 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.
About the DAPT Trial
The DAPT Trial is an independent, large-scale study in size (20,000+ patients) and scope intended to determine the appropriate duration for dual anti-platelet therapy (the combination of aspirin and a second anti-clotting medication to reduce the risk of blood clots) as well as the safety and effectiveness of DAPT to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of either a drug eluting or bare metal stent.
The DAPT concept was developed by a consortium of eight companies (four major stent manufacturers, including Abbott, and four manufacturers of anti-platelet medications) who came together to address a U.S. Food and Drug Administration (FDA) request for this post-market study. The Harvard Clinical Research Institute (www.hcri.harvard.edu) is responsible for the design, conduct and analysis of the overall study.
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.
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.
Abbott's market-leading XIENCE V drug eluting stent is marketed in the United States, Europe and other international markets. XIENCE V is an investigational device in Japan and is currently under review by Japan's Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency. It is also under review with Health Canada.
Abbott also supplies a private-label version of XIENCE V to Boston Scientific called the PROMUS(R) 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.
XIENCE V is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions = 28 mm) with reference vessel diameters of 2.5 mm to 4.25 mm. Additional information about XIENCE V, including important safety information, is available online at www.xiencev.com or www.abbottvascular.com/en_US/content/document/eIFU_XienceV.pdf.
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.
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 72,000 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.