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Minerva Cardiology and Angiology 2023 Sep 13

DOI: 10.23736/S2724-5683.23.06352-4


lingua: Inglese

Procedural and one-year outcomes following drug-eluting stent and drug-coated balloon combination for the treatment of de novo diffuse coronary artery disease: the HYPER Study

Andrea BUONO 1, Mariano PELLICANO 2, Damiano REGAZZOLI 3, Michael DONAHUE 4, Delio TEDESCHI 5, Marco LOFFI 6, Giuseppe ZIMBARDO 4, Bernhard REIMERS 3, Giambattista DANZI 6, Giuseppe DE BLASIO 2, Maurizio TESPILI 2, Alfonso IELASI 2

1 Unit of Interventional Cardiology, Cardiovascular Department, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy; 2 Division of Cardiology, Galeazzi Sant’Ambrogio IRCCS Hospital, Gruppo Ospedaliero San Donato, Milan, Italy; 3 Humanitas Research Hospital IRCCS, Rozzano, Milan, Italy; 4 Department of Cardiology, Policlinico Casilino, Rome, Italy; 5 Interventional Cardiology, Sant’Anna Clinical Institute, Brescia, Italy; 6 Operative Unit of Cardiology, Territorial Social Health Authority of Cremona, Cremona, Italy


BACKGROUND: De novo diffuse coronary artery disease (CAD) is a challenging scenario in interventional cardiology with limited treatment option, beside stent implantation. In this context, a hybrid approach, combining the use of drug-eluting stent (DES) and drug-coated balloon (DCB) to treat different segments of the same lesion (e.g. long lesion and/or true bifurcation), might be an interesting and alternative strategy to limit the metal amount. The aim of this study was to evaluate the safety and efficacy of a hybrid approach in addressing percutaneous treatment of de novo diffuse CAD.
METHODS: This was a prospective, multicenter study including patients affected by de novo diffuse CAD treated with a hybrid approach from April 2019 to December 2020. Angiographic and clinical data were collected. The primary endpoint was the one-year device-oriented composite endpoint (DOCE, cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization [ID-TLR]). Periprocedural myocardial infarctions and periprocedural success were included among secondary endpoints.
RESULTS: One hundred six patients were included, mean age was 68.2±10.2 years and 78.3% were male. De novo diffuse CAD consisted of 52.8% long lesions and 47.2% true bifurcation lesions. Significant increase in the final minimal lumen diameters and significant decrease in the final diameter stenosis were observed when compared to the baseline values in both DES- and DCB-target segments. Procedural success was 96.2%. DOCE at one-year was 3.7%, with all the adverse events characterized by ID-TLR.
CONCLUSIONS: Combination of DES and DCB could be a safe and effective treatment option for the treatment of de novo diffuse CAD (NCT03939468).

KEY WORDS: Coronary artery disease; Percutaneous coronary intervention; Drug-eluting stents

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