1-Month Versus 6-Month Dual Antiplatelet Therapy After Successful Drug-Coated Balloon-Only Percutaneous Coronary Intervention

Criteria the registry did not label

• \[Inclusion Criteria\]
• Age ≥19 years.
• Written informed consent obtained before randomization and before any study-specific procedures. The conditions allowing consent before or after PCI follow the footnote of the Schedule of Assessments.
• Presenting with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS, including unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction), and clinically stable after PCI.
• Has an indication for coronary PCI based on symptoms, objective ischemia, ACS clinical presentation, coronary physiology, or angiographic findings per routine practice.
• All treated lesions were treated with the Pantera Lux DCB only and Successful DCB-only PCI in all treated lesions, with visually estimated residual diameter stenosis ≤30%, TIMI grade 3 flow, and no flow-limiting dissection, persistent ischemia, or unresolved major procedural complications.
• No coronary stent or scaffold was implanted during the index procedure.
• Able and willing to comply with the assigned antiplatelet regimen and scheduled follow-up, and judged by the investigator to be clinically acceptable for both the 1-month and 6-month DAPT strategies using the P2Y12 inhibitor selected by the investigator.
  • \[Exclusion Criteria\]
• Unable or unwilling to provide written informed consent.
• Known contraindication, hypersensitivity, or clinically unacceptable intolerance to aspirin, any P2Y12 inhibitor permitted by the protocol, heparin, paclitaxel, DCB excipients, or iodinated contrast media that cannot be adequately controlled.
• Active major bleeding at the time of randomization, or another condition that precludes DAPT.
• Requires, or is expected to require, oral anticoagulation after randomization; or has a separate clinical indication, independent of study assignment, that necessitates DAPT beyond 1 month or makes it impossible to maintain 6-month DAPT, such that one of the two assigned strategies would be inappropriate.
• Cardiogenic shock, persistent hemodynamic instability, or need for mechanical circulatory support at randomization.
• Bailout or planned coronary stent/scaffold implantation during the index procedure.
• Additional PCI (including DCB-only PCI) or CABG planned within the first 6 months after randomization.
• Coronary stent implantation within 6 months before randomization.
• History of definite or probable stent thrombosis.
• In-stent restenosis or stent thrombosis as the study target lesion.
• Prior coronary artery bypass grafting (CABG).
• Life expectancy \<1 year due to comorbid conditions.
• Currently participating in another interventional study that may interfere with treatment or endpoint ascertainment.
• Pregnant or breastfeeding, or planning pregnancy during the assigned DAPT period.
• Any other condition in which, in the investigator's judgment, study participation is unsafe or reliable follow-up is unlikely.