OBJECTIVE: This report presents the results of a prospective randomized study that compared 2 grafts of different diameter: 6 mm, and 8 mm tapered to 6 mm at the arterial site, placed in the upper arm for hemodialysis in a selected population of patients younger than 71 years without diabetes. METHODS:Seventy consecutive patients younger than 71 years without diabetes who required an upper arm graft between January 1997 and January 2002 and without previous access in the same limb were randomly allocated to receive either a 6-mm graft or 6- to 8-mm graft. Graft flow was measured every 3 months with the Doppler dilution technique. When access flow was less than 600 mL/min, fistulography was performed, and any stenosis was surgically treated with venous outflow replacement. Thrombectomy and associated stenosis treatment in the same stage was performed in all cases immediately after detection of thrombosis. Complication rate, and primary, assisted primary, and secondary patency rates were compared between the two groups with the Student t test and life table analysis. RESULTS:Mean access flow was 975 mL/min for 6-mm grafts (range, 600-1500 mL/min; 95% confidence interval [CI], 889-1070), and for 6- to 8-mm grafts was 1397 mL/min (range, 1122-2700 mL/min; 95% CI, 1122-1672). This difference was significant (P <.01). Complication rate was 0.45 episodes per graft-year in 6-mm grafts, and 0.19 episodes per graft-year in 6- to 8-mm grafts (P <.01). At 1, 2, and 3 years, primary patency rates were 62%, 58%, and 44%, respectively, for 6-mm grafts, and 85%, 78%, and 73% for 6- to 8-mm grafts; log-rank comparison between curves was P =.0259. At 1, 2, and 3 years, secondary patency rates were 85%, 85%, and 85%, respectively, for 6-mm grafts, and 90%, 90%, and 90% for 6- to 8-mm grafts; log-rank comparison between curves was not significant, at P =.0603. At 1, 2, and 3 years, assisted primary patency rates were 84%, 79%, and 76%, respectively, for 6-mm grafts, and 90% for 6- to 8-mm grafts; log-rank comparison was P =.0414. CONCLUSIONS: The results of this study show an advantage in terms of primary and assisted primary patency rates, and complication rate for upper arm grafts with diameter 6 mm to 8 mm over grafts with 6-mm diameter in a patient population younger than 70 years without diabetes. The finding of a similar secondary patency rate in both groups is probably due to the surveillance program with sequential measurement of access flow and prompt surgical treatment of stenosis. However, we needed twice the number of rescue procedures in 6-mm grafts to achieve a similar patency rate as with large-bore grafts. These study results must be carefully evaluated, taking into consideration the small number of patients and the selected patient population.
RCT Entities:
OBJECTIVE: This report presents the results of a prospective randomized study that compared 2 grafts of different diameter: 6 mm, and 8 mm tapered to 6 mm at the arterial site, placed in the upper arm for hemodialysis in a selected population of patients younger than 71 years without diabetes. METHODS: Seventy consecutive patients younger than 71 years without diabetes who required an upper arm graft between January 1997 and January 2002 and without previous access in the same limb were randomly allocated to receive either a 6-mm graft or 6- to 8-mm graft. Graft flow was measured every 3 months with the Doppler dilution technique. When access flow was less than 600 mL/min, fistulography was performed, and any stenosis was surgically treated with venous outflow replacement. Thrombectomy and associated stenosis treatment in the same stage was performed in all cases immediately after detection of thrombosis. Complication rate, and primary, assisted primary, and secondary patency rates were compared between the two groups with the Student t test and life table analysis. RESULTS: Mean access flow was 975 mL/min for 6-mm grafts (range, 600-1500 mL/min; 95% confidence interval [CI], 889-1070), and for 6- to 8-mm grafts was 1397 mL/min (range, 1122-2700 mL/min; 95% CI, 1122-1672). This difference was significant (P <.01). Complication rate was 0.45 episodes per graft-year in 6-mm grafts, and 0.19 episodes per graft-year in 6- to 8-mm grafts (P <.01). At 1, 2, and 3 years, primary patency rates were 62%, 58%, and 44%, respectively, for 6-mm grafts, and 85%, 78%, and 73% for 6- to 8-mm grafts; log-rank comparison between curves was P =.0259. At 1, 2, and 3 years, secondary patency rates were 85%, 85%, and 85%, respectively, for 6-mm grafts, and 90%, 90%, and 90% for 6- to 8-mm grafts; log-rank comparison between curves was not significant, at P =.0603. At 1, 2, and 3 years, assisted primary patency rates were 84%, 79%, and 76%, respectively, for 6-mm grafts, and 90% for 6- to 8-mm grafts; log-rank comparison was P =.0414. CONCLUSIONS: The results of this study show an advantage in terms of primary and assisted primary patency rates, and complication rate for upper arm grafts with diameter 6 mm to 8 mm over grafts with 6-mm diameter in a patient population younger than 70 years without diabetes. The finding of a similar secondary patency rate in both groups is probably due to the surveillance program with sequential measurement of access flow and prompt surgical treatment of stenosis. However, we needed twice the number of rescue procedures in 6-mm grafts to achieve a similar patency rate as with large-bore grafts. These study results must be carefully evaluated, taking into consideration the small number of patients and the selected patient population.
Authors: Gerald A Beathard; Charmaine E Lok; Marc H Glickman; Ahmed A Al-Jaishi; Donna Bednarski; David L Cull; Jeffery H Lawson; Timmy C Lee; Vandana D Niyyar; Donna Syracuse; Scott O Trerotola; Prabir Roy-Chaudhury; Surendra Shenoy; Margo Underwood; Haimanot Wasse; Karen Woo; Theodore H Yuo; Thomas S Huber Journal: Clin J Am Soc Nephrol Date: 2017-07-20 Impact factor: 8.237