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

Seung-Jun Lee; Hyeok-Hee Lee; Young-Guk Ko; Chul-Min Ahn; Yong-Joon Lee; Jung-Sun Kim; Byeong-Keuk Kim; Myeong-Ki Hong; Hyeon Chang Kim; 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 Investigators

doi:10.1016/j.jcin.2023.05.002

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

JACC Cardiovasc Interv. 2023 Jul 10;16(13):1640-1650. doi: 10.1016/j.jcin.2023.05.002.

Authors

Seung-Jun Lee¹, Hyeok-Hee Lee², Young-Guk Ko³, Chul-Min Ahn¹, Yong-Joon Lee¹, Jung-Sun Kim¹, Byeong-Keuk Kim¹, Myeong-Ki Hong¹, Hyeon Chang Kim⁴, Cheol Woong Yu⁵, Jae-Hwan Lee⁶, Seung-Whan Lee⁷, Young Jin Youn⁸, Jong Kwan Park⁹, Chang-Hwan Yoon¹⁰, Seung Woon Rha¹¹, Pil-Ki Min¹², Seung-Hyuk Choi¹³, In-Ho Chae¹⁰, Donghoon Choi¹; K-VIS Investigators

Affiliations

¹ Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
² Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea; Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Korea.
³ Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea. Electronic address: ygko@yuhs.ac.
⁴ Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Korea.
⁵ Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea.
⁶ Cardiovascular Center, Department of Cardiology in Internal Medicine, Chungnam National University Sejong Hospital, Chungnam National University School of Medicine, Daejeon, South Korea.
⁷ Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea.
⁸ Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.
⁹ Division of Cardiology, Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea.
¹⁰ Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea; Department of Cardiology, Seoul National University Bundang Hospital, Seongnam, South Korea.
¹¹ Cardiovascular Center, Division of Cardiology, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.
¹² Division of Cardiology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
¹³ Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.

PMID: 37438031
DOI: 10.1016/j.jcin.2023.05.002

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 (P_interaction< 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.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Angioplasty
Femoral Artery* / diagnostic imaging
Humans
Registries
Treatment Outcome
Vascular Diseases*