Safety and efficacy of paclitaxel-coated balloons in treating dysfunctional arteriovenous fistulae

A recent study has shown that paclitaxel-coated balloons (AcoArt Orchid) exhibited improved primary patency rates when treating stenotic lesions in dysfunctional hemodialysis arteriovenous (AV) fistulae when compared to plain balloon angioplasty. This study’s findings were published in the Clinical journal of the American Society of Nephrology. 

This study was a prospective, multicenter, randomized controlled trial that included 244 patients who had ≥50% venous stenosis of the AV fistula and exhibited symptoms suggesting notable hemodynamic changes. Following a successful predilation using a high-pressure balloon (residual stenosis ≤30%), patients were randomly assigned to receive either the paclitaxel-coated balloon or the uncoated control balloon in a 1:1 ratio. The primary efficacy outcome was evaluated at 6 months, and safety assessment was conducted within 30 days of the procedure. Additionally, the 12-month results were also analyzed.

The drug-coated balloon (DCB) group achieved a primary target lesion patency rate of 91% (106/116), while the plain balloon catheter group had a rate of 67% (79/118), resulting in a difference of 24.63%. In terms of the secondary efficacy end point, the DCB group had a primary target lesion patency rate of 66% (74/112) at 12 months, whereas the plain balloon catheter group had a rate of 46% (52/112). Throughout the 12-month period following the index procedure, the DCB group required a mean number of 0.39 reinterventions per patient to maintain target lesion patency, compared to 0.77 reinterventions per patient in the plain balloon catheter group.

It can be concluded that the AcoArt Orchid DCB demonstrated better primary patency rates when compared to plain balloon angioplasty in the treatment of stenotic lesions in dysfunctional hemodialysis AV fistulae at both 6 and 12 months. Additionally, it necessitated fewer repeated interventions and exhibited comparable safety over the course of one year.