BACKGROUND: In this prospective randomized multicenter trial, knitted gelatine-coated Dacron, knitted collagen-coated Dacron, and stretch polytetrafluoroethylene (PTFE) aortic bifurcation grafts were compared for their long-term results. METHODS:Between 1991 and 1998, 149 patients undergoing elective revascularization for aortoiliac occlusive disease were prospectively randomized at 3 tertiary referral centers of vascular surgery. The patients received either gelatine-coated Dacron (GEL-D) grafts (n = 52), collagen-coated Dacron (COL-D) grafts (n = 49), or stretch PTFE grafts (n = 48). RESULTS: No intraoperative deaths were recorded. The 30-day mortality was 4%. The mean follow-up time was 97 months. Primary patency rates were 77% for GEL-D, 78% for COL-D, and 79% for PTFE at 8 years. The differences were not different (P >.8). Secondary corrected 8-year patency rates were also not significantly different (P >.5): 91% for GEL-D, 96% for COL-Dm and 90% for PTFE. Five Dacron and 1 PTFE grafts were affected by infections. CONCLUSIONS: Bifurcation grafts for revascularization of aortoiliac occlusive disease using these 3 materials were comparable in terms of primary and secondary patency and long-term complication rates.
RCT Entities:
BACKGROUND: In this prospective randomized multicenter trial, knitted gelatine-coated Dacron, knitted collagen-coated Dacron, and stretch polytetrafluoroethylene (PTFE) aortic bifurcation grafts were compared for their long-term results. METHODS: Between 1991 and 1998, 149 patients undergoing elective revascularization for aortoiliac occlusive disease were prospectively randomized at 3 tertiary referral centers of vascular surgery. The patients received either gelatine-coated Dacron (GEL-D) grafts (n = 52), collagen-coated Dacron (COL-D) grafts (n = 49), or stretch PTFE grafts (n = 48). RESULTS: No intraoperative deaths were recorded. The 30-day mortality was 4%. The mean follow-up time was 97 months. Primary patency rates were 77% for GEL-D, 78% for COL-D, and 79% for PTFE at 8 years. The differences were not different (P >.8). Secondary corrected 8-year patency rates were also not significantly different (P >.5): 91% for GEL-D, 96% for COL-Dm and 90% for PTFE. Five Dacron and 1 PTFE grafts were affected by infections. CONCLUSIONS: Bifurcation grafts for revascularization of aortoiliac occlusive disease using these 3 materials were comparable in terms of primary and secondary patency and long-term complication rates.
Authors: Stephanie Roll; Jacqueline Müller-Nordhorn; Thomas Keil; Hans Scholz; Daniela Eidt; Wolfgang Greiner; Stefan N Willich Journal: BMC Surg Date: 2008-12-19 Impact factor: 2.102
Authors: Sandra Spronk; Johanna L Bosch; Constance Ryjewski; Judith Rosenblum; Guido C Kaandorp; John V White; M G Myriam Hunink Journal: PLoS One Date: 2008-12-09 Impact factor: 3.240