Multicenter,Randomized Trial of Conventional Balloon Angioplasty versus Paclitaxel-Coated Balloon Angioplasty for the Treatment of Dysfunctioning Autologous Dialysis Fistulae |
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Authors: | Geert Maleux Ward Vander Mijnsbrugge Denis Henroteaux Annouschka Laenen Sandra Cornelissen Kathleen Claes Inge Fourneau Nicolas Verbeeck |
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Affiliation: | 1. Department of Radiology, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium;2. Department of Nephrology, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium;3. Department of Vascular Surgery, University Hospitals Leuven, Herestraat 49, B-3000 Leuven, Belgium;4. Department of Radiology, Centre Hospitalier Régional La Citadelle, Liège, Belgium;5. Interuniversity Centre for Biostatistics and Statistical Bioinformatics, Catholic University of Leuven and University Hasselt, Belgium;6. Department of Radiology, Centre Hospitalier Régional, Luxembourg, Luxembourg |
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Abstract: | PurposeTo investigate the potential added value of paclitaxel-coated balloon (PCB) angioplasty to reduce fistula dysfunction related to recurrent stenoses in patients undergoing hemodialysis.Materials and MethodsA prospective, randomized study was conducted in 3 dialysis referral centers. From January 2013 to October 2015, 64 patients (22 female, 42 male) with dysfunctional autologous dialysis fistulae were randomized to undergo conventional percutaneous balloon angioplasty (n = 31) or PCB angioplasty (n = 33). Procedural and postprocedural data were assessed. Primary patency of the fistula was evaluated at 3, 6, and 12 months following the procedure. Statistical analysis was based on the Fisher exact test and independent t test.ResultsThere were no procedural or postprocedural complications. After 3, 6, and 12 months of follow-up, primary patency rates after PCB angioplasty and percutaneous transluminal angioplasty (PTA) were 88% and 80% (P = .43), 67% and 65% (P = .76), and 42% and 39% (P = .95), respectively.ConclusionsAlthough primary patency rates after PCB angioplasty in autologous dialysis fistulae at 3, 6, and 12 months of follow-up are slightly better than those after PTA, the difference is not statistically significant. |
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Keywords: | AVF arteriovenous fistula KDOQI Kidney Disease Outcomes Quality Initiative PCB paclitaxel-coated balloon PTA percutaneous transluminal angioplasty |
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