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Efficacy of Paclitaxel Balloon for Hemodialysis Stenosis Fistulae After One Year Compared to High-Pressure Balloons: A Controlled, Multicenter, Randomized Trial

  • T. Moreno-SánchezEmail author
  • M. Moreno-Ramírez
  • F. H. Machancoses
  • P. Pardo-Moreno
  • P. F. Navarro-Vergara
  • J. García-Revillo
Clinical Investigation Venous Interventions
Part of the following topical collections:
  1. Venous Interventions

Abstract

Purpose

A controlled, prospective, multicenter, randomized trial to compare primary patency after angioplasty with a drug-coated balloon versus plain angioplasty balloon in stenosis of dysfunctional fistulae and grafts for hemodialysis.

Materials and Methods

A total of 136 patients (148 angioplasties) at four centers were randomized to receive a drug-coated balloon or plain angioplasty balloon after satisfactory angioplasty with a high-pressure balloon. The inclusion criteria were clinical signs of vascular dysfunction confirmed by Doppler Ultrasound and/or angiography. The primary endpoint was target lesion patency defined as time elapsed between the completion of effective and the appearance of restenosis at 6 and 12 months after angioplasty. Secondary endpoints included the relationship between the location of the stenosis, previous angioplasty, demographic variables and survival.

Results

Primary patency after angioplasty was higher in the group treated with the drug-coated balloon than the plain angioplasty balloon (153.01 to 141.69 days at 6 months; 265.78 to 237.83 days at 12 months). Drug-coated balloon angioplasty resulted in superior patency after 6 and 12 months, but this result was not statically significant (P = 0.068 at 6 months; P = 0.369 at 12 months). There was no relation between target lesion patency and the other variables studied. Overall mortality in the plain angioplasty balloon group was higher (9% vs. 5.7%) but not statistically significant.

Conclusions

Drug-coated balloon angioplasty resulted in superior survival of dysfunctional peripheral vascular access at 6 and 12 months, but this result was not statistically significant. Both arms show equivalent complications and similar mortality.

Level of Evidence

Level Ia, therapeutic study, RCT. EBM ratings will be based on a scale of 1-5.

Keywords

Paclitaxel Drug-eluting balloon Angioplasty High-pressure balloon Hemodialysis Arteriovenous fistula Primary patency 

Notes

Acknowledgements

Authors wish to thank the nephrologists Benitez M, Calurano R, Sánchez M, Martínez A and Torres MJ, the help in the follow-up of the patients participating in the study and the Regional Institute for Health and Clinical Research in Andalusia (Spain) for their support in the coordination and monitoring of this study.

Author Contributions

Study conception and design were performed by TM-S and MM-R. Material preparation and data collection were performed by TM-S, MM-R, PP, PN and JG-R. Statistical analysis and results were performed by FHM. The first draft of the manuscript was written by TM-S and MM-R, and all authors commented on all versions of the manuscript. All authors read and approved the final manuscript.

Funding

“This study was funded by a grant from Biotronik SE & Co. KG, Berlin, Germany to the value of 14,838 € (Grant Number “Ref.2015 CEM BIOTRONIK S.A./FABIS 01”).” This Grant was donated to Fabis, the Foundation for Health Investigation in the Province of Huelva. Fabis is the manager and the administrator of the grant.

Compliance with Ethical Standards

Conflict of interest

The first author has received inscription to two courses: by Abbot (CLIC 2019) and by COOK (venous interventional course in 2018). The second author has received a grant by Bard to attend CIRSE 2018. The fourth author has received a speaker honorarium from Penumbra and from Boston Scientific in the last year

Ethical Approval

The trial took place in accordance with recommendations for clinical trials and product assessment in the research phase in the humans, which appears in The Declaration of Helsinki and revised at successive world assemblies (WMA, 2013) and current Spanish legislation on clinical trials (RD 223/2004). ICH-GCP (CPMP/ICH/135/95) rules were adhered to the CEIC (Ethical Committees) of the four hospitals, and the Regional Institute for Health and Clinical Research in Andalusia, Spain (RIHCRA), reviewed and approved the protocol and the signed consent form before recruiting began. Before carrying out any specific procedure in the protocol, the participant signed and dated the informed consent form approved by the CEIC. Monitoring and promotion were carried out by the RIHCRA as well as the coordination of the four centers. Consent for publication was obtained for every individual person’s data included in the study.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2019

Authors and Affiliations

  1. 1.UGC Diagnóstico por la Imagen, Radiology DepartmentHospital Universitario Juan Ramón JiménezHuelvaSpain
  2. 2.UGC NefrologíaHospital Universitario Juan Ramón JiménezHuelvaSpain
  3. 3.Fundación Andaluza Beturia para la Investigación en Salud (FABIS)Hospital Universitario Juan Ramón JiménezHuelvaSpain
  4. 4.UGC Diagnóstico por la ImagenHospital Universitario Virgen de las NievesGranadaSpain
  5. 5.UGC Diagnóstico por la ImagenHospital Universitario Puerto RealCádizSpain
  6. 6.UGC Diagnóstico por la ImagenHospital Universitario Reina SofíaCórdobaSpain

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