PURPOSE:Polytetrafluoroethylene (PTFE) has long been used for hemodialysis access when there is no suitable superficial vein. We conducted a prospective randomized study to compare two PTFE grafts; the stretch Gore-tex graft and the Exxcel graft. METHODS: Between May 2000 and February 2001, PTFE grafts were implanted for hemodialysis access in the upper extremities of 94 consecutive patients with end-stage renal disease. Graft selection was randomized, with patients receiving either a Gore-tex or an Exxcel graft. All grafts were monitored for signs of thrombosis or other complications. Graft survival was analyzed using a life-table analysis and the log-rank test was applied to compare graft patency. RESULTS: The primary patency rates 1 and 2 years after implantation were 51% and 36% for the Exxcel grafts, and 71% and 45% for the Gore-tex grafts, respectively. The difference between the two groups was not significant at any time. The incidence of complications needing further surgical management was 8.2% in the Exxcel group and 6.7% in the Gore-tex group, without a significant difference. CONCLUSION:Exxcel grafts or Gore-tex stretch grafts can be used for dialysis access with similar expected outcomes for up to 2 years, despite the differences in their outer surface design. The yarn-wrapped design does not appear to enhance the graft patency and we found no remarkable difference.
RCT Entities:
PURPOSE:Polytetrafluoroethylene (PTFE) has long been used for hemodialysis access when there is no suitable superficial vein. We conducted a prospective randomized study to compare two PTFE grafts; the stretch Gore-tex graft and the Exxcel graft. METHODS: Between May 2000 and February 2001, PTFE grafts were implanted for hemodialysis access in the upper extremities of 94 consecutive patients with end-stage renal disease. Graft selection was randomized, with patients receiving either a Gore-tex or an Exxcel graft. All grafts were monitored for signs of thrombosis or other complications. Graft survival was analyzed using a life-table analysis and the log-rank test was applied to compare graft patency. RESULTS: The primary patency rates 1 and 2 years after implantation were 51% and 36% for the Exxcel grafts, and 71% and 45% for the Gore-tex grafts, respectively. The difference between the two groups was not significant at any time. The incidence of complications needing further surgical management was 8.2% in the Exxcel group and 6.7% in the Gore-tex group, without a significant difference. CONCLUSION: Exxcel grafts or Gore-tex stretch grafts can be used for dialysis access with similar expected outcomes for up to 2 years, despite the differences in their outer surface design. The yarn-wrapped design does not appear to enhance the graft patency and we found no remarkable difference.