Bifurcation percutaneous coronary intervention (PCI) with a hybrid strategy with drug- eluting balloons versus a stepwise provisional two- stent strategy: Rationale and design of the hybrid drug-eluting balloons (DEB) study
Study context
- Population
- Patients with de novo true coronary bifurcation lesions treated with a stepwise provisional approach and an unsatisfactory side-branch result after main vessel stenting (≥ 70% stenosis and/or < TIMI III flow)planned
- Participants
- 500 patients
- Planned comparison
- Hybrid DEB strategy vs stepwise provisional two-stent strategy
- Primary endpoint
- Composite of:
- All-cause death
- Periprocedural or spontaneous MI and/or target vessel revascularization
- Follow-up
- anticipated median 2-year follow-up
Methodological detailsdesign paper, prospective, multicentre, non-inferiority, 1:1 randomisation
- Design paper
- Prospective
- Multicentre
- Non-inferiority
- 1:1 randomisation
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Bifurcation PCI with a hybrid strategy with drug- eluting balloons versus a stepwise provisional two- stent strategy: Rationale and design of the hybrid DEB study. Am Heart J. Published 6 October 2023. doi:10.
Summarised from the published abstract; every number is checked against it