Paclitaxel retention of drug-coated balloons in veins and arteries under arteriovenous fistula hemodynamics.
- 1Department of Biomedical Engineering, Wake Forest University School of Medicine, Winston-Salem, NC, United States.
- 2Department of Engineering, Wake Forest University, Winston-Salem, NC, United States.
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.
Related
- A Randomised Trial of Paclitaxel Coated Balloons for Arteriovenous Fistula Stenosis with Blinded Re-intervention Criteria
- Drug-coated balloons in coronary disease: meta-analysis comparing sirolimus- and paclitaxel-coated technologies
- Multiscale hemodynamics model for the pulmonary arteries, arterioles, capillaries, venules and veins
- Drug coated balloons versus drug eluting stents for de novo coronary artery disease: a systematic review and meta-analysis of randomised controlled trials
- Coronary Drug-Coated Balloons as Brief-Contact Drug-Delivery Platforms: Engineering, Tissue Pharmacokinetics, and Angiographic/Imaging Response
BibTeX
@article{liu2026paclitaxel,
title = {{Paclitaxel retention of drug-coated balloons in veins and arteries under arteriovenous fistula hemodynamics.}},
author = {Linda B Liu and Kayla Lowry and Brystol Habermacher and Saami K Yazdani},
journal = {Frontiers in cardiovascular medicine},
year = {2026},
month = oct,
doi = {10.3389/fcvm.2026.1888798},
url = {https://europepmc.org/article/MED/42908546},
note = {CC BY},
}
RIS
TY - JOUR
TI - Paclitaxel retention of drug-coated balloons in veins and arteries under arteriovenous fistula hemodynamics.
AU - Linda B Liu
AU - Kayla Lowry
AU - Brystol Habermacher
AU - Saami K Yazdani
PY - 2026
DA - 2026/10/07
JO - Frontiers in cardiovascular medicine
DO - 10.3389/fcvm.2026.1888798
UR - https://europepmc.org/article/MED/42908546
AB - 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.
SN - 2297-055X
ER -