Comparing Stopping Versus Continuing Antiplatelet Medicine After Drug-Coated Balloon Angioplasty in Adults with High Bleeding Risk and Chronic Coronary Syndrome

What this Trial Is About

Researchers are evaluating the clinical outcomes of stopping versus continuing antiplatelet therapy in patients with chronic coronary syndrome who have a high risk of bleeding HBR. The study focuses on patients treated with drug-coated balloon DCB angioplasty and standard dual antiplatelet therapy DAPT for 1 to 3 months, followed by maintenance of a single antiplatelet agent for at least one year. This trial explores whether lifelong antiplatelet therapy is necessary after DCB angioplasty in this population, as current evidence mainly involves patients with drug-eluting stents and acute conditions. Participants will be randomly assigned after one year from their DCB angioplasty procedure and standard DAPT. One group will discontinue antiplatelet therapy at randomization, including those still on DAPT, while the other group will continue lifelong antiplatelet monotherapy, either aspirin or clopidogrel, based on physician choice. The study compares these two approaches to better understand post-treatment management in high bleeding risk patients. During the trial, participants will be closely monitored for major bleeding events and other cardiovascular outcomes over one year following the last patient enrollment. Researchers will assess safety and clinical events such as myocardial infarction, death, and revascularization procedures. The study also includes ongoing evaluation of patient status to ensure adherence and track any complications or benefits from the different antiplatelet strategies.

Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk-2