Korean Journal of Radiology

The Korean Society of Radiology (대한영상의학회)
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Paclitaxel-Coated Balloon versus Plain Balloon Angioplasty for Dysfunctional Autogenous Radiocephalic Arteriovenous Fistulas: A Prospective Randomized Controlled Trial

  • Jong Woo Kim (Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Jeong Ho Kim (Department of Radiology Gil Medical Center, Gachon University College of Medicine) ;
  • Sung Su Byun (Health Promotion Center, Inha University Hospital) ;
  • Jin Mo Kang (Department of Surgery Gil Medical Center, Gachon University College of Medicine) ;
  • Ji Hoon Shin (Department of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine)
  • Received : 2020.01.29
  • Accepted : 2020.04.07
  • Published : 2020.11.01
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Abstract

Objective: To report the mid-term results of a single-center randomized controlled trial comparing drug-coated balloon angioplasty (DBA) and plain balloon angioplasty (PBA) for the treatment of dysfunctional radiocephalic arteriovenous fistulas (RCAVFs). Materials and Methods: In this prospective study, 39 patients (mean age, 62.2 years; 21 males, 18 females) with RCAVFs failing due to juxta-anastomotic stenosis were randomly assigned to undergo either both DBA and PBA (n = 20, DBA group) or PBA alone (n = 19, PBA group) between June 2016 and June 2018. Primary endpoints were technical and clinical success and target lesion primary patency (TLPP); secondary outcomes were target lesion secondary patency (TLSP) and complication rates. Statistical analysis was performed using the Kaplan-Meier product limit estimator. Results: Demographic data and baseline clinical characteristics were comparable between the groups. Technical and clinical success rates were 100% in both groups. There was no significant difference between the groups in the mean duration of TLPP (DBA group: 26.7 ± 3.6 months; PBA group: 27.0 ± 3.8 months; p = 0.902) and TLSP (DBA group: 37.3 ± 2.6 months; PBA group: 40.4 ± 1.5 months; p = 0.585). No procedural or post-procedural complications were identified. Conclusion: Paclitaxel-coated balloon use did not significantly improve TLPP or TLSP in the treatment of juxta-anastomotic stenosis of dysfunctional RCAVFs.

Keywords

Acknowledgement

This study was supported by the Dong Kook Lifescience. Co., Ltd., Republic of Korea (2016-38).

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