Study Comparing Tailored Versus Conventional Antiplatelet Treatment After Optimized Drug-Eluting Stent Placement Using Imaging Guidance

What this Trial Is About

Researchers are evaluating the safety of a tailored antiplatelet therapy strategy compared to a conventional approach in patients with coronary artery disease who have received optimized drug-eluting stent DES implantation guided by intravascular imaging techniques such as IVUS or OCT. The study aims to determine if the tailored strategy, which involves a shorter duration of dual antiplatelet therapy DAPT followed by P2Y12 inhibitor alone, leads to fewer bleeding events while maintaining similar protection against ischemic complications. This is a Phase 4, prospective, randomized trial enrolling 3,944 patients. Participants are randomly assigned to one of two groups the conventional arm receiving at least 6 months of DAPT aspirin plus clopidogrel for chronic coronary syndrome or at least 12 months of DAPT aspirin plus ticagrelor or prasugrel for acute coronary syndrome, and the tailored arm receiving a shorter DAPT period 1 month for chronic coronary syndrome or 3 months for acute coronary syndrome followed by P2Y12 inhibitor alone for the remainder of 12 months. The optimized DES implantation is confirmed by intravascular imaging to ensure proper stent placement and expansion. During the study, participants will be followed clinically at multiple time points including 1 or 3, 6, 12, 18, 24, 36, 48, and 50 months after the procedure. Researchers will monitor bleeding events classified by the Bleeding Academic Research Consortium BARC criteria, ischemic adverse events such as death, myocardial infarction, and stent thrombosis, and a composite net clinical outcome. Safety and efficacy data will be analyzed primarily at 12 months post-procedure to assess the benefits and risks of the tailored antiplatelet strategy.

Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent