The optimal postprocedural percent diameter stenosis (post%DS) after drug-coated balloon (DCB) angioplasty has been consistently proposed as < 30, which referred as the stent like results of DCB angioplasty. However, this quantitative coronary angiogram (QCA)-related DCB angioplasty endpoint has not been re-estimated so far as approximately two decades. Therefore, we sought to retrospectively evaluate the impact of post%DS of 30 on cumulative cardiovascular outcomes after elective and successful DCB angioplasty to de novo coronary stenosis in our pooled data.

This study was a single center, retrospective, and lesion-based observational study collecting the data of non-randomized DCB angioplasty in our daily practice. Over more than 7 years from 2016 January to 2023 March, 2974 lesions in 2399patients were treated with PCI. Of them, 2059 lesions were electively treated,129 lesions were not successfully treated by PCI. During this period, DCB angioplastyfor 493 lesions, drug-eluting stents (DESs) placement for 1267 lesionsincluding 32 lesions for the bailout of DCB angioplasty, balloon angioplastyfor 153 lesions, bare-metal stents (BMSs) placement for 16 lesions including 10for the bailout of DCB angioplasty, and 1 lesion for thrombectomy use. Of thelesions of DCB angioplasty, not de novo lesions (n=152) were excluded. Therefore, the present study includedconsecutive 341 de novo coronary lesions successfully treated by DCB angioplasty in 257patients by the elective procedures without bailout stenting.The clinical primary endpoint was defined as 3-year cumulative target lesion failure (TLF) comprising of cardiac mortality and target vessel revascularization (TVR). The cohort was divided into the optimal result group (post%DS<30) and the suboptimal result group (post%DS>=30) group. Impact of suboptimal treatment on 3-yr cumulative TLF was examined by multivariate Cox proportional hazard model by including 37 variables. Multivariate logistic regression analysis was conducted to define the predictors of suboptimal result.

The whole cohort was divided into the optimal (n=251) and the suboptimal (n=90) result groups. The frequency of TLF in the optimal result group (6.0% with the mean follow-up interval of 818 ± 364 days) was significantly lower than that of the suboptimal result group (17.8%, p<0.001, 752 ± 401 days). 3-yr TLF free ratio of the optimal result group was significantly higher than that of the suboptimal result group (p=0.0014 by log-rank test). Suboptimal result was one of the significant predictors of 3-yr TLF (hazard ratio [HR]: 3.04, 95%CI:1.43-6.48, p=0.004), as with proximal tortuous lesion and previous heart failure. Calcification was a single predictor of the suboptimal result (odds ratio: 3.33, 95%CI: 1.43-7.75, p=0.005).

The present observational study reconfirmed the validity of the cutoff post%DS value of 30 as the optimal endpoint related to the 3-yr cumulative TLF incideces after elective DCB angioplasty for de novo coronary lesions.