Propensity score-matched analysis of six-month outcomes of paclitaxel-coated balloons combined with UltraScore balloons versus conventional scoring balloons for femoropopliteal lesions.

ABSTRACT

PURPOSE: Combination angioplasty with paclitaxel-coated balloons (PCBs) and conventional scoring balloons for femoropopliteal lesions has demonstrated satisfactory results, even for complex lesions. The UltraScore balloon (Becton Dickinson, New Jersey, USA), which has a maximum length of 300 mm, has two longitudinal 0.010-inch stainless steel wires and is a new treatment option for complex femoropopliteal lesions. However, no studies have evaluated the effect of the UltraScore balloon on femoropopliteal lesions. This study aimed to compare the clinical efficacy of angioplasty over a six-month period using UltraScore balloons versus conventional scoring balloons for the treatment of atherosclerotic femoropopliteal lesions with PCBs. METHODS: A retrospective single-center observational study enrolled 272 patients who underwent PCB angioplasty combined with an UltraScore balloon (n = 58) or conventional scoring balloon (n = 214) without bailout stenting. Propensity score matching was used to minimize intergroup differences in baseline characteristics, and six-month outcomes were compared between the two groups. The primary endpoint was a technical success (i.e., residual angiographic stenosis of <30% with non-severe dissection). The secondary endpoints were the incidences of periprocedural complications, restenosis, and target lesion revascularization (TLR). RESULTS: After propensity score matching, 50 matched pairs of patients were selected for analysis. The UltraScore group had a significantly longer vessel length (192.8 ± 94.9 versus 36.6 ± 7.9 mm, P < 0.001), a lower frequency of non-compliant balloon (26.0% versus 56.0%, P = 0.002), and a smaller PCB diameter (5.32 ± 0.65 versus 5.66 ± 0.52 mm, P = 0.002) compared with the scoring group. The primary endpoint of technical success was significantly higher in the UltraScore group than in the scoring group (76.0% versus 56.0%, P = 0.035). There were no significant differences in periprocedural complications (4.0% versus 2.0%, P = 0.562), six-month restenosis (4.0% versus 8.0%, P = 0.339), and TLR (2.0% versus 4.0%, P = 0.500) between both groups. The multivariate logistic regression analysis showed that UltraScore use was independently associated with an increase in technical success (odds ratio 2.58; 95% confidence interval 1.05-6.36, P = 0.040). CONCLUSION: The use of an UltraScore balloon during PCB angioplasty for femoropopliteal lesions significantly improved technical success compared with conventional scoring balloons. UltraScore use was an independent predictor of technical success, indicating its potential advantages in peripheral intervention procedures.