Comprehensive multicenter evaluation of drug-coated balloon angioplasty in de novo and in-stent restenosis lesions

Drug-coated balloon (DCB) angioplasty is currently recommended by the European Society of Cardiology (ESC) as a Class I, Level A-therapy for the treatment of in-stent restenosis (ISR). Its role in de novo coronary lesions remains under investigation, particularly in real-world clinical practice. Despite their expanding use, multi-center data evaluating both procedural and clinical outcomes are still limited.

To assess procedural success and six-month clinical outcomes of DCB angioplasty in a real-world, multicenter setting.

This prospective, observational registry included 244 consecutive patients who underwent percutaneous coronary intervention (PCI) with DCB between January 2024 and September 2025 across 3 tertiary, Greek cardiac centers. Clinical, angiographic and procedural data were prospectively collected. Procedural success was defined as achievement of TIMI 3 flow without procedural failure or bailout stenting. Clinical follow-up was performed at 1, 3, and 6 months via structured telephone interviews. Major adverse cardiac events (MACE) were defined as the composite of cardiac death, target lesion failure, target vessel re-vascularization or unplanned re-hospitalization.

The mean age was 67.4 ± 10.8 years and 88.5% were men. Clinical presentation included stable coronary artery disease (≈85%) and acute coronary syndromes (≈15%). DCB angioplasty was performed in de novo lesions (80.8%) and ISR (19.2%). Target vessels included LAD (50.3%), RCA (18.5%), and LCx (13.9%). DCB diameters were mainly 2.5 mm (36.8%), 2.0 mm (29%) and 3.0 mm (25%), while lengths were predominantly 15 mm (42.4%) and 25 mm (26.3%). A hybrid DCB–DES approach was used in 51.4%, while DCB-only PCI accounted for 48.6%. Procedural success was 96%. At 6-month follow-up (no contact 10%), 7 (3.1%) target lesion failure, 9 (4%) target lesion re-vascularization and 1 cardiac death (0.045%) were recorded. The overall 6-month MACE rate was 7.7%, with 2.7% in de novo lesions and 5% in ISR lesions, respectively.

In this multicenter real-world registry, DCB angioplasty demonstrated high procedural success (96%) and low 6-month MACE (7.7%) across both de novo and ISR lesions. These findings reinforce the safety and efficacy of a DCB-based strategy, supporting its evolving role into contemporary PCI practice, so long as adequate lesion preparation is preceded.