Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry
- Author:
Joongmin KIM
1
;
Young-Guk KO
;
Seung-Jun LEE
;
Chul-Min AHN
;
Seung-Woon RHA
;
Cheol Ung CHOI
;
Pil-Ki MIN
;
Jong Kwan PARK
;
Ji-Yong JANG
;
Young Jin YOUN
;
Tae-Soo KANG
;
Chang-Hwan YOON
;
Donghoon CHOI
Author Information
- Publication Type:Original Research
- From:Korean Circulation Journal 2024;54(9):565-576
- CountryRepublic of Korea
- Language:English
-
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.
