Comparison of carbon-impregnated and standard ePTFE prostheses in extra-anatomical anterior tibial artery bypass: a prospective randomized multicenter study

European Journal of Vascular and Endovascular Surgery : the Official Journal of the European Society for Vascular Surgery
X KapferF-M Groegler

Abstract

The aim of this study was to find out whether carbon impregnated ePTFE vascular grafts have better long-term patency or limb salvage rates than Standard ePTFE vascular grafts in crural revascularization in patients with chronic critical ischemia. Prospective randomized multicenter trial. Study endpoints were 36 months follow-up, major amputation or death. We used 6mm carbon ePTFE (Carboflo) and 6mm standard ePTFE vascular grafts (both C.R. BARD Inc./IMPRA). From June 1995 to November 1998, 283 patients were randomly assigned either to carbon (C) (n=140) or to standard (St) ePTFE (n=143) vascular grafts at 19 centres. A standard protocol was used with lateral extra-anatomic course of the graft to the anterior tibial artery and of a distal vein patch or cuff. More than 90% of the patients had rest pain or gangrene. Two hundred and sixty-five (C=130; St=135) patients could be analysed in the intention-to-treat (ITT) group. Primary patency, secondary patency and limb salvage rates after 36 months were 33, 43 and 67% in the carbon- and 30, 38 and 58% in the standard PTFE group, respectively, (log-rank test: p=0.20, 0.12 and 0.16). Additional analyses were made per protocol (PP) and as-treated (AT). The retrospective power of the stu...Continue Reading

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