Objective: Prosthetic grafts continue to be required for hemodialysis access when the options for native fistulas have been exhausted. The inferior long-term patency of grafts makes the possibility of preventing occlusion with heparin-bonded grafts an attractive alternative. We carried out a prospective randomized study to compare the patency of standard grafts with heparin-bonded grafts.
Methods: Patients with end-stage renal failure requiring a prosthetic access were randomized to receive either a standard expanded polytetrafluorethylene (ePTFE) graft or a heparin-bonded ePTFE graft. Patients were enrolled from June 2007 until November 2011 and were followed up until July 2013, when the study concluded.
Results: In this study, 160 patients were randomized and followed up for a median of 23.5 months. No patient was lost to follow-up. Primary patency was 35% and 14% for heparin-bonded grafts and 29% and 12% for standard ePTFE grafts at 6 and 12 months, respectively (P = .48). Assisted primary patency was 54%, 41%, and 27% for heparin-bonded grafts and 41%, 30%, and 23% for standard grafts at 12, 24, and 36 months, respectively (P = .12). Secondary patency was 83%, 83%, and 81% for heparin-bonded grafts and 81%, 73%, and 68% for standard grafts at 12, 24, and 36 months, respectively (P = .33). There were significantly fewer thromboses in heparin-bonded grafts during the first 5 months (P = .020). Of 80 standard grafts, 24 were eventually abandoned vs 17 heparin-bonded grafts (P = .188). Bleeding complications, infections, and intervention rates were similar in both groups.
Conclusions: Heparin-bonded grafts demonstrated a trend to improved patency, but the difference was not statistically significant. Heparin-bonded grafts had a significantly lower early thrombosis rate that was sustained only for the first 5 months of follow-up.
Trial registration: ClinicalTrials.gov NCT00737620.
Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.