February 13, 2018 — Abbott announced the first patient has been enrolled in a clinical trial evaluating 28 days of dual antiplatelet therapy (DAPT) in patients at high risk of bleeding after implantation with a Xience everolimus-eluting coronary stent. The first patient was enrolled into the XIENCE 28 GLOBAL DAPT study by Prof. Emanuele Barbato, M.D., Ph.D., a cardiologist at OLV-Hospital Aalst in Belgium.
Patients who receive a stent are generally prescribed blood-thinning medicines to reduce the risk of stent thrombosis. However, blood thinning medicines can increase the risk of bleeding for some patients due to factors such as older age, chronic use of anticoagulant medications, anemia and renal disease,.
"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, M.D., Ph.D., 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 Europe, most patients at high risk of bleeding are currently treated with DAPT for three to six months after receiving a drug-eluting stent, according to EU treatment guidelines.
XIENCE 28 GLOBAL is a prospective, single-arm, multi-center, open label, non-randomized study. The goal of the study is to assess whether one month of treatment with DAPT is non-inferior to at least six months of DAPT in high-bleeding risk patients. The primary endpoint is a composite rate of myocardial infarction, stent thrombosis, death, stroke or major bleeding between one and six months. Approximately 800 patients will be enrolled at 50 sites across Europe and Asia.
For more information: www.xiencestent.com/featured-trials
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