IN.PACT AV Access randomized trial update: 3-year clinical results by anatomic and demographic subsets and 5-year extension mortality analysis.

PURPOSE: To report 36-month outcomes by anatomic and demographic subsets, and mortality through 60 months from the IN.PACT AV Access Study, a prospective, multicenter, randomized trial of a paclitaxel drug-coated balloon (DCB) versus percutaneous transluminal angioplasty (PTA) for dysfunctional hemodialysis arteriovenous fistulas (AVF). METHODS: The IN.PACT AV Access Study enrolled 330 participants at 29 international sites and randomized 1:1 to DCB (n = 170) or PTA (n = 160). Target lesion primary patency (TLPP) outcomes through 36 months were stratified by core laboratory-adjudicated anatomic subsets: lesion types (de novo and restenotic), AVF type (radiocephalic and brachiocephalic/ brachiobasilic), and lesion locations (peri-anastomotic, cephalic arch, and venous outflow). TLPP outcomes were also stratified by participant demographics. Mortality rates were reported through 60 months. RESULTS: Through 36 months, DCB showed numerically or statistically greater TLPP compared to PTA in de novo (50.6% versus 42.2%, p = 0.175) and restenotic (40.5% versus 22.7%, p < 0.001) lesions. Similarly, 36-month TLPP was significantly better for DCB compared to PTA in radiocephalic (44.5% versus 33.8%, p = 0.039) and brachiocephalic/ brachiobasilic (39.9% versus 21.3%, p = 0.011) AVFs. In lesion location subsets, 36-month TLPP was numerically greater with DCB versus PTA: peri-anastomotic (40.4% versus 31.1%, p = 0.047), cephalic arch (40.9% versus 27.9%, p = 0.079), and venous outflow (45.6% versus 25.5%, p = 0.048). Through 36 months, TLPP favored DCB treatment over PTA across race and sex. After incorporating additional vital status information, sixty-month freedom from all-cause mortality was 59.0% DCB versus 53.5% PTA (p = 0.510). CONCLUSION: Results showed sustained TLPP benefit for DCB compared to PTA in all subset analyses through 36 months and no mortality signal for DCB through 5 years. TRIAL REGISTRATION: ClinicalTrials.gov NCT03041467 . Registered 01 February 2017. LEVEL OF EVIDENCE: Level 1b, Randomized controlled trial.