@article{444ff223f50941ada03a3967998ba60c,
title = "A multicenter randomized controlled trial indicates that paclitaxel-coated balloons provide no benefit for arteriovenous fistulas",
abstract = "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.",
keywords = "angioplasty, arteriovenous fistula, dialysis, fistuloplasty, paclitaxel",
author = "Narayan Karunanithy and Robinson, {Emily J} and Farhan Ahmad and Burton, {James O} and Francis Calder and Simon Coles and Neelanjan Das and Anthony Dorling and Colin Forman and Ounali Jaffer and Sarah Lawman and Raghuram Lakshminarayan and Rhys Lewlellyn and Peacock, {Janet L} and Raymond Ramnarine and Mesa, {Irene Rebollo} and Shoaib Shaikh and James Simpson and Kate Steiner and Rebecca Suckling and Laszlo Szabo and Douglas Turner and Ashar Wadoodi and Yanzhong Wang and Graeme Weir and Wilkins, {C Jason} and Gardner, {Leanne M} and Robson, {Michael G}",
note = "Funding Information: This project (project 13/94/10) is funded by the Efficacy and Mechanism Evaluation Programme, a Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership. The views expressed in this publication are those of the authors and not necessarily those of the MRC, NIHR, or the Department of Health and Social Care. High-pressure, drug-coated, and control balloons were supplied by CR Bard (Becton Dickinson and Company), which had no other role in the study. EJR received salary support from the NIHR Biomedical Research Centre, based at Guy's and St Thomas' NHS Foundation Trust and King's College London. We are grateful to Vikki Semik, Charlotte Bailey, and Micheala Curran for work on trial management; Konstantinos Katsanos for work in planning the study; and members of the data monitoring and trial steering committees. These committee members were Duncan Ettles, Richard Haynes, Thomas Hiemstra, Peter Littler, Andrew McGrath, Sandip Mitra, David Oliviera, Nick Palmer, Uday Patel, Isabel Reading, Max Troxler, Christopher Watson, and Andrew Wigham. Further details on committee members are in Supplementary Material S2. We are grateful to the numerous people at study sites, in both research and clinical roles, who contributed to this study. We are also grateful to all of the patients who consented to participation. Trial registration: ISRCTN14284759. Funding Information: This project (project 13/94/10) is funded by the Efficacy and Mechanism Evaluation Programme , a Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership. The views expressed in this publication are those of the authors and not necessarily those of the MRC, NIHR, or the Department of Health and Social Care. High-pressure, drug-coated, and control balloons were supplied by CR Bard (Becton Dickinson and Company), which had no other role in the study. EJR received salary support from the NIHR Biomedical Research Centre , based at Guy's and St Thomas' NHS Foundation Trust and King's College London . We are grateful to Vikki Semik, Charlotte Bailey, and Micheala Curran for work on trial management; Konstantinos Katsanos for work in planning the study; and members of the data monitoring and trial steering committees. These committee members were Duncan Ettles, Richard Haynes, Thomas Hiemstra, Peter Littler, Andrew McGrath, Sandip Mitra, David Oliviera, Nick Palmer, Uday Patel, Isabel Reading, Max Troxler, Christopher Watson, and Andrew Wigham. Further details on committee members are in Supplementary Material S2 . We are grateful to the numerous people at study sites, in both research and clinical roles, who contributed to this study. We are also grateful to all of the patients who consented to participation. Publisher Copyright: {\textcopyright} 2021 International Society of Nephrology Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",
year = "2021",
month = aug,
doi = "10.1016/j.kint.2021.02.040",
language = "English",
volume = "100",
pages = "447--456",
journal = "Kidney International",
issn = "0085-2538",
publisher = "Nature Publishing Group",
number = "2",
}