Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Undergoing PCI Comparing 30-Day DAPT Versus Guideline-Directed Therapy

What this Trial Is About

Researchers are investigating the best antithrombotic treatment for patients who have both coronary artery disease (CAD) and atrial fibrillation (AF) and are undergoing percutaneous coronary intervention (PCI). The study compares two approaches: a short course of dual antiplatelet therapy (DAPT) for 30 days versus the standard guideline-directed therapy involving oral anticoagulation (OAC) and P2Y12 inhibitor with aspirin use limited to up to 30 days. The goal is to find a treatment that reduces bleeding risks without increasing ischemic events such as heart attacks or stent thrombosis. Participants are randomly assigned to one of two groups. One group receives DAPT, consisting of aspirin plus a P2Y12 inhibitor, for 30 days after PCI, then switches to edoxaban (an oral anticoagulant) combined with a P2Y12 inhibitor. The other group follows standard therapy with edoxaban and a P2Y12 inhibitor, with aspirin given only during the hospital stay or up to 30 days for high-risk patients, then continuing edoxaban plus P2Y12 inhibitor. The choice and dosing of the P2Y12 inhibitor depend on the treating physician's assessment of bleeding and ischemic risks. During the study, participants are monitored for bleeding and ischemic events up to 6 weeks after PCI, with further follow-up extending to 6 months. Researchers will assess major or clinically relevant non-major bleeding as the primary safety outcome, and a combined measure of death, heart attack, stroke, systemic embolism, or stent thrombosis as the primary efficacy outcome. Additional evaluations include symptom severity and net clinical benefit at multiple time points. The trial is open-label and conducted at multiple centers, lasting until December 2027.

What is the Optimal Antithrombotic Strategy in Patients With Atrial Fibrillation Undergoing PCI?