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Arteriovenous fistula patency in the 3 years following vonapanitase and placebo treatment
Open Access Articles
  • Eric K. Peden, Houston Methodist Hospital
  • Timothy P. O'Connor, Renal Care Associates
  • Barry J. Browne, California Institute of Renal Research
  • Bradley S. Dixon, University of Iowa Hospital and Clinics
  • Andres Schanzer, University of Massachusetts Medical School
  • Stephen C. Jensik, Rush University Medical Center
  • Albert D. Sam, 2nd, Tulane University Heart and Vascular Institute
  • Steven K. Burke, Proteon Therapeutics
UMMS Affiliation
Department of Surgery, Division of Vascular and Endovascular Surgery
Date
4-1-2017
Document Type
Article
Abstract

OBJECTIVE: This study explored the long-term outcomes of arteriovenous fistulas treated with vonapanitase (recombinant human elastase) at the time of surgical creation.

METHODS: This was a randomized, double-blind, placebo-controlled trial of 151 patients undergoing radiocephalic or brachiocephalic arteriovenous fistula creation who were randomized equally to placebo, vonapanitase 10 mug, or vonapanitase 30 mug. The results after 1 year of follow-up were previously reported. The current analysis occurred when the last patient treated was observed for 3 years. For the current analysis, the primary end point was primary patency; the secondary end points included secondary patency, use of the fistula for hemodialysis, and rate of procedures to restore or to maintain patency.

RESULTS: There was no significant difference in the risk of primary patency loss with vonapanitase 10 mug or 30 mug vs placebo. When seven initial patency loss events related to cephalic arch and central vein balloon angioplasty were excluded, the risk of patency loss was reduced with vonapanitase overall (hazard ratio [HR], 0.63; P = .049) and 30 mug (HR, 0.51; P = .03). In patients with radiocephalic fistulas (n = 67), the risks of primary and secondary patency loss were reduced with 30 mug (HR, 0.37 [P = .02] and 0.24 [P = .046], respectively). The rate of procedures to restore or to maintain fistula patency was reduced with 30 mug vs placebo (0.23 vs 0.72 procedure days/patient/year; P = .03) and also reduced in patients with radiocephalic fistulas with 30 mug vs placebo (0.17 vs 0.85 procedure days/patient/year; P = .048).

CONCLUSIONS: In this study, vonapanitase did not significantly improve primary patency in the primary analysis but did significantly improve primary patency in an analysis that excluded patency loss due to cephalic arch and central vein balloon angioplasty. In patients with radiocephalic fistulas, 30 mug significantly improved primary and secondary patency. Vonapanitase 30 mug decreased the rate of procedures to restore or to maintain patency in the analysis that included all patients and in the subset with radiocephalic fistulas.

Rights and Permissions
Copyright 2016 The Authors. Published by Elsevier Inc. on behalf of the Society for Vascular Surgery. Citation: J Vasc Surg. 2017 Apr;65(4):1113-1120. Epub 2016 Dec 13. Link to article on publisher's site
DOI of Published Version
10.1016/j.jvs.2016.08.101
Related Resources
Link to Article in PubMed
PubMed ID
27986480
Creative Commons License
Creative Commons Attribution-Noncommercial-No Derivative Works 4.0
Citation Information
Eric K. Peden, Timothy P. O'Connor, Barry J. Browne, Bradley S. Dixon, et al.. "Arteriovenous fistula patency in the 3 years following vonapanitase and placebo treatment" Vol. 65 Iss. 4 (2017) ISSN: 0741-5214 (Linking)
Available at: http://works.bepress.com/andres_schanzer/112/