Arteriovenous fistula patency in the 3 years following vonapanitase and placebo treatment
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Authors
Peden, Eric K.O'Connor, Timothy P.
Browne, Barry J.
Dixon, Bradley S.
Schanzer, Andres
Jensik, Stephen C.
Sam, Albert D. 2nd
Burke, Steven K.
UMass Chan Affiliations
Department of Surgery, Division of Vascular and Endovascular SurgeryDocument Type
Journal ArticlePublication Date
2017-04-01
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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.Source
J Vasc Surg. 2017 Apr;65(4):1113-1120. Epub 2016 Dec 13. Link to article on publisher's siteDOI
10.1016/j.jvs.2016.08.101Permanent Link to this Item
http://hdl.handle.net/20.500.14038/40212PubMed ID
27986480Related Resources
Link to Article in PubMedRights
Copyright 2016 The Authors. Published by Elsevier Inc. on behalf of the Society for Vascular Surgery.Distribution License
http://creativecommons.org/licenses/by-nc-nd/4.0/ae974a485f413a2113503eed53cd6c53
10.1016/j.jvs.2016.08.101
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Except where otherwise noted, this item's license is described as Copyright 2016 The Authors. Published by Elsevier Inc. on behalf of the
Society for Vascular Surgery.