One single drug-coated balloon for all shapes/diameters? Neointimal proliferation inhibition in porcine peripheral arteries

Bienek, Stephanie; Kusmierczuk, Maciej; Schnorr, Beatrix; Gemeinhardt, Ole; Bettink, Stephanie; Scheller, Bruno

doi:10.1371/journal.pone.0280206

Cited by 1 publication

(1 citation statement)

References 19 publications

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“…Despite large-scale clinical adoption of DCBs in PAD therapy, their comparatively sparse use in the coronary circulation suggests that clinical potential has not been fully realized. , Clinical hesitation for broader DCB use is in part due to our incomplete understanding of the key determinants of therapeutic efficacy − and the associated lack of generalizable strategies to promote efficient component transfer from the device to the arterial wall. Comparative studies among current devices indicate that only a small fraction of coating material (<10%) is transferred to and resorbed by the arterial wall and most of the initial PTX dose (>90%) is lost to systemic circulationthis leads to ineffective and unpredictable patient outcomes and increases the risk of off-target drug effects. ,, …”

Section: Introductionmentioning

confidence: 99%

Hydrophilic Coating Microstructure Mediates Acute Drug Transfer in Drug-Coated Balloon Therapy

Shazly,

Eberth,

Kostelnik

et al. 2024

ACS Appl. Bio Mater.

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Drug-coated balloon (DCB) therapy is a promising endovascular treatment for obstructive arterial disease. The goal of DCB therapy is restoration of lumen patency in a stenotic vessel, whereby balloon deployment both mechanically compresses the offending lesion and locally delivers an antiproliferative drug, most commonly paclitaxel (PTX) or derivative compounds, to the arterial wall. Favorable long-term outcomes of DCB therapy thus require predictable and adequate PTX delivery, a process facilitated by coating excipients that promotes rapid drug transfer during the inflation period. While a variety of excipients have been considered in DCB design, there is a lack of understanding about the coating-specific biophysical determinants of essential device function, namely, acute drug transfer. We consider two hydrophilic excipients for PTX delivery, urea (UR) and poly(ethylene glycol) (PEG), and examine how compositional and preparational variables in the balloon surface spray-coating process impact resultant coating microstructure and in turn acute PTX transfer to the arterial wall. Specifically, we use scanning electron image analyses to quantify how coating microstructure is altered by excipient solid content and balloon-to-nozzle spray distance during the coating procedure and correlate obtained microstructural descriptors of coating aggregation to the efficiency of acute PTX transfer in a one-dimensional ex vivo model of DCB deployment. Experimental results suggest that despite the qualitatively different coating surface microstructures and apparent PTX transfer mechanisms exhibited with these excipients, the drug delivery efficiency is generally enhanced by coating aggregation on the balloon surface. We illustrate this microstructure−function relation with a finite element-based computational model of DCB deployment, which along with our experimental findings suggests a general design principle to increase drug delivery efficiency across a broad range of DCB designs.

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