Evaluation of 4-mm to 7-mm versus 6-mm prosthetic brachial-antecubital forearm loop access for hemodialysis: results of a randomized multicenter clinical trial

OBJECTIVE: Prosthetic arteriovenous fistulas for hemodialysis vascular access have a high incidence rate of thrombotic occlusions that result in graft failure. This randomized multicenter study was performed to assess the patency rates and the effect of 4-mm to 7-mm grafts on the development of stenoses.

METHODS: A total of 109 patients who needed vascular access for hemodialysis were randomized to receive either 6-mm (n = 57) or 4-mm to 7-mm prosthetic brachial-antecubital forearm loop accesses (polytetrafluoroethylene). Duplex scanning, with measurement of blood flow and peak systolic velocity and detection of stenoses (>50%), was performed at 1, 6, and 12 months after surgery. Clinical data were obtained in a prospective manner and primary, assisted primary, and secondary patency rates were calculated with the Kaplan-Meier life-table analysis. Statistical analysis was performed with the independent samples t test and chi(2) test.

RESULTS: At 1 year, patency rates were similar for both 4-mm to 7-mm and 6-mm prostheses (primary, 46% versus 43%; assisted primary, 62% versus 58%; secondary, 87% versus 91%). The incidence rate of thrombotic occlusion was comparable for both groups (0.74/patient-year versus 0.88/patient-year; P >.05). Mean graft flow at 1, 6, and 12 months was 1416 versus 1415 mL/min, 1345 versus 1319 mL/min, and 1595 versus 1265 mL/min (P >.05) for 4-mm to 7-mm and 6-mm grafts, respectively. Also, no differences in peak systolic velocities in any part of the grafts were observed. The percentage of stenoses detected was equal in both groups at 1 year after surgery (27% versus 20%; P >.05).

CONCLUSION: A 4-mm to 7-mm tapered prosthetic brachial-antecubital forearm loop access did not reduce the incidence rates of stenoses and thrombotic occlusions compared with a 6-mm prosthetic conduit. Moreover, no differences in patency rates were observed. Therefore, we believe that the 4-mm to 7-mm graft should not be used routinely for hemodialysis vascular access.