Impact of drug-coated Balloon (DCB) on coronary de novo stenosis in large vessel remained to be clarified. Therefore, we conducted a single-center retrospective comparison of midterm clinical outcomes after elective use of DCB for stable de novo coronary stenosis in large vessel [post-procedural reference diameter >= 2.75 mm by quantitative coronary artery (QCA)] with those of drug-eluting stent (DES).

For this purpose, 17 variables including patient, lesion, and procedure characteristics, and quantitative coronary angiogram (QCA) were investigated in DCB (n=41) and DES (n=104) groups after successfully treatment during from 2017 December to 2019 March. The primary endpoint was the incidence of target lesion failure (TLF) comprising of cardiac death including sudden death, non-fatal myocardial infarction, and any target lesion revascularization including acute occlusion after DCB use and definite stent thrombosis after DES placement. The impact of DCB on TLF was estimated by adjusting the different values of 17 baseline variables using a Cox hazard proportional analysis.

The mean balloon size (3.24±0.44 mm) and total device length (18.0±2.8 mm) of DCB were significantly different from those of DES (3.56±0.34 mm, 35.3±19.4 mm, p < 0.001, respectively). The incidence of TLF in DCB group (7.3% during the mean observational interval of 607±306 days) was similar with that of DES group (6.7% during 270±246 days). Cumulated TLF-free ratio in DCB group was not significantly different from that in DES group (p=0.09, log-rank test). Hemodialysis was the single significant predictor of TLF [hazard ratio (HR): 46.6, 95% CI: 1.20-1810, p=0.040], although DCB (HR: 0.184, 95% CI: 0.01-6.60, p=0.354) was not.a

The present study showed the statistically equivalent midterm clinical outcome of DCB for de novo coronary stenosis in large vessel as with DES in a daily practice.