Midterm safety and efficacy of elective drug-coated balloon angioplasty in comparison to drug-eluting stents for unrestrictive de novo coronary lesions: A single center retrospective study

Abstract

Background: The safety and efficacy of elective drug-coated balloon (DCB) angioplasty for unrestrictive de novo coronary stenosis in daily practice is not fully understood, especially in comparison to those of drug-eluting stents (DESs).

Methods: A total of 588 consecutive de novo coronary stenotic lesions electively and successfully treated with either DCB (n = 275) or DESs (n = 313) between January 2016 and December 2019 at our medical center were included. The primary safety endpoint was the incidence of target lesion failure (TLF), comprising cardiac death, non-fatal myocardial infarction, and target vessel revascularization. The secondary angiographic efficacy endpoint was angiographic restenosis frequency, defined as a follow-up percent diameter stenosis of >50. The endpoints were compared after baseline adjustment using propensity score matching. In addition, the frequency and predictors of late lumen enlargement (LLE), defined as minus late luminal loss, were examined in 201 crude angiographic follow-up lesions after DCB angioplasty.

Results: A total of 31 baseline parameters were adjusted to analyze 177 lesions in each group. The TLF frequencies (DCB group: 9.6 % during a mean observational interval of 789 ± 488 days vs. DES group: 10.2 %, 846 ± 484 days, p = 0.202) and cumulative TLF-free ratios of both groups were not significantly different (p = 0.892, log-rank test). The angiographic restenosis frequency in the DCB group (6.3 %, n = 128) was not significantly different from that of the DES group (10.1 %, n = 100, p = 0.593). LLE was observed in 45.3 % of entire lesions, and a type-A dissection was a significant predictor of LLE among 23 variables (odds ratio: 3.02, 95 % CI: 1.31-6.95, p = 0.010).

Conclusions: The present single-center retrospective study revealed statistically equivalent midterm clinical safety and angiographic efficacy among both elective DCB angioplasty and DESs placements in the treatment of unrestrictive de novo coronary lesions. In our daily practice environment, LLE was achieved in approximately half after DCB angioplasty.

Keywords: Coronary angioplasty; Drug-coated balloon; Drug-eluting stents; Follow-up results; Late lumen enlargement.