A prospective randomized study of stent graft placement after balloon angioplasty versus balloon angioplasty alone for the treatment of hemodialysis patients with prosthetic graft outflow stenosis.

Abstract

Hemodialysis graft outflow stenosis is a significant complication occurring in hemodialysis patients with prosthetic grafts for vascular access. Balloon angioplasty remains the first-line endovascular treatment of this complication, although covered stent graft implantation after balloon angioplasty also appears to be an effective and promising treatment. The aim of this study was to evaluate the efficacy and durability of stent graft placement after balloon angioplasty in comparison to balloon angioplasty alone for the treatment of graft outflow stenosis in hemodialysis patients. We conducted a prospective randomized study of 98 patients with clinically significant dialysis graft outflow stenosis treated in the vascular surgery section of a tertiary medical center. The patients were randomized into two groups; 49 patients were treated with stent graft placement after balloon angioplasty, and 49 patients were treated with balloon angioplasty alone. All patients underwent angiography of the graft site at 3 and 6 months after intervention, and restenosis rates were compared between the two groups. In addition, the duration of postintervention primary patency in the two groups was recorded and analyzed. The postintervention restenosis rate of the stent graft placement group was superior to that seen in the balloon angioplasty alone group (9% vs 69% at 3 months [P < .0001] and 29% vs 72% at 6 months [P < .0001]). The mean postintervention primary patency duration was 380.22 ± 28.54 days for the stent graft placement group and 151.08 ± 16.79 days for the balloon angioplasty alone group (P < .0001). The use of stent grafts in hemodialysis patients with graft outflow stenosis yielded superior results compared with the results seen in hemodialysis patients treated with balloon angioplasty alone. Patients treated with stent grafts after balloon angioplasty had a lower restenosis rate and a longer duration of postintervention primary patency. The placement of a stent graft after balloon angioplasty appears to be an optimal therapeutic approach for the treatment of hemodialysis patients with graft outflow stenosis.