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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN14284759 . Registered on 28 October 2015.
authors.affiliation: Department of Interventional Radiology, Guy's and St Thomas' NHS Trust, Guy's Hospital, Great Maze Pond, London, SE1 9RT, UK.
authors.forename: Narayan
authors.initials: N
authors.lastname: Karunanithy
authors.affiliation: Biostatistics Department, King's College London, London, SE5 8AF, UK.
authors.forename: Irene Rebollo
authors.initials: IR
authors.lastname: Mesa
authors.affiliation: MRC Centre for Transplantation, King's College London, Guy's Hospital, Great Maze Pond, London, SE1 9RT, UK.|Renal, Urology and Transplantation Directorate, Guy's and St Thomas' NHS Trust, Guy's Hospital, Great Maze Pond, London, SE1 9RT, UK.
authors.forename: Anthony
authors.initials: A
authors.lastname: Dorling
authors.affiliation: Renal, Urology and Transplantation Directorate, Guy's and St Thomas' NHS Trust, Guy's Hospital, Great Maze Pond, London, SE1 9RT, UK.
authors.forename: Francis
authors.initials: F
authors.lastname: Calder
authors.affiliation: Department of Interventional Radiology, Guy's and St Thomas' NHS Trust, Guy's Hospital, Great Maze Pond, London, SE1 9RT, UK.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Katsanos
authors.affiliation: MRC Centre for Transplantation, King's College London, Guy's Hospital, Great Maze Pond, London, SE1 9RT, UK.
authors.forename: Vikki
authors.initials: V
authors.lastname: Semik
authors.affiliation: Biostatistics Department, King's College London, London, SE5 8AF, UK.
authors.forename: Emily
authors.initials: E
authors.lastname: Robinson
authors.affiliation: Division of Health and Social Care Research, King's College London, Capital House, 42 Weston Street, London, SE1 3QD, UK.
authors.forename: Janet
authors.initials: J
authors.lastname: Peacock
authors.affiliation: Department of Interventional Radiology, East Kent Hospitals NHS Trust, Kent and Canterbury Hospital, Ethelbert Road, Canterbury, Kent, CT1 3NG, UK.
authors.forename: Neelanjan
authors.initials: N
authors.lastname: Das
authors.affiliation: Renal Services, Royal Free London NHS Trust, Pond Street, London, NW3 2QG, UK.
authors.forename: Colin
authors.initials: C
authors.lastname: Forman
authors.affiliation: Sussex Kidney Unit, Brighton and Sussex University Hospitals NHS Trust, Royal Sussex County Hospital, Eastern Road, Brighton, BN2 5BE, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Lawman
authors.affiliation: Department of Interventional Radiology, East and North Hertfordshire NHS Trust, Lister Hospital, Coreys Mill Lane, Stevenage, Herts, SG1 4AB, UK.
authors.forename: Kate
authors.initials: K
authors.lastname: Steiner
authors.affiliation: Department of Interventional Radiology, Kings' College Hospital NHS Trust, Denmark Hill, London, SE5 9RS, UK.
authors.forename: C Jason
authors.initials: CJ
authors.lastname: Wilkins
authors.affiliation: MRC Centre for Transplantation, King's College London, Guy's Hospital, Great Maze Pond, London, SE1 9RT, UK. michael.robson@kcl.ac.uk.|Renal, Urology and Transplantation Directorate, Guy's and St Thomas' NHS Trust, Guy's Hospital, Great Maze Pond, London, SE1 9RT, UK. michael.robson@kcl.ac.uk.
authors.forename: Michael G
authors.initials: MG
authors.lastname: Robson
mesh_terms: D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D001166:Arteriovenous Shunt, Surgical / Q000009:adverse effects*; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002985:Clinical Protocols; D020099:Coated Materials, Biocompatible; D004311:Double-Blind Method; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D006435:Renal Dialysis; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D062666:Vascular Access Devices; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
keywords: Angioplasty; Arteriovenous fistula; Balloon; Clinical trial; EME-funded; Efficacy; Fistuloplasty; Haemodialysis; Kidney; NIHR; Neointimal hyperplasia; Paclitaxel; Randomised controlled; Renal; Stenosis