Fluoropolymer-coated Dacron Versus PTFE Grafts for Femorofemoral Crossover Bypass: Randomised Trial

Objectives

To investigate whether patency of a thin walled 8mm fluoropassivated Dacron graft was similar to that of a standard 8mm PTFE graft for femorofemoral crossover bypass surgery.

Design

A randomised multicentre clinical trial comparing two vascular grafts with participation of 10 departments of vascular surgery in Denmark, Sweden and Norway.

Patients and methods

198 patients were randomised to PTFE (n=107) or fluoropolymer-coated Dacron grafts (n=91), 63% underwent surgery for claudication, 27% for ischaemic rest pain and 10% for tissue loss. The median follow-up time was 24 months (IQR 19–26 months).

Results

The primary patency rate of the two grafts was similar (log rank test: p=0.35). The primary patency rates (95% CI) for coated Dacron and PTFE grafts were 92% (86–98) and 94% (89–99) at 12 months and 87% (74–95) and 93% (87–99) at 24 months, respectively.

Conclusion

In patients with unilateral iliac artery disease not amenable to angioplasty, the femoral-femoral bypass is durable and effective. No difference in patency was found between the two graft materials (fluoropolymer coated Dacron and PTFE).

Keywords: Femorofemoral bypass, Patency, Fluoropassivated Dacron, PTFE