Personalized Dual Antiplatelet Therapy Using a Score-Based Algorithm After Coronary Stent Placement Compared to Standard Treatment

What this Trial Is About

Researchers are investigating the use of aspirin combined with a P2Y12 inhibitor, known as dual antiplatelet therapy DAPT, which is the standard treatment for patients undergoing percutaneous coronary intervention PCI with stent placement. The trial aims to compare a score-based decision-making method for determining DAPT duration against the usual care approach that does not use such risk scores. This study is a randomized, single-blind trial designed to provide direct evidence on whether using risk scores improves patient outcomes. The study will include 2788 patients aged 18 years and older who have undergone PCI with stent implantation. Participants will be randomly assigned to one of two groups an algorithm-guided DAPT duration group where therapy length is decided based on the PRECISE-DAPT score, PCI complexity, and clinical condition, or a standard-of-care group where treatment duration is left to the operators discretion. The algorithm group uses specific treatment plans based on risk scores and clinical presentation, with therapy lasting from 1 month up to 12 months followed by monotherapy. Participants will be monitored over one year to assess various outcomes including death, myocardial infarction, stroke, stent thrombosis, and bleeding events. The main measure is a composite of net adverse clinical events NACE occurring within one year. The study will also track adherence to therapy and other cardiovascular events. Safety and effectiveness will be evaluated to understand if the algorithm-guided approach better balances bleeding and ischemic risks compared to standard care.

Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions