Comparing Single and Dual Antiplatelet Therapy in Patients with Chronic and Stable Acute Coronary Syndrome Undergoing Drug-Coated Balloon-Only Percutaneous Intervention

What this Trial Is About

Researchers are evaluating the safety and effectiveness of single antiplatelet therapy SAPT using a P2Y12 inhibitor compared to dual antiplatelet therapy DAPT in patients with chronic coronary syndrome CCS and stable acute coronary syndrome S-ACS. This trial focuses on patients who undergo percutaneous coronary intervention PCI using the latest rapamycin drug-coated balloon DCB without stent implantation. The study aims to compare rates of ischemic and bleeding events between these two antiplatelet approaches. Participants will receive PCI treatment with a Fireliums coronary rapamycin drug-coated balloon in vessels sized between 2.0 and 4.5 mm. After successful PCI, patients will be randomly assigned to receive either single antiplatelet therapy with a P2Y12 inhibitor such as ticagrelor or clopidogrel or routine dual antiplatelet therapy as per local guidelines. Treatment choice and duration will be personalized based on clinical characteristics. The study is open-label and multicenter. During the trial, participants will be monitored for 24 months after randomization with assessments at 1, 3, 6, 12, and 24 months. Researchers will measure adverse clinical events including net adverse clinical events NACE, bleeding events graded by the Bleeding Academic Research Consortium scale, and composite endpoints focused on patient and device outcomes. Clinical evaluations will include angiography and careful follow-up to track safety and efficacy of the antiplatelet regimens over time.

Single vs. Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Intervention With DCB-only Strategy (KONG-FREEDOM-I)