Abbott Vascular Will Initiate Trial of 3-Month DAPT With Xience Family of DES

October 29, 2013—Abbott Vascular (Santa Clara, CA) announced that it will initiate a randomized, controlled trial in the United States to evaluate the use of dual-antiplatelet therapy (DAPT) for a 3-month duration after treatment with the company's Xience family of drug-eluting stents (DES). The trial is designed to support regulatory filings to update the product labeling for Abbott's Xience family of DES in the United States, where DAPT duration is currently recommended for a minimum of 12 months after treatment with a DES.

According to the company, the trial will randomize more than 4,000 patients to either a 3-month or a 12-month DAPT regimen after implantation with a Xience DES. Patients will be blinded to which regimen they are taking. The primary endpoint of the trial will be the difference in the rate of major adverse cerebral and cardiovascular events (MACCE). The primary investigators for the trial are Mitch Krucoff, MD, and Roxana Mehran, MD.

In the Abbott Vascular announcement, Dr. Krucoff commented, “The appropriate duration of DAPT following treatment with a DES is one of the most important and highly debated topics among cardiologists. Prolonged use of DAPT can be associated with issues such as bleeding complications, patient noncompliance, and increased cost, and it is not clear that it is associated with a marked safety benefit. Abbott's leadership in embarking on this clinical trial is an important step in addressing a key question about optimizing therapy with DES.”

Dr. Mehran added, “Patients often struggle with taking blood thinners for a year or more following implantation of their stent. This randomized trial will provide the highest level of clinical evidence to inform physicians about the appropriate duration of DAPT for patients in the United States treated with the Xience family of DES."

Abbott Vascular details that its family of Xience DES includes the Xience Xpedition, the Xience Prime and Xience Prime LL, and the Xience V. The Xience Xpedition is available in the United States, Japan, Europe, the Middle East, and parts of Asia. Xience Prime and Xience V are available in countries throughout the world. In the United States, the Xience Xpedition and Xience Prime stent systems, including Xience Prime LL, are indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm. In the United States, Xience V is indicated for improving coronary luminal diameter in patients with symptomatic heart disease caused by de novo native coronary artery lesions (lesions ≤ 28 mm) with reference vessel diameters of 2.25 mm to 4.25 mm.