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
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.
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Authors: Jaeoh Lee, In Tae Jin, Chul‐Min Ahn, Jae‐Hwan Lee, Pil‐Ki Min, Ji‐Yong Jang, Chang‐Hwan Yoon, Seung‐Whan Lee, Young Jin Youn, Cheol Woong Yu, Byung‐Hee Hwang, Ae‐Young Her, Jung‐Kyu Han, Sang-Min Kim, Woong Chol Kang, Wonmook Hwang, Eui Im, Y. Seo, Ju Han Kim, Tae‐Hoon Kim, Han‐Young Jin, Woo‐Young Chung, Byung Sik Kim, Chang-Bae Sohn, Seung‐Hyuk Choi, Donghoon Choi, Young‐Guk Ko, On behalf of the K-VIS ELLA investigators
Institutions: Chonnam National University Hospital, Chungbuk National University, Yonsei University, Ulsan College, Inje University Busan Paik Hospital, Kangwon National University, Seoul National University Bundang Hospital, Samsung Medical Center, University of Ulsan, Asan Medical Center, Seoul National University Hospital, Ajou University Hospital, Chungnam National University, Catholic University of Korea, Sungkyunkwan University, Korea University, Seoul National University, Severance Hospital, Gangnam Severance Hospital, The Catholic University of Korea Seoul St. Mary's Hospital, SNUH SMG-SNU Boramae Medical Center, Myongji Hospital, Chungnam National University Sejong Hospital, Hanyang University Guri Hospital, Seoul Metropolitan Government, National Health Insurance Service, National Health Insurance Service Ilsan Hospital, Wonju Severance Christian Hospital, Deleted Institution, Hanil General Hospital