Temporal trends and clinical characteristics of drug-coated balloon angioplasty for de novo coronary lesions: A 6-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 < .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 nonmain coronary segments (0.8%-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, nonmain 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 nonmain, distal, and side-branch segments and for clinically complex patients, often alongside intracoronary imaging or physiological assessment.