Three-Year Outcomes of Drug-Eluting Stents, Drug-Coated Balloons, and Non-Drug-Eluting Devices in Native Femoropopliteal Artery Disease: An Analysis of the K-VIS ELLA Registry

Background: Although drug-eluting devices have demonstrated improved efficacy in femoropopliteal artery (FPA) disease, evidence on their long-term clinical outcomes in realworld practice remains limited.Methods: Using data from the multicenter Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Disease registry, 4,193 symptomatic native FPA limbs were analyzed.Treatments included non-drug-eluting devices, comprising plain old balloon angioplasty (n = 1,194) and bare-metal stents (n = 1,510), and drug-eluting devices, comprising drug-eluting stents (DES; n = 347) and drug-coated balloons (DCB; n = 1,142).The primary endpoint was clinically driven target lesion revascularization (CD-TLR) at 3 years.Inverse probability of treatment weighting was used to balance baseline characteristics.Results: After weighting, baseline characteristics were well balanced across groups.The mean patient age was 69.7 years, the mean lesion length was approximately 170.4 mm, and 59% of lesions were classified as Trans-Atlantic Inter-Society Consensus II C/D.At 3 years, DES and DCB were associated with significantly lower cumulative incidences of CD-TLR than non-drug-eluting devices (DES, 22.4% vs. 26.5%;adjusted hazard ratio [HR], 0.62; 95% confidence interval [CI], 0.42-0.91;P = 0.014; DCB, 20.5% vs. 26.5%;adjusted HR, 0.54; 95% CI, 0.40-0.73;P < 0.001).The CD-TLR rate did not differ significantly between DES and DCB.Rates of major amputation and all-cause mortality were similar across groups.Conclusions: In patients with symptomatic native FPA disease, endovascular treatment with DES or DCB was associated with a lower 3-year risk of CD-TLR than treatment with nondrug-eluting devices, without an increased risk of mortality.

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Publication Details

Journal
Journal of Cardiovascular Intervention
Published
2026-09-10
DOI
https://doi.org/10.54912/jci.2026.0031
Primary Topic
Peripheral Artery Disease Management
Type
article
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article

Three-Year Outcomes of Drug-Eluting Stents, Drug-Coated Balloons, and Non-Drug-Eluting Devices in Native Femoropopliteal Artery Disease: An Analysis of the K-VIS ELLA Registry

Eui Im, Jung‐Kyu Han, Byung Sik Kim, Ae‐Young Her et al.
Journal of Cardiovascular Intervention
Peripheral Artery Disease Management
article

Three-Year Outcomes of Drug-Eluting Stents, Drug-Coated Balloons, and Non-Drug-Eluting Devices in Native Femoropopliteal Artery Disease: An Analysis of the K-VIS ELLA Registry

Eui Im, Jung‐Kyu Han, Byung Sik Kim, Ae‐Young Her, Seung‐Hyuk Choi, Woo‐Young Chung, Donghoon Choi, In Tae Jin, Wonmook Hwang, Chang-Bae Sohn, Cheol Woong Yu, Ji‐Yong Jang, Han‐Young Jin, Ju Han Kim, Byung‐Hee Hwang, Pil‐Ki Min, Young Jin Youn, Chang‐Hwan Yoon, Woong Chol Kang, Seung‐Whan Lee, Young‐Guk Ko, Chul‐Min Ahn, Tae‐Hoon Kim, Jae‐Hwan Lee, Sang-Min Kim, Jaeoh Lee, Y. Seo, On behalf of the K-VIS ELLA investigators
article en

Abstract

Background: Although drug-eluting devices have demonstrated improved efficacy in femoropopliteal artery (FPA) disease, evidence on their long-term clinical outcomes in realworld practice remains limited.Methods: Using data from the multicenter Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Disease registry, 4,193 symptomatic native FPA limbs were analyzed.Treatments included non-drug-eluting devices, comprising plain old balloon angioplasty (n = 1,194) and bare-metal stents (n = 1,510), and drug-eluting devices, comprising drug-eluting stents (DES; n = 347) and drug-coated balloons (DCB; n = 1,142).The primary endpoint was clinically driven target lesion revascularization (CD-TLR) at 3 years.Inverse probability of treatment weighting was used to balance baseline characteristics.Results: After weighting, baseline characteristics were well balanced across groups.The mean patient age was 69.7 years, the mean lesion length was approximately 170.4 mm, and 59% of lesions were classified as Trans-Atlantic Inter-Society Consensus II C/D.At 3 years, DES and DCB were associated with significantly lower cumulative incidences of CD-TLR than non-drug-eluting devices (DES, 22.4% vs. 26.5%;adjusted hazard ratio [HR], 0.62; 95% confidence interval [CI], 0.42-0.91;P = 0.014; DCB, 20.5% vs. 26.5%;adjusted HR, 0.54; 95% CI, 0.40-0.73;P < 0.001).The CD-TLR rate did not differ significantly between DES and DCB.Rates of major amputation and all-cause mortality were similar across groups.Conclusions: In patients with symptomatic native FPA disease, endovascular treatment with DES or DCB was associated with a lower 3-year risk of CD-TLR than treatment with nondrug-eluting devices, without an increased risk of mortality.

Journal of Cardiovascular InterventionVol. 6
Ulsan College (KR), Seoul National University (KR), Chungbuk National University (KR), Kangwon National University (KR), Yonsei University (KR), Chungnam National University (KR), Korea University (KR), Severance Hospital (KR), Seoul Metropolitan Government (KR), Asan Medical Center (KR), Samsung Medical Center (KR), Seoul National University Hospital (KR), Seoul National University Bundang Hospital (KR), University of Ulsan (KR), Chonnam National University Hospital (KR), SNUH SMG-SNU Boramae Medical Center (KR), Wonju Severance Christian Hospital (KR), Ajou University Hospital (KR), Inje University Busan Paik Hospital (KR), Hanil General Hospital (KR), Hanyang University Guri Hospital (KR), National Health Insurance Service Ilsan Hospital (KR), Myongji Hospital (KR), Gangnam Severance Hospital (KR), National Health Insurance Service (KR), The Catholic University of Korea Seoul St. Mary's Hospital (KR), Deleted Institution, Chungnam National University Sejong Hospital (KR), Sungkyunkwan University (KR), Catholic University of Korea (KR)
Korea Medical Device Development Fund, Ministry of Trade, Industry and Energy, Ministry of Food and Drug Safety, Ministry of Science and ICT, South Korea
Openalex Percentile: Top 9%
Peripheral Artery Disease Management
DOIOpen Access PDFOpenAlex
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