Highlights
- •Efficacy of drug-coated balloon (DCB) for de novo coronary lesions was examined.
- •Baselines were statistically adjusted in DCB and drug-eluting stent (DES) arms.
- •Frequencies of target lesion failure in both groups were statistically equivalent.
- •Mean late luminal loss was 0.07 mm with 45 % of late lumen enlargement in DCB group.
- •DCB angioplasty for adjusted de novo coronary lesions is feasible.
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.
Graphical abstract
Graphical Abstract
Keywords
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Article info
Publication history
Published online: February 04, 2023
Accepted:
November 8,
2022
Received in revised form:
November 5,
2022
Received:
August 2,
2022
Publication stage
In Press Corrected ProofIdentification
Copyright
© 2022 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.
