Temporal trends and clinical characteristics of drug-coated balloon angioplasty for de dovo coronary lesions: A five-year analysis from the ORPKI Registry

Background Drug-coated balloons (DCB) have emerged as a compelling stent-free alternative in percutaneous coronary intervention (PCI), combining the mechanical benefits of balloon angioplasty with targeted, localized antiproliferative drug delivery. While established for in-stent restenosis, there is growing clinical interest in their application for de-novo coronary lesions. However, large-scale, real-world data regarding DCB-only PCI remains limited. Purpose This study sought to evaluate the five-year temporal trends and clinical characteristics of DCB use in de novo lesions within a contemporary PCI cohort. Methods We analyzed data from the ORPKI Registry, a large-scale national registry of PCI in Poland. A total of 535,989 PCIs entered the registry between January 2020, and December 2024. After exclusion in-stent restenosis, only plain old balloon angioplasty (POBA) and CTO procedures the final analysis included 417,689 PCIs for de-novo lesions. DCB procedures were compared with stent PCI. Results The utilization of DCB for de novo lesions PCI demonstrated a significant upward trend, increasing from 0.5% in 2020 to 2.8% in 2024 (p<0.001) (Figure). Of the 6,231 procedures involving DCB, 5,015 (80.5%) were performed as a definitive treatment, while 1,216 involved a hybrid approach with stenting. Patients treated with DCB-only were more likely to have diabetes, chronic kidney disease, previous myocardial infarction and previous PCI. DCB use was significantly higher in chronic coronary syndrome compared with acute coronary syndromes (ACS), whereas stents were predominantly used in ACS. DCB were frequently employed in smaller vessels, including diagonal and marginal branches, as well as distal segments of main vessels. FFR, IVUS and OCT were more frequently used with DCB compared with stent group (Table). In multivariable analysis diabetes, chronic kidney disease, previous myocardial infarction, previous PCI, previous CABG and IVUS and OCT usage were independently associated with DCB strategy selection. Conclusion The utilization of DCB for de novo coronary lesions has increased more than fivefold over the past five years. Current clinical practice favors DCB use in patients with higher baseline complexity and frequently employing adjunctive physiological assessment and intravascular imaging lesion assessment. Notably, DCB are predominantly utilized in specific anatomical location, with a preference for distal segments and side-branch vessels.