Prospective randomized trial of a metallic intravascular stent in hemodialysis graft maintenance

PURPOSE: To evaluate percutaneous transluminal angioplasty (PTA) alone versus PTA and flexible self-expanding stent placement for the management of hemodialysis access graft stenoses. MATERIALS AND METHODS: Thirty-seven grafts in 34 patients were evaluated for abnormal intradialytic parameters (n = 27) or occlusion (n = 10). Angiography identified stenoses (mean, 69%; range, 50%-95%) at or within 3 cm of the vein-graft junction (70%) or in the peripheral outflow vein (30%) that bad recurred within a 6-month period after previous PTA. They were randomized to PTA alone (n = 20) or PTA with Wallstent (n = 17). Additional lesions were treated by PTA alone, and a mean of 1.4 (range, 1-3) lesions were treated per patient. Significant differences existed in the mean number of previous accesses (1.8 and 0.8 in the PTA and stent groups, respectively) and in the mean number of previous interventions in the current access (1.8 and 2.9, respectively). End points were subsequent radiologic or surgical intervention, transplantation, and death. RESULTS: Technical success was 100% (mean residual stenosis, 12%; range, 0%-30%). The primary patency of 128 days and secondary patency of 431 days were similar for both groups. Secondary patency required a mean of 1.8 and 1.6 additional interventions for the PTA and stent groups, respectively. The adjunctive stent placement increased the cost of the procedure by 90%. CONCLUSION: Despite significant added costs, there was no advantage to stent placement for recurrent peripheral hemodialysis graft stenoses that were already adequately dilated with balloon angioplasty.