UMMS Affiliation

Department of Surgery, Division of Vascular and Endovascular Surgery

Publication Date

4-1-2017

Document Type

Article

Disciplines

Cardiovascular Diseases | Circulatory and Respiratory Physiology | Surgery

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

Journal/Book/Conference Title

Journal of vascular surgery

PubMed ID

27986480

Creative Commons License

Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.

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