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Abbott Expands XIENCE V(R) USA Trial to Enroll Patients into Landmark Dual Anti-Platelet Therapy (DAPT) Trial
Date:8/13/2009

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. '/>"/>

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