A Medical Device Daily

Abbott (Abbott Park, Illinois) reported the expansion of the company's Xience V USA post-approval study designed to evaluate the safety and effectiveness of the 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 Xience V USA trial to be eligible to cross over into the 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, MD, divisional VP, 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."

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.

The DAPT concept was developed by a consortium of eight companies (four major stent manufacturers, and four manufacturers of anti-platelet medications) who came together to address an FDA request for this post-market study.