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

Korábbi kezelés

• 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.
• True bifurcation lesions requiring treatment with two stents (Medina 1,1,1/1,0,1/0,1,1) with a branch vessel diameter≥2.5 mm (visual estimation).
• Indications for long-term oral anticoagulation therapy.

Más betegség

• Acute myocardial infarction with ST-segment elevation within the past two weeks.
• Active bleeding requiring medical intervention (BARC ≥2) at the time of randomization.
• Known allergy or hypersensitivity to aspirin, clopidogrel, ticagrelor, or sirolimus.
• History of asthma induced by salicylates or substances with similar effects (particularly nonsteroidal anti-inflammatory drugs).

Egyéb

• Patients will be ineligible if they meet any of the following criteria:
• Chronic total occlusion of the target lesion (≥3 months).
• Unprotected left main coronary artery.
• Thrombus present in the target lesion (imaging/visual).
• Total length of DCB used in the target lesion ≥60 mm.
• Life expectancy of less than 1 year.
• Currently participating in another trial and has not yet reached the primary endpoint.
• Pregnant or breastfeeding women.
• Inability to understand and follow study-related instructions or to comply with the study protocol.
• Inability to provide written informed consent

• Subjects who successfully underwent percutaneous coronary intervention (PCI) with drug-coated balloon (DCB) treatment without stent implantation are eligible for inclusion in this study if Male and female patients who meet the following criteria：
• 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.
• The subject's indication for PCI is chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS), include Silent Ischemia, stable angina (SA), unstable angina (UA), non-ST-segment elevation myocardial (NSTEMI), or ST-segment elevation acute myocardial infarction (STEMI) with onset >2 weeks.
• All lesions were successfully treated with a drug-eluting balloon during routine clinical practice, i.e., post-procedural angiographic visual diameter stenosis <30%.
• At the operator's discretion, no flow-limiting angiographic complications requiring extension of dual antiplatelet therapy (DAPT)have occurred.
• All PCI stages have been completed (if applicable), and no further PCI procedures are planned.
• At the time of the randomization visit (within 24 hours after successful drug-eluting balloon treatment during index PCI), the following criteria mustbe met:
• The subject must have had an uneventful clinical course within 24 hours post-index PCI, i.e., no myocardial infarction,symptomatic restenosis, device-related thrombus formation, stroke, or any revascularization procedure (coronary or non-coronary)requiring extension of dual antiplatelet therapy.