Paclitaxel retention of drug-coated balloons in veins and arteries under arteriovenous fistula hemodynamics
Year: 2026
Type: article
Abstract: Introduction Arteriovenous fistulas (AVFs) are the preferred vascular access for hemodialysis, but venous stenosis remains a major limitation to long-term patency. Drug-coated balloons (DCBs) have emerged as a promising therapy to inhibit neointimal hyperplasia and reduce restenosis. However, inconsistent clinical outcomes have limited their adoption for AVF stenosis. The unique AVF environment—characterized by high flow, turbulent shear stress, and alternating arterial and venous segments—may influence drug transfer and retention within the vessel wall. Despite its importance, the impact of tissue type under AVF-specific hemodynamics on DCB performance remains poorly understood. This study investigates paclitaxel retention in venous and arterial tissue under simulated AVF conditions using an ex vivo bioreactor system. Materials and methods The IN.PACT™ AV paclitaxel-coated balloon was deployed for 2 min in porcine veins and arteries within an ex vivo AVF-simulating bioreactor. Treated vessel segments were collected at 1- and 24 h to quantify tissue paclitaxel concentration. Scanning electron microscopy (SEM) was performed at 1 h to assess coating deposition on the luminal surface. Results Hemodynamic conditions were comparable between venous and arterial groups, confirming physiologically relevant AVF flow and pressure. On log-transformed tissue paclitaxel concentrations, no statistically significant difference was detected between tissue types at either time point (two-way ANOVA, p = 0.163; adjusted geometric mean ratio [vein/artery] = 2.69, 95% CI: 0.65–11.18), and drug levels decreased from 1- to 24 h in both groups. Venous samples exhibited greater variability, particularly at 1 h. SEM analysis revealed heterogeneous coating transfer in both tissues, with clustered deposits in veins and more distributed coverage in arteries. Conclusion This study establishes an ex vivo platform for mechanistic evaluation of catheter-based drug delivery in vascular access. Under AVF hemodynamics, no statistically significant difference in acute paclitaxel retention was observed between venous and arterial tissues despite structural differences (log-scale two-way ANOVA, adjusted geometric mean ratio [vein/artery] = 2.69, 95% CI: 0.65–11.18). This absence of detectable differences suggests that tissue type alone does not drive DCB performance in AVFs.
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,801
OpenAlex ID: W7220855657