Paclitaxel-Coated Balloon Angioplasty of Venous Stenoses in Native Dialysis Fistulas: Primary and Secondary Patencies at 6 and 12 Months.
- Competence Center for Methodology and Statistics
Purpose: When dialysis access stenoses are dilated by noncoated balloons, respective primary and secondary patencies hardly reach 50 per cent and 85 per cent at one year. This study determines the primary and secondary patency rates at 6 and 12 months for venous stenoses treated by paclitaxel-coated balloon (PCB) angioplasty in native hemodialysis accesses. Materials and Methods: From 2012 to 2014, 70 venous stenoses in 41 patients benefited from PCB angioplasties. The patients' mean age was 62.5 +/- 13.8 years' standard deviation (SD) with 75 per cent male gender, 31.7 per cent diabetes, and 65.9 per cent arterial hypertension. There were 58.5 per cent forearm fistulas and 41.5 per cent arm fistulas. Primary and secondary patency rates were prospectively established by using the Kaplan-Meier technique and tested by using the log-rank test. Results: The primary patency rates +/- SD were 81.4 +/- 4.6 per cent and 60 +/- 5.9 per cent at 6 and 12 months, respectively. The secondary patency rates +/- SD reached 94.3 +/- 2.8 per cent at 6 months and 91.4 +/- 3.3 per cent at 12 months. Conclusion: This study shows an improvement of the primary and secondary patency rates at 6 and 12 months when venous stenoses of native dialysis fistulas are treated by PCB. The indications for PCB, however, remain to be established by larger randomized studies.