Procedural success and 12-month clinical outcomes of drug-coated balloon angioplasty: results from a multicenter prospective registry
N Tsiamis, A Papanikolaou, F Toulgaridis, I Kachrimanidis, I Tolis, E Lampas, D Afendoulis, N Ktenopoulos, S Patsilinakos, S Tzortzis, G Triantis, E Tsiamis, K Aggeli, K Tsioufis, K ToutouzasAbstract
Background
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.
Purpose
To assess procedural success and 12-month clinical outcomes of DCB angioplasty in a real-world, multicenter setting.
Methods
This prospective, observational registry included 244 consecutive patients who underwent percutaneous coronary intervention (PCI) with DCB between January 2024 and January 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 1,3,6 and 12 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.
Results
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 12-month follow-up (no contact 11,8%), 10 (4%) target lesion failure, 12 (5%) target lesion re-vascularization and 1 cardiac death (0.045%) were recorded. The overall 12-month MACE rate was 9.7%, with 3.7% in de novo lesions and 4.2% in ISR lesions, respectively.
Conclusions
In this multicenter real-world registry, DCB angioplasty demonstrated high procedural success (96%) and 12-month MACE (7.9%) 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.Drug coated balloons PCI: 12 months follow upFor image description, please refer to the figure legend and surrounding text.