Randomized controlled trial comparing standard balloon angioplasty, placement of drug-eluting stent versus stent graft for the treatment of cephalic arch stenosis in patients with hemodialysis access stenoses

This study is to assess the efficacy of drug eluting stent or stent graft placement after balloon angioplasty compared to balloon angioplasty alone for the treatment of cephalic arch stenosis in patients undergoing percutaneous transluminal angioplasty of hemodialysis access arteriovenous fistula (AVF) or graft (AVG) stenoses at 6 months. From September 2012 to March 2014, 28 patients (16 males) with cephalic arch stenosis >50% were randomized to balloon angioplasty (PTA) (n=4); or PTA with drug-eluting stent placement (DES) (n=12); or PTA with stent graft placement (SG) (n=12). Mean age was 60 years (range 48-80). Follow-up angiograms were performed at 6 months to assess restenosis rates. Outcomes were circuit and lesion primary patency rates at 3 and 6 months. Baseline characteristics were similar between groups. Before 6-month follow-up angiogram, all 4 patients in the PTA group (100%), 9 patients in the DES group (75 %) and 4 patients in the SG group (33%) underwent intervention. At 3 months, circuit primary patency rates in the PTA, DES and SG groups were 50%, 84% and 84% respectively (p=0.001) and lesion primary patency were 50%, 84% and 84% respectively (p= 0.002). At 6 months, circuit primary patency rates in the PTA, DES and SG groups were 0%, 25% and 66% respectively (p= 0.001) and lesion primary patency rates were 0%, 42% and 67% respectively (p= 0.002). Limitations at this point are small sample size, unequal distribution between groups and restenosis rates. Stent graft placement for cephalic arch stenosis significantly improved circuit and lesion primary patency compared to PTA alone and PTA with DES placement at 6 months. It would be interesting to see whether this significant trend is maintained with a larger group of patients.