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A multicenter randomized controlled trial indicates that paclitaxel-coated balloons provide no benefit for arteriovenous fistulas.
Karunanithy, Narayan; Robinson, Emily J; Ahmad, Farhan; Burton, James O; Calder, Francis; Coles, Simon; Das, Neelanjan; Dorling, Anthony; Forman, Colin; Jaffer, Ounali; Lawman, Sarah; Lakshminarayan, Raghuram; Lewlellyn, Rhys; Peacock, Janet L; Ramnarine, Raymond; Mesa, Irene Rebollo; Shaikh, Shoaib; Simpson, James; Steiner, Kate; Suckling, Rebecca; Szabo, Laszlo; Turner, Douglas; Wadoodi, Ashar; Wang, Yanzhong; Weir, Graeme; Wilkins, C Jason; Gardner, Leanne M; Robson, Michael G.
Afiliación
  • Karunanithy N; Department of Interventional Radiology, Guy's and St Thomas' NHS Foundation Trust, London, UK.
  • Robinson EJ; Faculty of Life Sciences and Medicine, King's College London, London, UK.
  • Ahmad F; Department of Radiology, Royal Berkshire NHS Foundation Trust, Reading, UK.
  • Burton JO; Department of Cardiovascular Sciences, University of Leicester, Leciester, UK; Department of Renal Medicine, University Hospitals of Leicester NHS Trust, Leicester, UK.
  • Calder F; Department of Nephrology and Transplantation, Guy's and St Thomas' NHS Foundation Trust, London, UK.
  • Coles S; Department of Radiology, Portsmouth Hospitals NHS Trust, Portsmouth, UK.
  • Das N; Department of Nephrology, East Kent Hospitals NHS Foundation Trust, Canterbury, UK.
  • Dorling A; Faculty of Life Sciences and Medicine, King's College London, London, UK; Department of Nephrology and Transplantation, Guy's and St Thomas' NHS Foundation Trust, London, UK.
  • Forman C; Department of Nephrology and Transplantation, Royal Free London NHS Foundation Trust, London, UK.
  • Jaffer O; Department of Radiology, Barts Health NHS Trust, London, UK.
  • Lawman S; Department of Nephrology, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.
  • Lakshminarayan R; Department of Radiology, Hull University Teaching Hospitals NHS Trust, Hull, UK.
  • Lewlellyn R; Department of Radiology, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.
  • Peacock JL; Faculty of Life Sciences and Medicine, King's College London, London, UK; Department of Epidemiology, Dartmouth College, Hanover, New Hampshire, USA.
  • Ramnarine R; Department of Radiology, Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK.
  • Mesa IR; Faculty of Life Sciences and Medicine, King's College London, London, UK.
  • Shaikh S; Department of Radiology, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.
  • Simpson J; Department of Radiology, Lancashire Teaching Hospitals NHS Trust, Preston, UK.
  • Steiner K; Department of Radiology, East and North Hertfordshire NHS Trust, Stevenage, UK.
  • Suckling R; Department of Nephrology, Epsom and St Helier University Hospitals NHS Trust, Carshalton, UK.
  • Szabo L; Department of Nephrology and Transplantation, Cardiff and Vale University Health Board, Cardiff, UK.
  • Turner D; Department of Radiology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
  • Wadoodi A; Department of Nephrology and Transplantation, St George's Healthcare NHS Trust, London, UK.
  • Wang Y; Faculty of Life Sciences and Medicine, King's College London, London, UK.
  • Weir G; Department of Radiology, Lothian NHS, Edinburgh, UK.
  • Wilkins CJ; Department of Nephrology and Transplantation, Guy's and St Thomas' NHS Foundation Trust, London, UK; Department of Radiology, King's College Hospital NHS Foundation Trust, London, UK.
  • Gardner LM; Faculty of Life Sciences and Medicine, King's College London, London, UK.
  • Robson MG; Faculty of Life Sciences and Medicine, King's College London, London, UK; Department of Nephrology and Transplantation, Guy's and St Thomas' NHS Foundation Trust, London, UK. Electronic address: Michael.robson@kcl.ac.uk.
Kidney Int ; 100(2): 447-456, 2021 08.
Article en En | MEDLINE | ID: mdl-33781793
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Derivación Arteriovenosa Quirúrgica / Fármacos Cardiovasculares / Fístula Arteriovenosa / Angioplastia de Balón Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Kidney Int Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Derivación Arteriovenosa Quirúrgica / Fármacos Cardiovasculares / Fístula Arteriovenosa / Angioplastia de Balón Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Kidney Int Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos