What is the clinical evidence from this study?

Study design: Observational. Population: De novo and in-stent restenosis coronary lesions (n=244). Intervention: Drug-coated balloon (DCB) angioplasty. Primary outcome: Major adverse cardiac events (MACE) at 6 months.

What question did this study set out to answer?

The aim is to evaluate procedural success and clinical outcomes of DCB angioplasty in a diverse patient population.

April 1, 2026

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

Key Result

Drug-coated balloon angioplasty demonstrated 96% procedural success and a 7.7% 6-month MACE rate across de novo and in-stent restenosis lesions.

Key Points

The aim is to evaluate procedural success and clinical outcomes of DCB angioplasty in a diverse patient population.
Conducted a prospective, observational registry
Included 244 patients undergoing PCI with DCB
Collected clinical, angiographic, and procedural data
Defined procedural success as TIMI 3 flow without failure or bailout stenting
Performed follow-ups at 1, 3, and 6 months via telephone interviews.
Achieved procedural success of 96%
Recorded a 6-month MACE rate of 7.7%
Documented target lesion failure in 3.1% of patients
Noted a lower MACE of 2.7% in de novo lesions compared to 5% in ISR lesions
Key vessels treated included LAD, RCA, and LCx.

Study Design

Type

Observational (n=244)

Multicenter

Yes

Structured PICO

Population

244 consecutive patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloon (DCB) across 3 tertiary Greek cardiac centers. Mean age 67.4 ± 10.8 years, 88.5% men. Clinical presentation included stable coronary artery disease (≈85%) and acute coronary syndromes (≈15%). Lesions treated were de novo (80.8%) and in-stent restenosis (19.2%).

Intervention

Drug-coated balloon (DCB) angioplasty (hybrid DCB-DES approach in 51.4%, DCB-only PCI in 48.6%)

Outcome

Procedural success (achievement of TIMI 3 flow without procedural failure or bailout stenting) and 6-month Major adverse cardiac events (MACE: composite of cardiac death, target lesion failure, target vessel re-vascularization or unplanned re-hospitalization)composite

In a real-world multicenter registry, drug-coated balloon angioplasty demonstrated high procedural success (96%) and low 6-month MACE (7.7%) for both de novo and in-stent restenosis lesions.

Limitations

10% loss to follow-up at 6 months

Abstract

Abstract 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 six-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 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. 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 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. Conclusions 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.

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