A comparison between PTFE and denatured homologous vein grafts for haemodialysis access: a prospective randomised multicentre trial. The SMASH Study Group. Study of Graft Materials in Access for Haemodialysis.

OBJECTIVES

To compare patency and complication rates of polytetrafluoroethylene (PTFE) grafts and denatured homologous vein (DHV) grafts for long-term haemodialysis.

DESIGN

A prospective randomised multicentre trial.

MATERIALS

One hundred and thirty-one patients were enrolled between September 1994 and April 1997. Sixty-three DHV grafts and 68 PTFE grafts were implanted in 60 meals and 71 females. Complications and interventions were monitored. Patency rates, complication rates, and intervention rates of PTFE and DHV were compared.

RESULTS

The mean follow-up was 313 days for DHV (range 1-771) and 339 (3-909) days for PTFE. The total follow-up was 54.1 patient-years for DHV and 63.1 for PTFE. The 1-year primary patency rates were 30% and 40% for DHV and PTFE respectively. Secondary patency rate was 63% for both DHV and PTFE. Most frequent complication was thrombosis. A total of 75 thrombotic events (1.39 per patient-year) occurred in 35 (56%) DHV grafts and 78 (1.24 per py) in 36 (53%) PTFE grafts. A total of nine infections were seen in nine (14%) DHV grafts, whereas 21 infections in 20 (29%) PTFE grafts were seen (p = 0.08). All but one infected DHV graft could be salvaged with systemic antibiotics. In contrast, surgical intervention was necessary in nine PTFE grafts (p = 0.02). For aneurysms, eight DHV and two PTFE grafts needed revision (p = 0.03).

CONCLUSION

Patency rates between DHV and PTFE were not different. More infections were seen in PTFE grafts, and significantly more PTFE grafts needed surgical revision or removal because of infection. Significantly more DHV grafts were surgically revised or removed because of aneurysms.