• Scott O Trerotola, Theodore F Saad, Prabir Roy-Chaudhury, and Lutonix AV Clinical Trial Investigators.
• Department of Radiology, Perelman School of Medicine at the University of Pennsylvania, 1 Silverstein, 3400 Spruce St., Philadelphia, PA 19104. Electronic address: streroto@uphs.upenn.edu.
• J Vasc Interv Radiol. 2020 Jan 1; 31 (1): 1-14.e5.

PurposeTo present final, 2-year results of a randomized trial comparing paclitaxel-coated vs uncoated balloon angioplasty following vessel preparation with ultra-high-pressure percutaneous transluminal angioplasty (PTA) in hemodialysis arteriovenous fistulae (AVFs).Materials And MethodsTwenty-three sites enrolled 285 subjects with dysfunctional AVFs located in the arm. Before 1:1 randomization, successful vessel preparation was achieved (full waist effacement, < 30% residual stenosis). Follow-up was clinically driven except for a 6-month office visit.ResultsNinety-six of 141 subjects in the drug-coated balloon (DCB) arm and 111 of 144 in the control arm completed the study. Target lesion primary patency (TLPP) rates for the DCB and control groups were 58% ± 4 vs 46% ± 4 (P = .02) at 9 months, 44% ± 5 vs 36% ± 4 (P = .04) at 12 months, 34% ± 5 vs 28% ± 4 (P = .06) at 18 months, and 27% ± 4 vs 24% ± 4 (P = .09) at 24 months, respectively. Mean time to TLPP event for subjects with an event was longer for DCBs (322 vs 207 d; P < .0001). Fewer interventions were needed to maintain target lesion patency in the DCB group at 9 months (P = .02) but not at 12 (P = .08), 18 (P = .13), or 24 months (P = .19). The noninferiority safety target was met at all intervals (P < .01). Mortality did not differ between groups (P = .27). Post hoc analyses showed equivalent DCB effect in all subgroups.ConclusionsTwo-year results demonstrate long-term safety and variable efficacy of DCB angioplasty in AVFs.Copyright © 2019 SIR. Published by Elsevier Inc. All rights reserved.

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