A multicenter randomized controlled trial indicates that paclitaxel-coated balloons provide no benefit during angioplasty of arteriovenous fistulas.
journal contributionposted on 29.04.2021, 11:13 by Narayan Karunanithy, Emily J Robinson, Farhan Ahmad, James O Burton, Francis Calder, Simon Coles, Neelanjan Das, Anthony Dorling, Colin Forman, Ounali Jaffer, Sarah Lawman, Raghuram Lakshminarayan, Rhys Lewlellyn, Janet L Peacock, Raymond Ramnarine, Irene Rebollo Mesa, Shoaib Shaikh, James Simpson, Kate Steiner, Rebecca Suckling, Laszlo Szabo, Douglas Turner, Ashar Wadoodi, Yanzhong Wang, Graeme Weir, C Jason Wilkins, Leanne M Gardner, Michael G Robson
The role of paclitaxel-coated balloons has been established in the coronary and peripheral arterial circulations with recent interest in the use of paclitaxel-coated balloons to improve patency rates following angioplasty of arteriovenous fistulas. To assess the efficacy of paclitaxel-coated angioplasty balloons to prolong the survival time of target lesion primary patency in arteriovenous fistulas, we designed an investigator-led multi-center randomized controlled trial with follow up time variable for a minimum of one year. Patients with an arteriovenous fistula who were undergoing an angioplasty for a clinical indication were included but patients with one or more lesions outside the treatment segment were excluded. Following successful treatment with a high-pressure balloon, 212 patients were randomized. In the intervention arm, the second component was insertion of a paclitaxel-coated balloon. In the control arm, an identical procedure was followed, but using a standard balloon. The primary endpoint was time to loss of clinically driven target lesion primary patency. Primary analysis showed no significant evidence for a difference in time to end of target lesion primary patency between groups: hazard ratio 1.18 with a 95% confidence interval of 0.78 to 1.79. There were no significant differences for any secondary outcomes, including patency outcomes and adverse events. Thus, our study demonstrated no evidence that paclitaxel-coated balloons provide benefit, following standard care high-pressure balloon angioplasty, in the treatment of arteriovenous fistulas. Hence, in view of the benefit suggested by other trials, the role of paclitaxel-coated angioplasty balloons remains uncertain.