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

Abstract

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