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

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

doi:10.1186/s13063-016-1372-7

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

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

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Article number	241
Journal	Trials
Volume	17
Issue number	1
DOIs	https://doi.org/10.1186/s13063-016-1372-7
Publication status	Published - 12 May 2016

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Karunanithy, N., Mesa, I. R., Dorling, A., Calder, F., Katsanos, K., Semik, V., Robinson, E., Peacock, J., Das, N., Forman, C., Lawman, S., Steiner, K., Wilkins, C. J., & Robson, M. G. (2016). 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. Trials, 17(1), Article 241. https://doi.org/10.1186/s13063-016-1372-7

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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",

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.",

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

year = "2016",

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doi = "10.1186/s13063-016-1372-7",

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Karunanithy, N, Mesa, IR , Dorling, A , Calder, F, Katsanos, K, Semik, V , Robinson, E , Peacock, J, Das, N, Forman, C, Lawman, S, Steiner, K, Wilkins, CJ & Robson, MG 2016, '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', Trials, vol. 17, no. 1, 241. https://doi.org/10.1186/s13063-016-1372-7

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. / Karunanithy, Narayan; Mesa, Irene Rebollo ; Dorling, Anthony et al.
In: Trials, Vol. 17, No. 1, 241, 12.05.2016.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis (PAVE)

T2 - study protocol for a randomised controlled trial

AU - Karunanithy, Narayan

AU - Mesa, Irene Rebollo

AU - Dorling, Anthony

AU - Calder, Francis

AU - Katsanos, Konstantinos

AU - Semik, Vikki

AU - Robinson, Emily

AU - Peacock, Janet

AU - Das, Neelanjan

AU - Forman, Colin

AU - Lawman, Sarah

AU - Steiner, Kate

AU - Wilkins, C Jason

AU - Robson, Michael G

PY - 2016/5/12

Y1 - 2016/5/12

N2 - 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.

AB - 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.

U2 - 10.1186/s13063-016-1372-7

DO - 10.1186/s13063-016-1372-7

M3 - Article

C2 - 27175481

SN - 1745-6215

VL - 17

JO - Trials

JF - Trials

IS - 1

M1 - 241

ER -