Risk of stent thrombosis in patients with short (3 months) DAPT after primary PCI with a biodegradable polymer sirolimus-eluting stent: BIOFLOW III/3 French Satellite substudy

Abstract

The European Society of Cardiology guidelines advocate a shorter duration of dual antiplatelet therapy (DAPT) versus the standard duration after drug-eluting stent implantation in patients with a high risk of bleeding. The safety of this strategy in terms of thrombotic risk is, however, insufficiently investigated. We will report clinical outcomes associated with a short duration of DAPT (≤ 3 months) in patients undergoing percutaneous coronary intervention (PCI) with the Orsiro biodegradable polymer sirolimus-eluting stent. BIOFLOW III French Satellite is a prospective national registry involving 1000 unselected patients treated with the Orsiro stent, conducted in France between November 2014 and July 2016. Using data from this study, we are conducting a prespecified subgroup analysis of patients treated with a short (≤ 3 months) versus standard (> 6 months) duration of DAPT. Analysis of the study data in patients without long-term oral anticoagulation is ongoing. We will compare the baseline characteristics and clinical outcomes of patients discharged after PCI and considered for a short or standard duration of DAPT. The primary endpoint is the incidence of definite, probable and possible stent thrombosis (defined by the Academic Research Consortium) occurring between the end of DAPT and 6 months after stent implantation. Results will be presented at the meeting. This prospective and observational study will evaluate the prevalence and outcomes associated with a short duration of DAPT in patients undergoing PCI with the Orsiro stent in everyday clinical practice.