Abbott Vascular's XIENCE 28 GLOBAL Trial Enrolls First Patient in Europe
February 12, 2018—Abbott Vascular announced the first patient has been enrolled in XIENCE 28 GLOBAL, a clinical trial evaluating whether patients at high risk of bleeding can safely remain on dual antiplatelet therapy (DAPT) for only 28 days after implantation with a Xience everolimus-eluting coronary stent.
Professor Emanuele Barbato, MD, PhD, a cardiologist at OLV-Hospital Aalst in Belgium enrolled the first patient in the study. XIENCE 28 GLOBAL, a prospective, single-arm, multicenter, open-label, nonrandomized study, will enroll approximately 800 patients at 50 sites across Europe and Asia.
The primary endpoint is a composite rate of myocardial infarction, stent thrombosis, death, stroke, or major bleeding between 1 and 6 months.
"While blood-thinning medicines are important to prevent clots after a stent is implanted, we want to limit the duration of these medications for people who are at high risk of bleeding," said Marco Valgimigli, MD, PhD, Associate Professor of Cardiology and Senior Interventional Cardiologist at the Universitätsspital in Bern, Switzerland, and Co-Principal Investigator of the study. "This trial will help determine if high-bleeding-risk patients can safely reduce their duration of blood-thinning medication to as short as 28 days."
In 2017, Abbott Vascular also enrolled the first patient in the XIENCE Short DAPT study to evaluate 3 months of DAPT after implantation with a Xience stent in patients who are at high risk of bleeding.