Korean Circ J.  2024 Sep;54(9):565-576. 10.4070/kcj.2024.0038.

Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry

• Kim J
• Ko YG
• Lee SJ
• Ahn CM
• Rha SW
• Choi CU
• Min PK
• Park JK
• Jang JY
• Youn YJ
• Kang TS
• Yoon CH
• Choi D

• KMID: 2559129
• DOI: http://doi.org/10.4070/kcj.2024.0038

Abstract

Background and Objectives
The K-ELUVIA study aimed to investigate the clinical effectiveness and safety of Eluvia™, a polymer-coated, paclitaxel-eluting stent, for femoropopliteal artery disease using data from a prospective Korean multicenter registry.
Methods
A total of 105 patients with femoropopliteal artery disease who received endovascular treatment (EVT) with Eluvia™ stents at 7 Korean sites were enrolled in a prospective cohort and followed for 2 years. The primary endpoint was the 2-year clinical patency. The secondary endpoint was 2-year freedom from clinically driven target lesion revascularization (TLR).
Results
Mean patient age was 68.2±10.4 years, and most patients (82.7%) were male. Mean lesion length was 168.3±117.6 mm. Chronic total occlusion was found in 57.7% of patients. Trans-Atlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) type C or D lesions were present in 46.1% of patients. Procedural success was achieved in 99.0% of patients. The clinical patency rate was 84.4% at 1 year after EVT and 76.3% at 2 years post-EVT. The freedom from TLR rate was 89.1% at 1 year after EVT and 79.1% at 2 years post-EVT. Chronic total occlusion (hazard ratio [HR], 3.53; 95% confidence interval [CI], 1.08–11.67; p=0.039) and smaller mean stent diameter (HR, 0.40; 95% CI, 0.16– 0.98; p=0.044) were identified as independent predictors of loss of clinical patency at 2 years.
Conclusions
The K-ELUVIA study demonstrated favorable 2-year clinical effectiveness and safety outcomes of Eluvia stent for femoropopliteal artery lesions in real-world practice.

Keyword

Peripheral artery disease; Angioplasty

Figure

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  Figure 1 Patient flow chart of the K-ELUVIA study.

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  Figure 2 Distribution of Rutherford categories before endovascular treatment, after the procedure, and during follow-up.

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  Figure 3 Kaplan-Meier curves and estimates of clinical patency over time (A) and TLR free–survival (B).EVT = endovascular treatment; TLR = target lesion revascularization.

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  Figure 4 Kaplan-Meier curves and estimates of clinical patency over time according to lesion characteristics. Total occluded lesion (A), TASC II classification (B), lesion length (C), and calcification (D).EVT = endovascular treatment; PACSS = Peripheral Arterial Calcium Scoring System; TASC II = Trans-Atlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease.

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