To 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 Methods
Twenty-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.
Ninety-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.
Two-year results demonstrate long-term safety and variable efficacy of DCB angioplasty in AVFs.
Structured Education breakdown:
|DISCIPLINE||MAJOR CONTENT CATEGORY & SUBCATEGORIES||CE CREDITS PROVIDED|
|RA – 2017||Safety|
|Radiation Protection and Equipment Operation||1.00|
|RA – 2018||Safety|
|Patient Safety, Radiation Protection, and Equipment Operation||1.00|
|VI – 2016||Procedures|
|Peripheral Angiography and Intervention, Dialysis Management, and Venous Access||0.50|
|VI – 2017||Procedures|
|Vascular Diagnostic Procedures||0.50|