This investigator-initiated, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) utilizing a P2Y12 inhibitor compared to dual antiplatelet therapy (DAPT) in the chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS) patients undergoing percutaneous coronary intervention (PCI) with the latest generation rapamycin drug-coated balloon (DCB) without stent implantation. The study aims to assess rates of ischemic and bleeding adverse events.
Age ≥ 18 years.
target lesion in vessels with diameter ≥2.0 and ≤4.5 mm (visual estimation).
the total target vessels ≤2 and a total of target lesions ≤2.
Total length of DCB used for target lesions <60 mm.
Stent implantation within 6 months prior to index percutaneous coronary intervention (PCI).
Treatment for in-stent thrombosis (IST) at the time of index PCI or within 6 months prior to it.
Treatment with a bioabsorbable stent at any time prior to index PCI.
Acute myocardial infarction with ST-segment elevation within the past two weeks.
Parallel
Drug-coated balloon
DeviceFireliums rapamycin eluting coronary balloon dilatation catheter is a rapid exchange catheter, it has a patented microcrystalline coating process to ensure rapid drug delivery to the blood vessel wall and achieve a long-lasting sustained release effect, intended for coronary arteries percutaneous transluminal angioplasties. Patients assigned to this arm will be treated with a Drug-Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care.
Single antiplatelet therapy (SAPT)
DrugThe antithrombotic regimen is single antiplatelet (P2Y12 inhibitor）therapy (SAPT). The Investigator will decide whether to use ticagrelor first; if ticagrelor is not the first-line recommended drug, then clopidogrel will be considered. The type of agent and treatment duration will be selected according to the clinical characteristics of the patient.
Dual antiplatelet therapy (DAPT)
DrugThe antithrombotic regimen will follow the standard of care with a dual antiplatelet regimen (DAPT) per local preferences and international guidelines/ARC consensus paper. The type of agent and treatment duration will be selected according to the patient's clinical characteristics.
Rate of Net Adverse Clinical Events (NACE) at 12 months after randomization
Noninferiority of single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) in stable and unstable acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) without stent implantation assessed by the rate of Net Adverse Clinical Events (NACE). NACE is defined as the composite of all-cause mortality, myocardial infarction, stroke, and bleeding events (defined as BARC grade 3 or 5) following successful PCI with DCB without stent implantation at 12 months after randomization.
Rate of Clinically Relevant Bleeding Events (Bleeding Academic Research Consortium [BARC] Scale, Grades 2-5; range 0-5, where higher grades indicate more severe bleeding and worse clinical outcome)
Incidence of clinically relevant bleeding events classified as BARC grades 2, 3, or 5 according to the Bleeding Academic Research Consortium (BARC) bleeding definition (scale range 0-5; higher scores indicate worse outcome) in the chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS) patients treated with single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) with drug-coated balloon (DCB) without stent implantation.
Patient-oriented composite endpoint (PoCE)
Composite of all-cause death, all myocardial infarctions (MIs), or any repeat revascularization.
Device-oriented Composite Endpoint (DoCE)
Composite of cardiac death, target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (CI-TLR)
Click on the lead sponsor to view all of their trials.
Gan Lijun
Lead sponsor
Affiliated Hospital of Jining Medical University
Sponsor institution
