Comparing Drug-Coated Balloon and Drug-Eluting Stent Treatments in Adults with Coronary Artery Disease at High Bleeding Risk Undergoing PCI

What this Trial Is About

This research evaluates the use of drug-coated balloons DCB compared to drug-eluting stents DES in patients with stable coronary artery disease CAD or acute coronary syndrome ACS who are at high risk of bleeding. The study aims to test whether using DCB with a shorter dual antiplatelet therapy DAPT regimen is not worse than using DES with a longer DAPT duration. If the DCB strategy is found not inferior, its superiority over DES will be further assessed. Participants will receive either a DCB or a DES during percutaneous coronary intervention PCI. The DCB group uses the SeQuent Please device combined with a tailored antithrombotic regimen based on patient stability and oral anticoagulation use. The DES group involves implantation of various CE-marked drug-eluting stents alongside individualized antithrombotic treatment. Treatment regimens vary between stable patients and those with ACS, with differences in DAPT duration and lifelong therapies. Throughout the study, participants are monitored for major adverse cardiac events MACE and bleeding episodes using the BARC classification over 12 months as the primary outcome. Additional outcomes include mortality, revascularization events, myocardial infarction, stroke, and bleeding tracked up to 36 months. The study uses a randomized, triple-blind design to compare these treatments with ongoing safety and efficacy assessments.

Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI