Impact of Optimal Preparation Before Drug-Coated Balloon Dilatation for De Novo Lesion in Patients With Coronary Artery Disease.

ABSTRACT

BACKGROUND: Drug eluting stent (DES) remain several problems, including stent thrombosis, stent fracture and neoatherosclerosis. Stent-less Percutaneous coronary intervention (PCI) using a drug coated balloon (DCB) is a stent-less strategy, and several trials have supported the efficacy of DCB. However, the optimal preparation before using DCB was uncertain. The aim of this study was to investigate the optimal preparation for plaque oppression/debulking before DCB dilatation for de novo coronary artery lesion. METHODS: A total 936 patients were treated using DCB from 2014 to 2017 at our institution. Among them, we analyzed 247 patients who underwent PCI using DCB alone for de novo lesion. The primary end point of this study was target lesion failure (TLF). RESULTS: The area under the receiver operating characteristic (ROC) curve (AUC) was used to determine the optimal cutoff value of % plaque area to predict TLF. ROC curve analysis revealed plaque area ≥ 58.5% (AUC, 0.81) were associated with TLF. Eligible 188 patients were divided into 2 groups (plaque area ≥ 58.5% [n = 38] and <58.5% [n = 150]) according to IVUS data before using DCB. TLF was significantly higher in plaque area ≥ 58.5% group than in <58.5% group (P < 0.01). Multivariable analysis selected plaque area ≥ 58.5% as an independent predictor of TLF (hazard ratio 7.59, P < 0.01). CONCLUSIONS: Lesion preparation achieving plaque area < 58.5% was important in stent-less PCI using DCB.