A multicenter randomized controlled trial indicates that paclitaxel-coated balloons provide no benefit for arteriovenous fistulas
Kidney International Apr 19, 2021
Karunanithy N, Robinson EJ, Ahmad F, et al. - Researchers undertook this investigator-led multi-center randomized controlled trial to determine whether paclitaxel-coated angioplasty balloons are efficacious to prolong the survival time of target lesion primary patency in arteriovenous fistulas. Participants were patients with an arteriovenous fistula who were receiving an angioplasty for a clinical indication. Post-successful management with a high-pressure balloon, randomization of 212 patients was done. Primary analysis revealed no significant evidence for a difference in time to end of target lesion primary patency between the intervention arm (wherein the second component was insertion of a paclitaxel-coated balloon) and the control arm (in which an identical procedure was followed, but using a standard balloon). Overall, experts identified no evidence for a beneficial impact of paclitaxel-coated balloons, following standard care high-pressure balloon angioplasty, in the management of arteriovenous fistulas. Therefore, considering the advantage suggested by other trials, the role of paclitaxel-coated angioplasty balloons is uncertain.
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