Abbott Vascular Expands XIENCE V USA Trial to Enroll Patients in Industry-Wide DAPT Trial

August 13, 2009—Abbott Vascular (Santa Clara, CA) announced the expansion of its XIENCE V USA postapproval 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 5 years. The trial expansion allows for an additional 3,000 patients to be enrolled in 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 5 years, as defined by the Dublin/Academic Research Consortium. James Hermiller, MD, and Mitch Krucoff, MD, are the trial's principal investigators.

The expansion also allows for more than 2,000 patients from the XIENCE V USA trial to be eligible to cross over into the landmark Dual-Antiplatelet Therapy (DAPT) trial, an industry-wide collaboration with medical device and pharmaceutical companies. The DAPT trial is an independent, large-scale study in size (more than 20,000 patients) and scope, intended to determine the appropriate duration for dual-antiplatelet therapy, as well as its safety and effectiveness to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events after the implantation of either a drug-eluting or bare-metal stent. A consortium of eight companies (four stent manufacturers and four antiplatelet medications manufacturers) developed the trial to address a US Food and Drug Administration's request for this postmarket study. The Harvard Clinical Research Institute is responsible for the design, conduct, and analysis of the overall study. The DAPT trial will help advance the body of scientific knowledge regarding the best duration for patients to take blood-thinning medications after a stent procedure and establish definitive guidelines, the company stated.

In other company news, on August 24, Abbott Vascular announced that it has received approval from Health Canada for the Xience V everolimus-eluting coronary stent system for the treatment of coronary artery disease. Abbott will launch Xience V in Canada immediately. The device will be available on both over-the-wire and rapid-exchange delivery systems.

Abbott supplies a private-labeled Xience V to Boston Scientific Corporation (Natick, MA) called the Promus everolimus-eluting coronary stent system. Promus is manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies. Xience V and Promus are indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (² 28 mm) with reference vessel diameters of 2.5 to 4.25 mm, the company stated.