European prospective randomised multi-centre axillo-bifemoral trial

Abstract

In vitro and in vivo studies revealed significantly better haemodynamic properties for a newly designed axillo-bifemoral bypass graft, with a flowsplitter at the bifurcation. In order to analyse the clinical relevance of these improved haemodynamic properties a prospective randomised clinical trial was performed. The patency rates of two different axillo-bifemoral bypass grafts, differing only in the configuration of the bifurcation: one with a contralateral branch at an angle of 90 degrees and one with a flowsplitter, were analysed. In 19 centres, 117 patients were randomised, 59 receiving a prosthesis with a flowsplitter, and 58 a prosthesis with a 90 degrees bifurcation. Indications and risk factors were equally distributed in both groups. Final analysis after 3 years with a mean follow-up of 12 months (range 3-36 months) showed that the prosthesis with a flowsplitter had a significantly better patency rate after 2 years of 84% compared to the patency rate of the prosthesis with a 90 degrees-angled bifurcation of 38% (log-rank test, p less than 0.0001). These data were not significantly influenced by the indication for the operation, associated risk factors (e.g. diabetes mellitus, hypertension or myocardial infarction), outflow tract or anti-coagulant therapy. Other endpoints such as death and graft infection did not differ significantly.