Bioresorbable Polymer-Coated EES in Patients at High Bleeding Risk Undergoing PCI Followed by 1-Month DAPT

Objective: To evaluate the safety of bioresorbable polymer-coated everolimus-eluting Synergy® stent followed by 1-month dual antiplatelet therapy in patients at high-bleeding risk. Study population: Real world high-bleeding risk (HBR) patients with coronary artery disease (stable as well as acute coronary syndromes) who qualify for percutaneous coronary interventions. Study size: A total of 1023 patients will be enrolled. Study design: Prospective, single-arm, multicentre trial, powered for non-inferiority with respect to objective performance criteria (OPC). Antiplatelet therapy: Dual antiplatelet therapy with aspirin 100 mg od and a P2Y12 inhibitor for a duration of 1 month, after which single antiplatelet therapy with aspirin will be recommended indefinitely. In case of need for oral anticoagulation, patients will receive an oral anticoagulant in addition to a P2Y12 inhibitor without aspirin for 30 days. Primary endpoint: Composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 1-year follow-up.