Clinical Outcomes of Drug-Eluting Balloon Use in High Bleeding Risk Patients Undergoing PCI: A Retrospective Comparison with Short-DAPT DES
https://doi.org/10.5281/zenodo.17920950
Keywords:
Drug-Eluting Balloon; Drug-Eluting Stent; Percutaneous Coronary Intervention; High Bleeding Risk; Dual Antiplatelet Therapy; Major Bleeding; Net Adverse Clinical EventsAbstract
Background: High bleeding risk (HBR) complicates device selection and dual antiplatelet therapy (DAPT) duration after percutaneous coronary intervention (PCI). Drug-eluting balloons (DEB) may permit shorter DAPT by avoiding permanent metallic scaffolds.
Objective: To compare net clinical outcomes of a DEB-based strategy versus short-DAPT drug-eluting stents (DES) in HBR patients undergoing PCI.
Methods: This single-centre retrospective cohort included consecutive adults fulfilling Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria who underwent PCI at a tertiary cardiac centre between January 1 and June 30, 2025. Patients were treated either with DEB-only angioplasty or with contemporary DES and an intentionally abbreviated DAPT regimen (planned 1–3 months in both groups). The primary endpoint was net adverse clinical events (NACE), defined as major adverse cardiovascular events (MACE: all-cause death, non-fatal myocardial infarction, target vessel revascularization) plus Bleeding Academic Research Consortium (BARC) type 3–5 bleeding. Outcomes were assessed to a median follow-up of 8.1 months.
Results: Of 380 eligible ARC-HBR patients, 180 (47.4%) received DEB and 200 (52.6%) short-DAPT DES. DAPT duration was shorter in the DEB group, with 83.3% versus 66.0% off DAPT by three months. NACE occurred in 10.0% of DEB patients and 19.0% of DES patients (relative risk [RR] 0.53; 95% confidence interval [CI] 0.31–0.89; p=0.02). BARC 3–5 bleeding was lower with DEB (4.4% vs 11.0%; RR 0.40; 95% CI 0.18–0.88; p=0.02), whereas MACE alone was numerically but not significantly reduced (7.8% vs 12.0%; p=0.18).
Conclusion: In HBR patients managed with intentionally abbreviated DAPT, a DEB-based PCI strategy was associated with fewer net adverse clinical events than short-DAPT DES, driven by lower major bleeding without an apparent ischaemic penalty. These real-world data may help guide device choice in this vulnerable population.
