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Comparison of High-Dose versus Low-Dose Paclitaxel Drug-Coated Balloons for Native Femoropopliteal Artery Disease: An Analysis of the K-VIS ELLA Registry

Authors
 Jaeoh Lee  ;  Young-Guk Ko  ;  Seung-Jun Lee  ;  Sang-Hyup Lee  ;  Yong-Joon Lee  ;  Sung-Jin Hong  ;  Chul-Min Ahn  ;  Jung-Sun Kim  ;  Byeong-Keuk Kim  ;  Myeong-Ki Hong  ;  Cheol Woong Yu  ;  Jae-Hwan Lee  ;  Seung-Whan Lee  ;  Young Jin Youn  ;  Jong Kwan Park  ;  Chang-Hwan Yoon  ;  Seung Woon Rha  ;  Pil-Ki Min  ;  Seung-Hyuk Choi  ;  In-Ho Chae  ;  Donghoon Choi  ;  K-VIS ELLA investigators 
Citation
 YONSEI MEDICAL JOURNAL, Vol.66(7) : 412-420, 2025-07 
Journal Title
YONSEI MEDICAL JOURNAL
ISSN
 0513-5796 
Issue Date
2025-07
MeSH
0
Keywords
Aged ; Aged, 80 and over ; Female ; Femoral Artery* / pathology ; Femoral Artery* / surgery ; Humans ; Male ; Middle Aged ; Paclitaxel* / administration & dosage ; Paclitaxel* / therapeutic use ; Peripheral Arterial Disease* / drug therapy ; Popliteal Artery* / drug effects ; Popliteal Artery* / pathology ; Popliteal Artery* / surgery ; Registries ; Treatment Outcome
Abstract
Peripheral artery disease ; balloon angioplasty ; paclitaxel ; popliteal artery
Article Number
 10.3349/ymj.2024.0166 
DOI
Purpose: Drug-coated balloons (DCBs) have demonstrated favorable outcomes in the treatment of femoropopliteal artery (FPA) disease. A variety of DCBs are currently available, with differing doses of antiproliferative agents and types of excipients. The objective of this study was to compare the efficacy and safety of high-dose versus low-dose paclitaxel DCBs for the treatment of FPA disease. Materials and methods: We analyzed data from the multicenter the Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases (K-VIS ELLA) registry, focusing on patients treated with a high-dose paclitaxel DCB (IN.PACT™) or low-dose paclitaxel DCB (Lutonix™ or Ranger™) for native vessel FPA disease. We used inverse probability of treatment weighting to adjust for confounding factors and conducted subgroup analyses based on lesion characteristics. Results: Among 820 target limbs, 626 were treated with a high-dose paclitaxel DCB, and 194 were treated with a low-dose paclitaxel DCB. At 12 months, there were no significant differences in rates of freedom from clinically driven target lesion revascularization (TLR; 91.7% vs. 89.4%, log-rank p=0.35), major adverse limb event (MALE; 91.4% vs. 89.0%, log-rank p=0.31), or all-cause mortality (93.1% vs. 93.8%, log-rank p=0.79) between high-dose and low-dose groups. On multivariable analysis, the presence of chronic heart failure and chronic kidney disease were the only independent predictors of clinically driven TLR after DCB treatment. Conclusion: In this multicenter cohort study of patients with complex FPA disease, there were no significant differences between high-dose DCB and low-dose DCB with respect to freedom from clinically driven TLR, MALE, or all-cause mortality at 12-month follow-up.
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Ko, Young Guk(고영국) ORCID logo https://orcid.org/0000-0001-7748-5788
Kim, Byeong Keuk(김병극) ORCID logo https://orcid.org/0000-0003-2493-066X
Kim, Jung Sun(김중선) ORCID logo https://orcid.org/0000-0003-2263-3274
Min, Pil Ki(민필기) ORCID logo https://orcid.org/0000-0001-7033-7651
Ahn, Chul-Min(안철민) ORCID logo https://orcid.org/0000-0002-7071-4370
Lee, Sanghyup(이상협)
Lee, Seung-Jun(이승준) ORCID logo https://orcid.org/0000-0002-9201-4818
Choi, Dong Hoon(최동훈) ORCID logo https://orcid.org/0000-0002-2009-9760
Hong, Myeong Ki(홍명기) ORCID logo https://orcid.org/0000-0002-2090-2031
Hong, Sung Jin(홍성진) ORCID logo https://orcid.org/0000-0003-4893-039X
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/207552
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