Temporal trends and clinical characteristics of drug-coated balloon angioplasty for de novo coronary lesions: a six-year analysis from the ORPKI Registry.

BACKGROUND: Drug-coated balloons (DCBs) are established for in-stent restenosis, whereas their role in de novo coronary lesions continues to evolve. Large-scale data on real-world adoption for native lesions remain limited. METHODS: We analyzed the nationwide National Registry of Invasive Cardiology Procedures (ORPKI), including all percutaneous coronary interventions (PCI) performed in Poland between January 2020 and December 2025. Procedures for in-stent restenosis, chronic total occlusion, and plain balloon angioplasty without drug coating were excluded. The final cohort comprised 504,501 PCI procedures for de novo native coronary lesions, classified as DCB-only, stent-only, or hybrid (DCB plus stent). Temporal trends, clinical and angiographic characteristics, and factors independently associated with a DCB-only strategy were assessed. RESULTS: DCB use increased more than eightfold, from 0.55% of procedures in 2020 to 4.78% in 2025 (P<0.001); DCB-only use rose from 0.37% to 4.12%, and hybrid use from 0.20% to 0.66%. The increase was most pronounced in non-main coronary segments (0.8% to 9.5%). Compared with stent-treated procedures, DCB-only procedures more often involved diabetes, chronic kidney disease, previous myocardial infarction, previous PCI, and previous coronary artery bypass grafting (CABG), and chronic coronary syndromes. In multivariable analysis, non-main segment location, previous PCI, previous CABG, diabetes, chronic kidney disease, and the use of optical coherence tomography, intravascular ultrasound, and fractional flow reserve were independently associated with a DCB strategy. CONCLUSIONS: DCB use for de novo coronary lesions increased markedly between 2020 and 2025, with a preference for non-main, distal, and side-branch segments and for clinically complex patients, often alongside intracoronary imaging or physiological assessment.