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Open Access 01-12-2016 | Study protocol

Paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis (PAVE): study protocol for a randomised controlled trial

Authors: Narayan Karunanithy, Irene Rebollo Mesa, Anthony Dorling, Francis Calder, Konstantinos Katsanos, Vikki Semik, Emily Robinson, Janet Peacock, Neelanjan Das, Colin Forman, Sarah Lawman, Kate Steiner, C Jason Wilkins, Michael G Robson

Published in: Trials | Issue 1/2016

Abstract

Background

The initial therapy for a stenosis in an arteriovenous fistula used for haemodialysis is radiological balloon dilatation or angioplasty. The benefit of angioplasty is often short-lived, intervention-free survival is reported to be 40–50 % at 1 year. Previous small studies and observational data suggest that paclitaxel-coated balloons may be of benefit in improving outcomes after fistuloplasty of stenotic arteriovenous fistulae.

Methods/design

We have designed a multicentre, double-blind randomised controlled trial to test the superiority of paclitaxel-coated balloons for preventing restenosis after fistuloplasty in patients with a native arteriovenous fistula. Two hundred and eleven patients will be followed up for a minimum of 1 year. Inclusion criteria include a clinical indication for a fistuloplasty, an access circuit that is free of synthetic graft material or stents, and a residual stenosis of 30 % or less after plain balloon fistuloplasty. Exclusion criteria include a synchronous venous lesion in the same access circuit, location of the stenosis central to the thoracic inlet or a thrombosed access circuit at the time of treatment. The primary endpoint is time to end of target lesion primary patency. This is defined as a clinically-driven radiological or surgical re-intervention at the treatment segment, thrombosis that includes the treatment segment, or abandonment of the access circuit due to an inability to re-treat the treatment segment. Secondary endpoints include angiographic late lumen loss, time to end of access circuit cumulative patency, the total number of interventions, and quality of life. The trial is funded by the National Institute for Health Research.

Discussion

We anticipate that this trial will provide rigorous data that will determine the efficacy of additional paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis.

Trial registration

ISRCTN14284759. Registered on 28 October 2015.

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Title: Paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis (PAVE): study protocol for a randomised controlled trial
Authors: Narayan Karunanithy
Irene Rebollo Mesa
Anthony Dorling
Francis Calder
Konstantinos Katsanos
Vikki Semik
Emily Robinson
Janet Peacock
Neelanjan Das
Colin Forman
Sarah Lawman
Kate Steiner
C Jason Wilkins
Michael G Robson
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-016-1372-7

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Paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis (PAVE): study protocol for a randomised controlled trial

Abstract

Background

Methods/design

Discussion

Trial registration

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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