Drug-Coated Balloon-Based Angioplasty for Chronic Total Occlusions: The PICCOLETO X Study.
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Cortese Bernardo, Gasparini Gabriele, Meunier Ludovic, Gómez-Menchero Antonio, Smith Elliot J, Basavarajaiah Sandeep, Vinhas Hugo, Litovchik Ilya, Cocco Nino, Picard Fabien, Kumar Abhishek, Bressollette Erwan, Bartus Stanislaw, Ungureanu Claudiu, Mantilla Beatriz Vaquerizo, Luna Mauricio Zuñiga, Santos Ignacio Amat, Colangelo Salvatore, Castillo Karen Lorena, Benedetto Daniela, Arioti Manfredi, Calamita Gianmaria, Torralba Elena Izaga, Khedr Mahmoud, Virginie Laurencon, Monayer Antoinette, Amadora Sintra Daniel Faria, Pham Vincent, Hervouet Sandrine, Gurgoglione Filippo Luca, Malakouti Sara, Ullah Irfan, Jones Daniel A
Аннотация
OBJECTIVES: The aim of this study was to evaluate the clinical outcomes of DCB revascularization strategies in a large, real-world CTO patient population at expert centers.
METHODS: PICCOLETO X was a multicenter, ambispective, all-comers registry including consecutive CTO PCI patients treated with at least 1 DCB across 21 international centers. The primary endpoint was target vessel failure at 12 months, defined as a composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization. The procedural data and outcomes of DCB-only vs DCB + stent strategies, applying a propensity score matching model using a 1:1 nearest neighbor algorithm with a caliper width of 0.2 to overcome baseline differences.
RESULTS: A total of 938 patients were included (DCB only, n = 476; DCB + stent, n = 462). The mean age was 64.6 ± 10.9 years. 73.7% were men, and 38.4% had diabetes. Lesion length ≥20 mm was present in 69%, and 51% of patients had calcified CTOs. As for the in-hospital outcome, acute kidney injury occurred in 3.6% of patients, perforations in 5%, and periprocedural myocardial infarction in 1.8%, with no differences among strategies. At 12 months, target vessel failure occurred in 9.5% of the patient population, with no differences both in the overall cohort (10.6% in the DCB-only group vs 8.4% in the blended group; P < 0.399) and after propensity score matching (6.2% in the DCB-only arm vs 8.8% in the blended arm; P < 0.367) and with no differences for all the determinants of this composite endpoint.
CONCLUSIONS: In a real-world cohort of patients undergoing CTO PCI, a DCB-based strategy, either alone or in combination with stents, was associated with favorable 1-year clinical outcomes. No significant differences were observed between DCB-only and blended treatment with a stent.