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Comparative Study
. 2025 Jul;66(7):412-420.
doi: 10.3349/ymj.2024.0166.

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

Jaeoh Lee  1 , Young-Guk Ko  2 , Seung-Jun Lee  1 , Sang-Hyup Lee  1 , Yong-Joon Lee  1 , Sung-Jin Hong  1 , Chul-Min Ahn  1 , Jung-Sun Kim  1 , Byeong-Keuk Kim  1 , Myeong-Ki Hong  1 , Cheol Woong Yu  3 , Jae-Hwan Lee  4 , Seung-Whan Lee  5 , Young Jin Youn  6 , Jong Kwan Park  7 , Chang-Hwan Yoon  8 , Seung Woon Rha  9 , Pil-Ki Min  10 , Seung-Hyuk Choi  11 , In-Ho Chae  8 , Donghoon Choi  1 ; K-VIS ELLA investigators
Affiliations
Comparative Study

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

Jaeoh Lee et al. Yonsei Med J. 2025 Jul.

Abstract

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.

Keywords: Peripheral artery disease; balloon angioplasty; paclitaxel; popliteal artery.

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Figures

Fig. 1
Fig. 1. Study flowchart. BMS, bare metal stent; DCB, drug-coated balloon; DES, drug-eluting stent; FPA, femoropopliteal artery; ISR, in-stent restenosis; K-VIS ELLA, the Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases; PAD, peripheral artery disease; POBA, plain old balloon angioplasty.
Fig. 2
Fig. 2. Primary outcome before and after inverse probability of treatment weighting. Target lesion revascularization before IPTW (A) and after IPTW (B). DCB, drug-coated balloon; HD, high-dose; IPTW, inverse probability of treatment weighting; LD, low-dose.
Fig. 3
Fig. 3. Secondary outcomes. Major adverse limb event (A) and all-cause death (B). DCB, drug-coated balloon; HD, high-dose; LD, low-dose.
See this image and copyright information in PMC

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