Key result
DCB angioplasty yields a ~10% 12-month MACE rate in real-world coronary interventions.
Why the study?
Although DCB angioplasty is recommended for in-stent restenosis, its role in de novo coronary lesions remains under investigation, and multicenter data evaluating both procedural and clinical outcomes in real-world practice are limited.
Observational (n=244)
Yes
In a multicenter real-world Greek registry, drug-coated balloon angioplasty demonstrated a high procedural success rate (96%) and low 12-month MACE rates across both de novo and in-stent restenosis coronary lesions.
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.
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Tsiamis et al. (2026) conducted an observational in De novo coronary lesions and in-stent restenosis (ISR) (n=244). Drug-coated balloon (DCB) angioplasty was evaluated on Major adverse cardiac events (MACE: composite of cardiac death, target lesion failure, target vessel re-vascularization, or unplanned re-hospitalization) at 12 months and procedural success. Drug-coated balloon angioplasty achieved 96% procedural success and a 9.7% 12-month MACE rate (3.7% in de novo and 4.2% in in-stent restenosis lesions) in a real-world registry.
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