Dacron or ePTFE for femoro-popliteal above-knee bypass grafting: short- and long-term results of a multicentre randomised trial.

OBJECTIVES

To compare expanded polytetrafluoroethylene (ePTFE) prosthesis and collagen-impregnated knitted polyester (Dacron) for above-knee (AK) femoro-popliteal bypass grafts.

DESIGN

A prospective multicentre randomised clinical trial.

PATIENTS AND METHODS

Between 1992 and 1996, 228 AK femoro-popliteal bypass grafts were randomly allocated to either an ePTFE (n=114) or a Dacron (n=114) vascular graft (6mm in diameter). Patients were eligible for inclusion if presenting with disabling claudication, rest pain or tissue loss. Follow-up was performed and included clinical examination and duplex ultrasonography at all scheduled intervals. All patients were treated with warfarin. The main end-point of this study was primary patency of the bypass graft at 2, 5 and 10 years after implantation. Secondary end-points were mortality, primary assisted patency and secondary patency. Cumulative patency rates were calculated with life-table analysis and with log-rank test.

RESULTS

After 5 years, the primary, primary assisted and secondary patency rates were 36% (confidence interval (CI): 26-46%), 46% (CI: 36-56%) and 51% (CI: 41-61%) for ePTFE and 52% (CI: 42-62%) (p=0.04), 66% (CI: 56-76%) (p=0.01) and 70% (CI: 60-80%) (p=0.01) for Dacron, respectively. After ten years these rates were respectively 28% (CI:18-38%), 31% (CI:19-43%) and 35% (CI: 23-47%) for ePTFE and 28% (CI: 18-38%), 49% (CI: 37-61%) and 49% (CI: 37-61%) for Dacron.

CONCLUSION

During prolonged follow-up (10 years), Dacron femoro-popliteal bypass grafts have superior patency compared to those of ePTFE grafts. Dacron is the graft material of choice if the saphenous vein is not available.