A multicenter randomized controlled trial indicates that paclitaxel-coated balloons provide no benefit for arteriovenous fistulas

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.

Citation

Karunanithy, N., Robinson, E. J., Ahmad, F., Burton, J. O., Calder, F., Coles, S., Das, N., Dorling, A., Forman, C., Jaffer, O., Lawman, S., Lakshminarayan, R., Lewlellyn, R., Peacock, J. L., Ramnarine, R., Mesa, I. R., Shaikh, S., Simpson, J., Steiner, K., Suckling, R., … Robson, M. G. (2021). A multicenter randomized controlled trial indicates that paclitaxel-coated balloons provide no benefit for arteriovenous fistulas. Kidney international, 100(2), 447–456. https://doi.org/10.1016/j.kint.2021.02.040

DOI

10.1016/j.kint.2021.02.040

URI

https://hdl.handle.net/20.500.14709/804

License

CC BY 4.0

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Usage rights

CC BY 4.0

License

https://creativecommons.org/licenses/by/4.0/