A Prospective Multicenter Randomized Controlled Trial for Comparing Drug-Coated and Conventional Balloon Angioplasty in Venous Anastomotic Stenosis of Hemodialysis Arteriovenous Grafts.

Abstract

To evaluate the efficacy and safety of drug-coated balloon angioplasty compared to conventional balloon angioplasty in the treatment of dysfunctional arteriovenous grafts. This prospective, multicenter, randomized clinical trial enrolled 190 patients with venous anastomotic stenosis in arteriovenous grafts at five participating hospitals. During pre-dilation, 4 patients dropped out due to ruptures requiring further treatment (n = 2) and residual stenosis of > 30% (n = 2). On successful pre-dilation with a 7mm conventional balloon, patients were randomized to undergo either a 7mm drug-coated balloon (n = 94) or conventional balloon angioplasty (n = 92). The primary out-come measure was target lesion primary patency at 3 and 6months. The secondary out-come measures included target lesion primary patency at 12months and access circuit primary patency at 6 and 12months, clinical and technical success rates, and 12-month mortality differences between the groups. The target lesion primary patency and access circuit patency rates at 3 and 6months were significantly higher in drug-coated balloon angioplasty group as compared to conventional balloon angioplasty group. The technical and clinical success rates were 100% for both the groups. As a procedure-related complication, anastomotic site rupture occurred during pre-dilation in 4 cases. The number of deaths during the 12-month follow-up was one for each group. The number of early thrombotic events (at < 3months) was significantly higher in the drug-coated balloon group (p = 0.002). Drug-coated balloon angioplasty was more effective and safer for the treatment of dysfunctional arteriovenous grafts compared to conventional balloon angioplasty.