Key result
PCB-P shows similar late luminal loss to PCB-S in small native coronary disease.
Why the study?
Does paclitaxel-coated balloon-P reduce late luminal loss compared to paclitaxel-coated balloon-S in patients with small native coronary vessel disease?
Cohort (n=344)
Yes
Does paclitaxel-coated balloon-P reduce late luminal loss compared to paclitaxel-coated balloon-S in patients with small native coronary vessel disease?
Absolute Event Rate: 0.01% vs 0.06%
p-value: p=0.30
PCB-P demonstrates comparable angiographic late luminal loss and clinical safety to PCB-S for the treatment of small native coronary vessel disease.
Background and purpose Drug-coated balloons (DCB) are a novel therapeutic strategy for small native coronary vessel disease (SVD). This study aimed to investigate the angiographic efficacy and clinical safety of paclitaxel-coated balloon-P (PCB-P) in SVD to enable regulatory approval by comparison with paclitaxel-coated balloon-S (PCB-S) which was approved for treatment of SVD. Methods Patients who have SVD treated with PCB-P were compared patients who have SVD treated with PCB-S in the DCB-ONLY trial. All patients underwent planned angiographic and clinical follow-up at 9 and 12 months, respectively. The primary endpoint was late luminal loss (LLL). Secondary endpoints included minimal lumen diameter (MLD), diameter stenosis (DS), restenosis rate and major adverse cardiac events (MACE). Results A total of 102 patients were treated with PCB-P and 242 patients were treated with PCB-S in the DCB-ONLY trial from 10 centers. After propensity score matching, 80 patients per group were included for analysis. The number of lesions treated was 82 in the PCB-P group and 85 in the PCB-S group. After the exclusion of 6 lesions due to bail-out stenting after balloon angioplasty (PCB-P: 1 lesion, PCB-S: 5 lesions), final 84 lesions in the PCB-P group and 77 lesions in the PCB-S group were analyzed. The LLL at angiographic follow-up was 0.01±0.18 mm in the PCB-P group and 0.06±0.52 mm in the PCB-S group, respectively. There was no statistical significance (p=0.30). However, greater MLD (1.99±1.88 mm vs. 1.42±0.53 mm, p<0.001), lower DS (27.7±8.0% vs. 48.3±45.3%, p<0.001) and lower restenosis rate (2.4% vs. 17.0%, p=0.004) were noted in the PCB-P group compared to the PCB-S group. These differences might come from results of lesion preparation prior to DCB angioplasty between two groups. Higher inflation pressure with pre-dilatation balloon (p< 0.001), DCB balloon (p=0.001) and longer inflation duration (p < 0.001) of DCB angioplasty were noted in the PCB-P group compared to the PCB-S group. The incidence of MACE was comparable between both groups (2.5% vs. 5.0%, p=0.68). Conclusions This study showed that PCB-P is effective and safe for the treatment of SVD which is comparable with outcomes of PCB-S
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Lee et al. (2025) conducted a cohort in small native coronary vessel disease (SVD) (n=344). paclitaxel-coated balloon-P (PCB-P) vs. paclitaxel-coated balloon-S (PCB-S) was evaluated on late luminal loss (LLL) (p=0.30). Paclitaxel-coated balloon-P resulted in similar late luminal loss compared to paclitaxel-coated balloon-S in small native coronary vessel disease (0.01±0.18 mm vs 0.06±0.52 mm, p=0.30).
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