Winner of the ESVS Prize 1991. European Prospective Randomised Multi-centre Axillo-bifemoral Trial.
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.
Wittens
C H
CH
Department of General Surgery, University Hospital, Dijkzigt, Rotterdam, The Netherlands.
van Houtte
H J
HJ
van Urk
H
H
D000368:Aged; D000369:Aged, 80 and over; D000714:Anastomosis, Surgical / Q000379:methods; D001157:Arterial Occlusive Diseases / Q000503:physiopathology / Q000601:surgery*; D001366:Axillary Artery / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D005060:Europe; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology / Q000628:therapy; D011446:Prospective Studies; D012307:Risk Factors; D015996:Survival Rate; D014654:Vascular Patency