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

Abstract

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.