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

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...

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Autores principales: Haraguchi, Takuya, Tsujimoto, Masanaga, Otake, Ryo, Kashima, Yoshifumi, Sato, Katsuhiko, Fujita, Tsutomu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Galenos Publishing 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10679619/
https://www.ncbi.nlm.nih.gov/pubmed/37067068
http://dx.doi.org/10.4274/dir.2023.232114
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author Haraguchi, Takuya
Tsujimoto, Masanaga
Otake, Ryo
Kashima, Yoshifumi
Sato, Katsuhiko
Fujita, Tsutomu
author_facet Haraguchi, Takuya
Tsujimoto, Masanaga
Otake, Ryo
Kashima, Yoshifumi
Sato, Katsuhiko
Fujita, Tsutomu
author_sort Haraguchi, Takuya
collection PubMed
description 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.
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spelling pubmed-106796192023-12-05 Propensity score-matched analysis of six-month outcomes of paclitaxel-coated balloons combined with UltraScore balloons versus conventional scoring balloons for femoropopliteal lesions Haraguchi, Takuya Tsujimoto, Masanaga Otake, Ryo Kashima, Yoshifumi Sato, Katsuhiko Fujita, Tsutomu Diagn Interv Radiol Interventional Radiology - Original Article 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. Galenos Publishing 2023-05-31 /pmc/articles/PMC10679619/ /pubmed/37067068 http://dx.doi.org/10.4274/dir.2023.232114 Text en © Copyright 2023 by Turkish Society of Radiology | Diagnostic and Interventional Radiology, published by Galenos Publishing House. https://creativecommons.org/licenses/by-nc/4.0/Content of this journal is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. (https://creativecommons.org/licenses/by-nc/4.0/)
spellingShingle Interventional Radiology - Original Article
Haraguchi, Takuya
Tsujimoto, Masanaga
Otake, Ryo
Kashima, Yoshifumi
Sato, Katsuhiko
Fujita, Tsutomu
Propensity score-matched analysis of six-month outcomes of paclitaxel-coated balloons combined with UltraScore balloons versus conventional scoring balloons for femoropopliteal lesions
title Propensity score-matched analysis of six-month outcomes of paclitaxel-coated balloons combined with UltraScore balloons versus conventional scoring balloons for femoropopliteal lesions
title_full Propensity score-matched analysis of six-month outcomes of paclitaxel-coated balloons combined with UltraScore balloons versus conventional scoring balloons for femoropopliteal lesions
title_fullStr Propensity score-matched analysis of six-month outcomes of paclitaxel-coated balloons combined with UltraScore balloons versus conventional scoring balloons for femoropopliteal lesions
title_full_unstemmed Propensity score-matched analysis of six-month outcomes of paclitaxel-coated balloons combined with UltraScore balloons versus conventional scoring balloons for femoropopliteal lesions
title_short Propensity score-matched analysis of six-month outcomes of paclitaxel-coated balloons combined with UltraScore balloons versus conventional scoring balloons for femoropopliteal lesions
title_sort propensity score-matched analysis of six-month outcomes of paclitaxel-coated balloons combined with ultrascore balloons versus conventional scoring balloons for femoropopliteal lesions
topic Interventional Radiology - Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10679619/
https://www.ncbi.nlm.nih.gov/pubmed/37067068
http://dx.doi.org/10.4274/dir.2023.232114
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