The Lutonix AV Randomized Trial of Paclitaxel-Coated Balloons in Arteriovenous Fistula Stenosis: 2-Year Results and Subgroup Analysis |
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Institution: | 1. Department of Radiology, Perelman School of Medicine at the University of Pennsylvania, 1 Silverstein, 3400 Spruce St., Philadelphia, PA 19104;2. Section of Renal and Hypertensive Diseases, Christiana Care Health System, Newark, Delaware;3. University of North Carolina Kidney Center, Chapel Hill, North Carolina |
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Abstract: | 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. |
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Keywords: | ACPP"} {"#name":"keyword" "$":{"id":"kwrd0015"} "$$":[{"#name":"text" "_":"access circuit primary patency AVF"} {"#name":"keyword" "$":{"id":"kwrd0025"} "$$":[{"#name":"text" "_":"arteriovenous fistula AVG"} {"#name":"keyword" "$":{"id":"kwrd0035"} "$$":[{"#name":"text" "_":"arteriovenous graft CONSORT"} {"#name":"keyword" "$":{"id":"kwrd0045"} "$$":[{"#name":"text" "_":"Consolidated Standards of Reporting Trials DCB"} {"#name":"keyword" "$":{"id":"kwrd0055"} "$$":[{"#name":"text" "_":"drug-coated balloon ESRD"} {"#name":"keyword" "$":{"id":"kwrd0065"} "$$":[{"#name":"text" "_":"end-stage renal disease RVD"} {"#name":"keyword" "$":{"id":"kwrd0075"} "$$":[{"#name":"text" "_":"reference vessel diameter TLP"} {"#name":"keyword" "$":{"id":"kwrd0085"} "$$":[{"#name":"text" "_":"target lesion patency TLPP"} {"#name":"keyword" "$":{"id":"kwrd0095"} "$$":[{"#name":"text" "_":"target lesion primary patency |
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