Randomized clinical trial comparing decellularized bovine ureter with expanded polytetrafluoroethylene for vascular access

Abstract

Background: The SynerGraft model 100 (SG 100) is a decellularized bovine uereter graft developed to improve on prosthetic conduits for vascular access. Its clinical performance was compared with polytetrafluoroethylene (ePTFE) in a prospective, pilot randomized study.

Methods: Patients requiring haemodialysis with no native vein options were included. Between June 2004 and June 2007, 29 patients received SG 100 and 27 ePTFE grafts. Forty-five patients had undergone previous access surgery. All grafts were between the brachial artery and the axillary vein.

Results: Clinical details were similar between the groups; overall mean(s.d.) follow-up was 469(398) days. After 1 year, there were no significant differences in primary patency (28 per cent for SG 100 versus 48 per cent for ePTFE; P = 0.290), assisted primary patency (52 versus 64 per cent; P = 0.430) or secondary patency (57 versus 68 per cent; P = 0.370). Freedom from infection at 1 year was 96 per cent for SG 100 and 91 per cent for ePTFE (P = 0.410). Fifty-seven further procedures (18 endovascular and 39 surgical) were needed to maintain patency in 50 grafts (23 SG 100 and 27 ePTFE).

Conclusion: Both grafts were adequate conduits for haemodialysis and were amenable to repair. Anticipated advantages for SG 100 were not seen in either patency or stability.