Escuer, J., Fensterseifer Schmidt, A., Peña, E., Martínez, M. A. and McGinty, S. (2022) Mathematical modelling of endovascular drug delivery: balloons versus stents. International Journal of Pharmaceutics, 620, 121742. (doi: 10.1016/j.ijpharm.2022.121742) (PMID:35427751)
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Abstract
The most common treatment for obstructive coronary artery disease (CAD) is the implantation of a permanent drug-eluting stent (DES). Not only has this permanency been associated with delayed healing of the artery, but it also poses challenges when treating subsequent re-narrowing due to in-stent restenosis (ISR). Drug-coated balloons (DCBs) provide a potential solution to each of these issues. While their use has been primarily limited to treating ISR, in recent years, DCBs have emerged as an attractive potential alternative to DESs for the treatment of certain de novo lesions. However, there remain a number of concerns related to the safety and efficacy of these devices. Firstly, unlike DESs, DCBs necessitate a very short drug delivery window, favouring a higher drug loading. Secondly, while the majority of coronary DCBs in Europe are coated with paclitaxel, the potential mortality signal raised with paclitaxel DCBs in peripheral interventions has shifted efforts towards the development of limus-eluting balloons. The purpose of this paper is to provide a computational model that allows drug delivery from DCBs and DESs to be investigated and compared. We present a comprehensive computational framework that employs a 2D-axisymmetric geometry, incorporates two nonlinear phases of drug binding (specific and non-specific) and includes the influence of diffusion and advection, within a multilayer arterial wall. We utilise this framework to (i) simulate drug delivery from different types of balloon platform; (ii) explore the influence of DCB application time; (iii) elucidate the importance on release kinetics of elevated pressure during DCB application; (iv) compare DCB delivery of two different drugs (sirolimus and paclitaxel) and; (v) compare simulations of DESs versus DCBs. Key measures of comparison are related to safety (drug content in tissue, DC) and efficacy (specific binding site saturation, ) markers. Our results highlight the pros and cons of each device in terms of DC and levels achieved and, moreover, indicate the potential for designing a DCB that gives rise to sufficiently similar safety and efficacy indicators as current commercial DESs.
| Item Type: | Articles |
|---|---|
| Additional Information: | This work was funded by the Spanish Ministry of Economy, Industry and Competitiveness through research project number PID2019-107517RB-I00; the Department of Industry and Innovation (Government of Aragon) through research group grant number T24-20R (Fondo Social Europeo); and the Carlos III Health Institute (ISCIII) through the CIBER initiative. Dr. McGinty acknowledges funding provided by EPSRC (Grant number EP/S030875/1). |
| Status: | Published |
| Refereed: | Yes |
| Glasgow Author(s) Enlighten ID: | Fensterseifer Schmidt, André and Mcginty, Dr Sean |
| Authors: | Escuer, J., Fensterseifer Schmidt, A., Peña, E., Martínez, M. A., and McGinty, S. |
| College/School: | College of Science and Engineering > School of Engineering > Biomedical Engineering |
| Journal Name: | International Journal of Pharmaceutics |
| Publisher: | Elsevier |
| ISSN: | 0378-5173 |
| ISSN (Online): | 1873-3476 |
| Published Online: | 12 April 2022 |
| Copyright Holders: | Copyright © 2022 The Authors |
| First Published: | First published in International Journal of Pharmaceutics 620: 121742 |
| Publisher Policy: | Reproduced under a Creative Commons License |
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