August 13, 2009 – Abbott today announced the expansion of the company's XIENCE V USA post-approval study designed to evaluate the safety and effectiveness of the company's XIENCE V 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 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."
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.
The DAPT Trial is an independent, large-scale study in size (20,000 or more 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 FDA request for this post-market study. The Harvard Clinical Research Institute is responsible for the design, conduct and analysis of the overall study.
For more information: www.xiencev.com, www.abbott.com. www.hcri.harvard.edu