Abstract No. 27 The Effects of Patient and Procedural Variables of the Lutonix AV Global Registry: Results from the Arteriovenous Fistula Cohort

This is a post-hoc analysis of the results Lutonix AV Global Registry (outside United Sates) focusing exclusively on arteriovenous fistulas (AVFs) with inclusion criteria consistent to those IDE trial from States. Device under investigation was drug-coated balloon (DCB). 131 320 subjects met for in analysis. 59.5% (78/131) were male. 50.5% white and 45.7% Asian population. Among exploratory outcome measures safety (freedom adverse events at 30 days), efficacy [target lesion primary patency (TLPP) 6 months], effect inflation time pressure vessel preparation balloon. Primary endpoint days 95.2%. TLPP months 86.7% based Kaplan-Meier survival Subjects DCB between 2-3 minutes had 89.7% while 0–1 minute time, 78.6%. In where >25atm, 94.4%, < 25atm pressure, 84.7%. whose underwent >2 minutes, 89.8%. Median event 336 days. subgroup suggests that patients stenotic lesions treated DCB, procedural variables may influence outcomes. reintervention-free nearly year.