RESUMO
OBJECTIVES: 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. DESIGN: Prospective randomized multicenter trial. Study endpoints were 36 months follow-up, major amputation or death. MATERIALS: We used 6mm carbon ePTFE (Carboflo) and 6mm standard ePTFE vascular grafts (both C.R. BARD Inc./IMPRA). METHODS: 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. RESULTS: 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 study was calculated as 79 and 83%. CONCLUSION: The ITT, PP and AT analysis, showed no statistically significant advantage of the carbon ePTFE vascular graft in terms of patency or limb salvage over the standard ePTFE vascular graft at 36 months.