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Observational Study
. 2025 Aug;114(8):1059-1070.
doi: 10.1007/s00392-025-02664-x. Epub 2025 May 19.

Validation of complex PCI criteria in drug-coated balloon angioplasty

Francesco Tartaglia  1   2 , Mauro Gitto  1   2 , Pier Pasquale Leone  3 , Mauro Chiarito  1   2 , Gianmaria Calamita  1   2 , Gianluca Mincione  1   2 , Gabriele Gasparini  2 , Bernhard Reimers  2 , Ottavia F Cozzi  1   2 , Marco L Rossi  4 , Giulio G Stefanini  1   2 , Damiano Regazzoli  2 , Antonio Mangieri  2 , Antonio Colombo  5   6   7
Affiliations
Observational Study

Validation of complex PCI criteria in drug-coated balloon angioplasty

Francesco Tartaglia et al. Clin Res Cardiol. 2025 Aug.

Abstract

Background: Procedural complexity during percutaneous coronary interventions (PCI) with drug-eluting stent (DES) has been associated with adverse events, especially in case of long and multiple stents implantation.

Objective: This study aims to validate contemporary complex PCI criteria for drug coated balloon (DCB)-based PCI.

Methods: Consecutive patients undergoing DCB angioplasty at 2 Italian centers from 2018 to 2023 were retrospectively enrolled. Complex DCB-PCI was defined as the presence of at least 1 of the 6 following features: 3 vessels treated; ≥ 3 lesions treated; ≥ 3 devices (DES or DCB) used; bifurcation treated with 2 devices; total device length (DES + DCB) > 60 mm; CTO as target lesion. The primary endpoint was the 2 year incidence of target lesion failure (TLF), a composite of target lesion revascularization (TLR), target vessel-myocardial infarction and cardiac death, at time-to-first event analysis.

Results: A total of 1279 patients were included, of whom 642 (50.2%) met complex PCI criteria. The most frequently met criteria was "total device length > 60 mm" (71.6% in the complex PCI group). The proportion of in-stent restenosis (ISR) was 30.8% in the complex DCB-PCI group and 43.8% in the non-complex PCI group (p < 0.001). After adjusting for relevant clinical covariates and for the presence of ISR, patients undergoing complex PCI had a higher incidence of TLF at 2 years as compared to those undergoing non-complex PCI (16.7 vs. 11.4%; adj. hazard ratio 1.73, 95% confidence interval 1.16-2.59, p = 0.007). However, such difference was significant only in the ISR subgroup, while outcomes of complex and non-complex PCI for de novo lesions were similar.

Conclusions: In a real-world cohort of patients undergoing DCB angioplasty, complex PCI criteria were frequently met and associated with higher risk of TLF. However, their prognostic impact was limited in patients with de novo coronary lesions treated with DCB.

Keywords: Complex; Drug-coated balloon; Percutaneous coronary intervention.

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Conflict of interest statement

Declarations. Conflict of interest: The authors declare no conflicts of interest to disclose.

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