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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 
 JACC-CARDIOVASCULAR INTERVENTIONS, Vol.16(13) : 1640-1650, 2023-07 
Journal Title
Issue Date
Angioplasty ; Femoral Artery* / diagnostic imaging ; Humans ; Registries ; Treatment Outcome ; Vascular Diseases*
drug-coated balloon ; drug-eluting stent(s) ; endovascular ; femoropopliteal artery disease ; peripheral artery disease
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Preventive Medicine (예방의학교실) > 1. Journal Papers
Yonsei Authors
Ko, Young Guk(고영국) ORCID logo https://orcid.org/0000-0001-7748-5788
Kim, Byeong Keuk(김병극) ORCID logo https://orcid.org/0000-0003-2493-066X
Kim, Jung Sun(김중선) ORCID logo https://orcid.org/0000-0003-2263-3274
Kim, Hyeon Chang(김현창) ORCID logo https://orcid.org/0000-0001-7867-1240
Ahn, Chul-Min(안철민) ORCID logo https://orcid.org/0000-0002-7071-4370
Lee, Seung-Jun(이승준) ORCID logo https://orcid.org/0000-0002-9201-4818
Lee, Yong Joon(이용준)
Lee, Hyeok-Hee(이혁희)
Choi, Dong Hoon(최동훈) ORCID logo https://orcid.org/0000-0002-2009-9760
Hong, Myeong Ki(홍명기) ORCID logo https://orcid.org/0000-0002-2090-2031
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