Abbott Vascular Initiates XIENCE Short DAPT Clinical Trial
July 25, 2017—Abbott Vascular announced that the first patient has been enrolled in a clinical study evaluating the short-term use of dual antiplatelet therapy (DAPT) after receiving Abbott’s Xience everolimus-eluting coronary stent.
The XIENCE Short DAPT clinical trial is a prospective, multicenter, open label, single-arm, nonrandomized study. It will evaluate whether 3 months of DAPT is noninferior to the current standard of 12 months after implantation with a Xience stent for patients who are at high risk of bleeding. The study will enroll approximately 2,000 patients at 100 sites in the United States and Asia.
The primary endpoint is noninferior rates of myocardial infarction or death in high bleeding-risk patients. Secondary endpoints include evaluation of the extent and severity of bleeding rates, stent thrombosis, stroke, revascularization, myocardial infarction, and death.
In the company’s press release, the study’s Global Principal Investigator Roxana Mehran, MD, commented, “Limiting the duration of blood thinning medicine from 12 months to 3 months is particularly important for people at higher risk of bleeding due to factors such as older age, anemia, and renal disease. The results of this study will help determine if doctors can safely reduce the amount of time that high bleeding-risk patients must take blood thinning medication after receiving a Xience stent to unblock coronary arteries.” Dr. Mehran is Professor of Medicine and Director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Weiner Cardiovascular Institute at Mount Sinai School of Medicine in New York, New York.