Coronary disease & ACSTrial design
Single vs. dual antiplatelet therapy in elderly or high bleeding risk (HBR) patients undergoing percutaneous interventions with drug-coated balloons: design and rationale of PICCOLETO IV-EPIC 38 study
- prospective, international, multicenter, investigator-driven, open-label, randomized (1:1), superiority clinical trial
- design and rationale (no results)
- randomization after successful intervention
- primary analysis intention-to-treat; secondary analysis as-treated
Study context
- Population
- Elderly patients aged 75 years or older or HBR patients (Academic Research Consortium criteria) undergoing successful drug-coated balloons (DCB)-only percutaneous coronary intervention (PCI) for native coronary artery disease in vessels with a diameter between 2.0 and 4.0 mm, with chronic or acute coronary syndromesplanned enrolment
- Participants
- 576 patients
- Planned comparison
- Single antiplatelet therapy (SAPT) vs dual antiplatelet therapy (DAPT) after DCB-only PCI
- Primary endpoint
- Net Adverse Clinical Events (NACE): composite of major adverse cardiac events (MACE) (total mortality, target vessel revascularization, spontaneous myocardial infarction) and clinically relevant bleeding events (BARC 2, 3, or 5)
- Follow-up
- 12 months
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Single vs. dual antiplatelet therapy in elderly or HBR patients undergoing percutaneous interventions with drug-coated balloons: design and rationale of PICCOLETO IV-EPIC 38 study. Am Heart J. Published 23 September 2026. doi:10.1016/j.ahj.2026.107606
Summarised from the published abstract; every number is checked against it