Coronary Artery Disease (CAD)
Conditions
Keywords
Dual Antiplatelet Therapy, Drug-Coated Balloon, Percutaneous Coronary Intervention, Coronary Artery Disease, Short-Term DAPT
Brief summary
This study will compare the clinical outcomes of a 1-month dual antiplatelet therapy (DAPT) strategy with a standard 6-month DAPT strategy in patients undergoing successful drug-coated balloon-only percutaneous coronary intervention (DCB-only PCI). The study will evaluate net adverse clinical events (NACE) at 12 months to assess whether short-term 1-month DAPT is non-inferior to 6-month DAPT. The study is a prospective, randomized, open-label, blinded-endpoint, multicenter trial.
Detailed description
This study evaluates whether a short-term 1-month dual antiplatelet therapy (DAPT) strategy is non-inferior to the standard 6-month DAPT strategy in patients who have undergone successful drug-coated balloon-only percutaneous coronary intervention (DCB-only PCI). Patients aged 19 years or older presenting with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) who achieve successful treatment with drug-coated balloons without any permanent stent or scaffold implantation will be enrolled. Eligible participants will be randomly assigned in a 1:1 ratio to either 1-month DAPT followed by single antiplatelet therapy (SAPT) or standard 6-month DAPT followed by SAPT. The primary endpoint is the time to first net adverse clinical events (NACE) from randomization through 12 months, defined as a composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization, or Bleeding Academic Research Consortium (BARC) type 2-5 bleeding. Secondary outcomes include individual components of NACE, target lesion failure (TLF), total bleeding events according to BARC criteria, and clinical outcomes evaluated at a pre-specified 30-day landmark analysis. Clinical events will be adjudicated by an independent Clinical Events Committee. This is a prospective, multicenter, randomized, open-label, blinded-endpoint (PROBE), parallel-group, non-inferiority study. If clinically indicated, antiplatelet therapy may be modified or adjusted according to the investigator's clinical judgment with proper documentation.
Interventions
DRUG1-Month DAPT
Patients receive dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) for 1 month (30 days) following successful drug-coated balloon-only percutaneous coronary intervention (PCI). Aspirin is discontinued between Days 25 and 35, after which patients transition to single antiplatelet therapy (P2Y12 inhibitor monotherapy) through 12 months.
DRUG6-Month DAPT
Patients receive dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) for 6 months (180 days) following successful drug-coated balloon-only percutaneous coronary intervention (PCI). Aspirin is discontinued between Days 166 and 194, after which patients transition to single antiplatelet therapy (P2Y12 inhibitor monotherapy) through 12 months.
Sponsors
Ulsan University Hospital
KangWon National University Hospital
Korea University Guro Hospital
Hanyang University Seoul Hospital
Kosin University Gospel Hospital
Chonnam National University Hospital
Gyeongsang National University Changwon Hospital
Hallym University Medical Center
Daegu Catholic University Medical Center
Sinchon Severance Hospital, Yonsei University College of Medicine
Ulsan Medical Center
Korea University Ansan Hospital
Pusan National University Yangsan Hospital
Inje University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\[Inclusion Criteria\] 1. Age ≥19 years. 2. 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. 3. 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. 4. Has an indication for coronary PCI based on symptoms, objective ischemia, ACS clinical presentation, coronary physiology, or angiographic findings per routine practice. 5. 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. 6. No coronary stent or scaffold was implanted during the index procedure. 7. 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. \[
Exclusion criteria
\] 1. Unable or unwilling to provide written informed consent. 2. 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. 3. Active major bleeding at the time of randomization, or another condition that precludes DAPT. 4. 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. 5. Cardiogenic shock, persistent hemodynamic instability, or need for mechanical circulatory support at randomization. 6. Bailout or planned coronary stent/scaffold implantation during the index procedure. 7. Additional PCI (including DCB-only PCI) or CABG planned within the first 6 months after randomization. 8. Coronary stent implantation within 6 months before randomization. 9. History of definite or probable stent thrombosis. 10. In-stent restenosis or stent thrombosis as the study target lesion. 11. Prior coronary artery bypass grafting (CABG). 12. Life expectancy \<1 year due to comorbid conditions. 13. Currently participating in another interventional study that may interfere with treatment or endpoint ascertainment. 14. Pregnant or breastfeeding, or planning pregnancy during the assigned DAPT period. 15. Any other condition in which, in the investigator's judgment, study participation is unsafe or reliable follow-up is unlikely.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NACE: at 12 Months | From randomization up to 12 months | NACE is defined as a composite of all-cause death, non-fatal myocardial infarction (MI), clinically driven target vessel revascularization (TVR), or Bleeding Academic Research Consortium (BARC) type 2-5 bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NACE: at 24 Months | From randomization up to 24 months | Composite of all-cause death, non-fatal myocardial infarction (MI), clinically driven target vessel revascularization (TVR), or Bleeding Academic Research Consortium (BARC) type 2-5 bleeding. |
| Individual Components of NACE | Up to 12 months and 24 months | Incidence of all-cause death, cardiac death, non-fatal MI (spontaneous or target-vessel MI), clinically driven TVR, and clinically driven target lesion revascularization (TLR). |
| Target Lesion Failure (TLF) | Up to 12 months and 24 months | Composite of cardiac death, target vessel MI, or clinically driven TLR. |
| BARC Type 2-5 and Type 3-5 Bleeding | Up to 12 months and 24 months | Bleeding events defined according to Bleeding Academic Research Consortium (BARC) criteria. |
| Stroke | Up to 12 months and 24 months | Acute focal or global neurological deficit of vascular cause, classified as ischemic, hemorrhagic, or undetermined stroke. |
| Target Lesion Thrombosis and Acute Vessel Closure | Up to 24 months | Definite or probable thrombotic occlusion or acute vessel closure within the DCB-treated segment adjudicated by DCB ARC criteria. |
| Medication Adherence | 1, 6, 12, and 24 months | Rate of adherence to assigned antiplatelet therapy, temporary interruption, permanent discontinuation, and treatment crossover. |
| Ischemic composite endpoint | 12 months and 24 months after randomization | First occurrence of cardiovascular death, non-fatal myocardial infarction, or ischemic stroke. |
Contacts
CONTACTEun-Seok Shin, Professor
Outcome results
None listed