A prospective randomized study of heparin-bonded graft (Propaten) versus standard graft in prosthetic arteriovenous access

Abstract

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. 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. 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. 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.