8:48 AM Abstract No. 76 - Paclitaxel-coated balloons in fistula. A prospective randomized controlled trial

Abstract

Purpose To report the interim (6-month) results of a prospective randomized controlled trial investigating angioplasty with paclitaxel-coated balloons (PCB) versus plain balloon angioplasty (PBA) for the treatment of failing arteriovenous fistulae (AVF). Materials and Methods From May 2011 to September 2012, 40 patients were randomly selected to undergo either PCB dilation (Group PCB, n=20) or PBA (Group PBA, n=20). Enrollment criteria included an angiographic and clinical diagnosis of dysfunctional AVF circuit due to at least one stenotic lesion. Regular angiographic follow-up was scheduled every 2 months. Study primary outcome measures included technical success (defined as residual stenosis of the treated lesion Results Baseline variables were equally distributed between the two groups. Technical success was 100% for both groups. To date, 6-month angiographic follow-up is available in 31 cases (14 in group PCB and 17 in group PBA). Interim calculation of the primary endpoint outcome by Kaplan-Meier survival analysis demonstrated a trend towards significantly higher primary patency in group PCB compared to group PBA (308 days vs. 167 days, respectively; p=0.14 by log rank test). Conclusion Interim study outcomes show that PCB angioplasty might constitute a valid solution in the treatment of failing arteriovenous fistulae. Long-term final data are awaited.