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 everolimus-eluting coronary stent (Xience, Abbott). The first patient was enrolled into the study by Emanuele Barbato (OLV-Hospital Aalst, Aalst, Belgium).
XIENCE 28 GLOBAL is a prospective, single-arm, multicentre, open-label, non-randomised 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.
Marco Valgimigli (Universitätsspital, Bern, Switzerland), co-principal investigator of the study, says: “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. 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.”
“Since the initial approval of Xience more than 10 years ago, real-world data from more than 100 clinical trials gives us confidence in Xience’s safety and helps us better understand and address the needs of patients who are at high risk for bleeding complications. This study is designed to help address challenges of patients who are more likely to experience bleeding complications and therefore cannot tolerate prolonged DAPT,” comments Charles Simonton, chief medical officer of Abbott’s vascular business.
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.