Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: A prospective randomized controlled trial
- Authors
- Kim, J.W.; Kim, J.H.; Byun, S.S.; Kang, J.M.; Shin, J.H.
- Issue Date
- Nov-2020
- Publisher
- Korean Radiological Society
- Keywords
- Angioplasty; Arteriovenous fistula; Hemodialysis; Paclitaxel drug-coated balloon; Patency
- Citation
- Korean Journal of Radiology, v.21, no.11, pp.1239 - 1247
- Journal Title
- Korean Journal of Radiology
- Volume
- 21
- Number
- 11
- Start Page
- 1239
- End Page
- 1247
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/78300
- DOI
- 10.3348/kjr.2020.0067
- ISSN
- 1229-6929
- 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. © 2020 The Korean Society of Radiology.
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