TCT-355 Mid-term Outcomes Following Drug Coated Balloon angioplasty for Chronic Total Occlusion. The PICCOLETO X study
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Authors
Cortese B.
Gasparini G.
Calamita G.
Gitto M.
GomezMenchero A.
Torralba E.I.
Basavarajaiah S.
Khedr M.
Smith E.
Minha S.
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2025
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Article
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Abstract
Background: Despite an increasing usage of drug-coated balloons (DCB) for chronic total occlusions (CTO), the clinical performance of this strategy has not yet been investigated adequately, and studies encompass small populations of patients. This study evaluates the procedural characteristics and mid-term clinical outcomes associated with DCB +/- stenting for CTO in a large, multicenter cohort. Method(s): We retrospectively analyzed data from 879 patients with CTO lesions (de novo and in-stent restenosis) treated with either DCB alone or in combination with drug-eluting stent (DES) across multiple high-volume centers. Primary and secondary outcomes were assessed at 6 and 12 months, including target lesion failure (TLF), all-cause and cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and target vessel thrombosis. Result(s): The mean age was 64.4 +/- 10.9 years, and 77.2% of patients were male. De novo CTO constituted 75.8% of lesions, while 24.2% were in-stent restenosis. The patients with single vessel disease were 470 (57.7%), whereas 144 (17.7%) patients had triple vessel disease. 412 (51.2%) patients had calcifications at the CTO site, and 552 (70.4%) had lesion length >=20 mm. Procedural success with final TIMI 3 flow was achieved in 97.6% of cases. At 12-month follow-up, the overall TLF rate was 12.3%, with TLR occurring in 9.3% and cardiac death in 1.4% of the cohort. Of the total cohort, 51.1% patients received DCB-only treatment, while 48.9% received DCB + DES. Comparison between DCB-only and DCB+DES groups showed no statistically significant difference in TLF (11.9% vs. 12.3%, p=0.928) or TVR (7.9% vs. 11.5%, p=0.281). Conclusion(s): In this large, real-world registry, DCB-based treatment of CTO, either alone or combined with DES, was associated with favorable mid-term outcomes and low adverse event rates. These findings support the feasibility of DCB application during CTO interventions and underscore the need for further prospective trials to confirm long-term benefits. [Formula presented] Copyright © 2025
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Journal of the American College of Cardiology
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Transcatheter Cardiovascular Therapeutics Abstracts.