Superior two-year results of externally unsupported polyester compared to supported grafts in above-knee bypass grafting: a multicenter randomised trial.

OBJECTIVES The aim of this study was to compare externally supported thin wall knitted polyester (P-EXS) and externally unsupported thin wall knitted polyester (P-non-EXS) for above-knee (AK) femoro-popliteal bypass grafting. DESIGN A prospective multicenter randomised clinical trial. MATERIAL AND METHODS Between 1999 and 2008, 265 AK femoro-popliteal bypass grafts (6 mm in diameter) were performed, including 136 P-EXS and 129 P-non-EXS. The selection of patients was based on the presence of disabling claudication or critical ischaemia. Follow-up took place at 3, 6, 12, 18, and 24 months and included clinical examination and duplex ultrasonography. The main end points of this study were primary patency rates at one and two years. Secondary end points were mortality, and primary assisted and secondary patency rates. Cumulative patency rates were calculated with life-table analysis and log-rank testing. RESULTS The 1-year primary, primary assisted and secondary patency rates were 65%, 70% and 84%, respectively, for P-EXS and 76% (p = 0.05), 82% (p = 0.03) and 88% (p = 0.35), respectively, for P-non-EXS. Two-year primary, primary assisted and secondary patency rates were 45%, 57% and 70%, respectively, for P-EXS and 62% (p = 0.003), 75% (p = 0.005) and 84% (p = 0.02), respectively, for P-non-EXS. The overall mortality rate after two years was 11.3%. CONCLUSION In above-knee femoro-popliteal bypass grafting patency rates of externally supported knitted polyester grafts were inferior to their unsupported counterpart. ISRCTN: At the time this study started this number was not the standard.