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Multicenter Study
. 2023 Jul 10;16(13):1640-1650.
doi: 10.1016/j.jcin.2023.05.002.

Device Effectiveness for Femoropopliteal Artery Disease Treatment: An Analysis of K-VIS ELLA Registry

Seung-Jun Lee  1 , Hyeok-Hee Lee  2 , Young-Guk Ko  3 , Chul-Min Ahn  1 , Yong-Joon Lee  1 , Jung-Sun Kim  1 , Byeong-Keuk Kim  1 , Myeong-Ki Hong  1 , Hyeon Chang Kim  4 , Cheol Woong Yu  5 , Jae-Hwan Lee  6 , Seung-Whan Lee  7 , Young Jin Youn  8 , Jong Kwan Park  9 , Chang-Hwan Yoon  10 , Seung Woon Rha  11 , Pil-Ki Min  12 , Seung-Hyuk Choi  13 , In-Ho Chae  10 , Donghoon Choi  1 ; K-VIS Investigators
Affiliations
Multicenter Study

Device Effectiveness for Femoropopliteal Artery Disease Treatment: An Analysis of K-VIS ELLA Registry

Seung-Jun Lee et al. JACC Cardiovasc Interv. .

Abstract

Background: Although drug-coated balloons (DCBs) and drug-eluting stents (DES) are frequently used for the treatment of femoropopliteal artery (FPA) disease, their mid- or long-term clinical efficacy in real-world practice is still limited.

Objectives: From the K-VIS ELLA (Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases) multicenter registry cohort, clinical outcomes of drug-eluting devices for FPA lesions in comparison with bare-metal stents (BMS) were evaluated.

Methods: Limbs that underwent percutaneous transluminal angioplasty for FPA lesions with plain old balloon angioplasty (POBA, n = 826), BMS (n = 943), DCBs (n = 778), or DES (n = 227) between 2012 and 2020 were included. The primary outcome was target lesion revascularization (TLR) at 2 years. Inverse probability of treatment weighting was used to account for confounding.

Results: After inverse probability of treatment weighting, baseline characteristics were well-balanced among groups. Compared with the 2-year cumulative incidence of TLR with BMS (26.5%), the incidence of TLR was significantly lower in limbs treated with DCBs (15.9%; HR: 0.44; 95% CI: 0.30-0.64; P < 0.001) or DES (15.9%; HR: 0.51; 95% CI: 0.29-0.87; P = 0.014). No significant differences were observed in the risk of TLR between DCBs vs DES (HR: 0.87; 95% CI: 0.51-1.49; P = 0.613) and POBA vs BMS (HR: 0.94; 95% CI: 0.73-1.21; P = 0.626). All-cause mortality was comparable in the 4 groups. Treatment with DCBs showed a more pronounced favorable outcome in limbs with Trans-Atlantic Inter-Society Consensus II type C/D lesions or long lesions (≥150 mm) compared with POBA, BMS, or DES (Pinteraction< 0.05).

Conclusions: In real-world practice, DCBs and DES demonstrated comparably superior midterm outcomes over POBA or BMS in the treatment of FPA lesions.

Keywords: drug-coated balloon; drug-eluting stent(s); endovascular; femoropopliteal artery disease; peripheral artery disease.

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Conflict of interest statement

Funding Support and Author Disclosures This study was supported by grants from the Patient-Centered Clinical Research Coordinating Center funded by the Ministry of Health and Welfare, Republic of Korea (grant HC20C0081); the Korea Medical Device Development Fund funded by the Korean government (grants 202011B29-03 and 202011D12-02); the Korea Health Technology R and D Project through the Korea Health Industry Development Institute (grant HI20C1566) and Bio and Medical Technology Development Program of the National Research Foundation and MSIT (grant 2020M3A9I4038455); and the Cardiovascular Research Center. Dr Ko has received research grants from Medtronic, Boston Scientific, Cook Medical, Samjin Pharm, Korea Otsuka Pharmaceutical, and Dong-A ST. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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