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

  • Joongmin Kim (Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine) ;
  • Young-Guk Ko (Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine) ;
  • Seung-Jun Lee (Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine) ;
  • Chul-Min Ahn (Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine) ;
  • Seung-Woon Rha (Division of Cardiology, Cardiovascular Center, Korea University Guro Hospital) ;
  • Cheol Ung Choi (Division of Cardiology, Cardiovascular Center, Korea University Guro Hospital) ;
  • Pil-Ki Min (Division of Cardiology, Gangnam Severance Hospital, Yonsei University College of Medicine) ;
  • Jong Kwan Park (Division of Cardiology, National Health Insurance Service Ilsan Hospital) ;
  • Ji-Yong Jang (Division of Cardiology, National Health Insurance Service Ilsan Hospital) ;
  • Young Jin Youn (Division of Cardiology, Wonju Severance Hospital, Yonsei University Wonju College of Medicine) ;
  • Tae-Soo Kang (Division of Cardiology, Department of Internal Medicine, Dankook University College of Medicine) ;
  • Chang-Hwan Yoon (Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital) ;
  • Donghoon Choi (Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine)
  • 투고 : 2024.01.25
  • 심사 : 2024.04.17
  • 발행 : 2024.09.01

초록

Background and Objectives: The K-ELUVIA study aimed to investigate the clinical effectiveness and safety of EluviaTM, 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 EluviaTM 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.

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과제정보

We would like to thank Editage and ChatGPT for their linguistic assistance in improving the grammar and spelling of this manuscript.

참고문헌

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