Paclitaxel-coated balloons compared to plain balloon angioplasty in the management of dysfunctional arteriovenous fistulae: A single-center randomized clinical trial

Abstract

The study aimed to compare paclitaxel-coated balloons (PCB) to percutaneous transluminal plain balloon angioplasty (PTA) in the management of dysfunctional arteriovenous fistulae. This single institution randomized controlled trial was approved by the institutional and local review boards and is registered in the ClinicalTrials.gov website. The study was initially designed to recruit a total of 92 patients. However, recruitment was terminated after the release of the meta-analysis that raised concerns about the potential increased risk of death associated with PCB. A total of 23 patients with nonthrombosed dysfunctional fistulae (mean age 67 years, 12 females) were recruited (PCB = 12) from October 2017 to September 2018. The fistulae were radiocephalic (n = 5), brachiocephalic (n = 12), brachiobasilic (n = 6), and seven immature fistulae. After a 2-min predilatation of the target lesions, patients were randomized to receive an additional 2-min of angioplasty with either a plain balloon or PCB (Lutonix). The primary endpoint was fistula patency at 12 months. The secondary endpoints included technical and clinical success, time-to-reintervention, survival at 12 months, and complications. The primary endpoint of fistula patency at 12 months was met in three patients treated with PCB and two patients treated with PTA. The all-cause mortality at one year was 8% (n = 2), both were in the PTA group. Treatment failed in restoring adequate fistula function in four patients [2 PCB with immature arteriovenous fistula (AVF) and two PTA with mature AVF]. Three patients were lost to follow-up (1 PCB, 2 PTA). Of the remaining patients (6 PCB and 4 PTA), there was no significant difference in the median time-toreintervention between the two groups (148 vs. 174 days). Two minor complications were recorded which did not require any additional treatment. Although this trial was terminated prematurely, there appears to be no significant difference between PCB and PTA in maintaining fistula patency and reducing the timeto- reintervention. No mortality was recorded in the PCB group during the study period.