A randomized trial of vonapanitase (PATENCY-1) to promote radiocephalic fistula patency and use for hemodialysis.

Abstract

OBJECTIVE:

Arteriovenous fistulas created in patients with chronic kidney disease often lose patency and fail to become usable. This prospective trial evaluated the efficacy of vonapanitase, a recombinant human elastase, in promoting radiocephalic fistula patency and use for hemodialysis.

METHODS:

PATENCY-1 was a double-blind, placebo-controlled trial that enrolled 349 patients on or approaching hemodialysis and being evaluated for radiocephalic arteriovenous fistula creation. Of these, 313 were randomized and 311 treated. Patients were assigned to vonapanitase (n = 210) or placebo (n = 103). The study drug solution was applied topically to the artery and vein for 10 minutes immediately after fistula creation. The primary and secondary end points were primary patency (time to first thrombosis or corrective procedure) and secondary patency (time to abandonment). Tertiary end points included use of the fistula for hemodialysis, fistula maturation by ultrasound, and procedure rates.

RESULTS:

The Kaplan-Meier estimates of 12-month primary patency were 42% (95% confidence interval [CI], 35-49) and 31% (95% CI, 21-42) for vonapanitase and placebo (P = .25). The Kaplan-Meier estimates of 12-month secondary patency were 74% (95% CI, 68-80) and 61% (95% CI, 51-71) for vonapanitase and placebo (P = .048). The proportions of vonapanitase and placebo patients were 39% and 25% (P = .035) with unassisted use for hemodialysis and 64% and 44% (P = .006) with unassisted plus assisted use.

CONCLUSIONS:

Vonapanitase treatment did not significantly improve primary patency but was associated with increased secondary patency and use for hemodialysis. Further research is needed to evaluate these end points.

• Authors: Anthony J Bleyer, Vincent A Scavo, Samuel E Wilson, Barry J Browne, Brian L Ferris, C Keith Ozaki, Timmy Lee, Eric K Peden, Bradley S Dixon, Rick Mishler, Timothy P O'Connor, Kendrah Kidd, Steven K Burke, PATENCY-1 Investigators
• Journal: Journal of vascular surgery (J Vasc Surg) Vol. 69 Issue 2 Pg. 507-515 (02 2019) ISSN: 1097-6809 [Electronic] United States
• PMID: 30683197 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Chemical References

• Carrier Proteins
• Pancreatic Elastase
• cholesterol-binding protein

Topics

• Administration, Topical
• Adult
• Aged
• Arteriovenous Shunt, Surgical (adverse effects)
• Carrier Proteins (administration & dosage, adverse effects)
• Double-Blind Method
• Female
• Graft Occlusion, Vascular (etiology, physiopathology, prevention & control)
• Humans
• Male
• Middle Aged
• Pancreatic Elastase (administration & dosage, adverse effects)
• Prospective Studies
• Radial Artery (diagnostic imaging, physiopathology, surgery)
• Renal Dialysis
• Thrombosis (etiology, physiopathology, prevention & control)
• Time Factors
• Treatment Outcome
• United States
• Upper Extremity (blood supply)
• Vascular Patency (drug effects)
• Veins (diagnostic imaging, physiopathology, surgery)