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

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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) https://orcid.org/0000-0001-7748-5788
Kim, Byeong Keuk(김병극) https://orcid.org/0000-0003-2493-066X
Kim, Jung Sun(김중선) https://orcid.org/0000-0003-2263-3274
Min, Pil Ki(민필기) https://orcid.org/0000-0001-7033-7651
Ahn, Chul-Min(안철민) https://orcid.org/0000-0002-7071-4370
Lee, Sanghyup(이상협)
Lee, Seung-Jun(이승준) https://orcid.org/0000-0002-9201-4818
Choi, Dong Hoon(최동훈) https://orcid.org/0000-0002-2009-9760
Hong, Myeong Ki(홍명기) https://orcid.org/0000-0002-2090-2031
Hong, Sung Jin(홍성진) https://orcid.org/0000-0003-4893-039X

URI: https://ir.ymlib.yonsei.ac.kr/handle/22282913/207552

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