Paclitaxel-coated expanded polytetrafluoroethylene haemodialysis grafts inhibit neointimal hyperplasia in porcine model of graft stenosis

Lee, Byung Ha; Nam, Hye Yeong; Kwon, Taegun; Kim, Sung Joo; Kwon, Ghee Young; Jeon, Hae Myung; Lim, Hyun Jung; Lee, Woo Kyoung; Park, Jong‐Sang; Ko, Jai Young; Kim, Dae Joong

doi:10.1093/ndt/gfl070

Cited by 49 publications

(34 citation statements)

References 20 publications

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“…Paclitaxel (PAT) is one such drug which is also commonly used for treating in-stent restenosis [37]. PAT has been shown to strongly adsorb onto different materials including glass [35], polypropylene [35], silicones [35], and polytetrafluoroethylene [38]. In this study, we have explored the use of strong adhesion property of PAT to coat these molecules directly on Co–Cr alloy, a material which is used for making ultra-thin stent struts, and have investigated the in vitro drug release profiles of this system for up to 56 days.…”

Section: Introductionmentioning

confidence: 99%

Delivery of paclitaxel from cobalt–chromium alloy surfaces without polymeric carriers

et al. 2010

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Polymer-based carriers are commonly used to deliver drugs from stents. However, adverse responses to polymer coatings have raised serious concerns. This research is focused on delivering drugs from stents without using polymers or any carriers. Paclitaxel (PAT), an anti-restenotic drug, has strong adhesion towards a variety of material surfaces. In this study, we have utilized such natural adhesion property of PAT to attach these molecules directly to cobalt–chromium (Co–Cr) alloy, an ultra-thin stent strut material. Four different groups of drug coated specimens were prepared by directly adding PAT to Co–Cr alloy surfaces: Group-A (PAT coated, unheated, and ethanol cleaned); Group-B (PAT coated, heat treated, and ethanol cleaned); Group-C (PAT coated, unheated, and not ethanol cleaned); and Group-D (PAT coated, heat treated and not ethanol cleaned). In vitro drug release of these specimens was investigated using high performance liquid chromatography. Groups A and B showed sustained PAT release for up to 56 days. A simple ethanol cleaning procedure after PAT deposition can remove the loosely bound drug crystals from the alloy surfaces and thereby allowing the remaining strongly bound drug molecules to be released at a sustained rate. The heat treatment after PAT coating further improved the stability of PAT on Co–Cr alloy and allowed the drug to be delivered at a much slower rate, especially during the initial 7 days. The specimens which were not cleaned in ethanol, Groups C and D, showed burst release. PAT coated Co–Cr alloy specimens were thoroughly characterized using scanning electron microscopy, atomic force microscopy, and X-ray photoelectron spectroscopy. These techniques were collectively useful in studying the morphology, distribution, and attachment of PAT molecules on Co–Cr alloy surfaces. Thus, this study suggests the potential for delivering paclitaxel from Co–Cr alloy surfaces without using any carriers.

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Section: Introductionmentioning

confidence: 99%

Delivery of paclitaxel from cobalt–chromium alloy surfaces without polymeric carriers

et al. 2010

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“…[3][4][5][6][7][8][9] We previously reported that paclitaxel coating of ePTFE grafts was effective in suppressing such neointimal hyperplasia and stenosis. 10,11 Various methods of coating were also developed for controlled drug delivery, such as the dipping method, double dipping, 12 and loading of paclitaxel nanoparticles onto ePTFE vascular grafts. 13 With our previous dip-coating methods, paclitaxel was coated equally on the inner and outer surfaces of the graft.…”

mentioning

confidence: 99%

Paclitaxel coating of the luminal surface of hemodialysis grafts with effective suppression of neointimal hyperplasia

Baek

Bai

Hwang

et al. 2012

Journal of Vascular Surgery

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“…The strong adhesion of PAT toward PTFE material has been previously demonstrated. 7 In this study, when the drug was infused using the excipient solutions such as urea-PAT, iodixanol-PAT, and Ctrl-Saline-PAT, a large amount of PAT was strongly adsorbed on the balloon material (PTFE) surfaces and not infused out [ Figure 3(A)]. However, for the excipient solutions such as Cremophor-PAT and nab-PAT, only a lesser amount of PAT was adsorbed on the balloon material surface and not infused out [ Figure 3(A)].…”

Section: Discussionmentioning

confidence: 99%

In vitro and in vivo evaluation of effect of excipients in local delivery of paclitaxel using microporous infusion balloon catheters

et al. 2015

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Drug-infusion balloons are one of the currently used local drug delivery devices for preventing restenosis after endovascular treatments. An antiproliferative drug (paclitaxel, PAT) is infused through the balloon using a cremophor-based formulation to control restenosis. However, the major limitations of this approach are poor in vivo drug uptake and a limit in the amount of PAT delivered because of cremophor toxicity. In this study, we have investigated the use of different excipients for effectively infusing PAT out of the balloon for improved drug uptake in the tissue. The excipients include nanoparticle albumin-bound PAT (nab-PAT, a nanobiomaterial used in cancer therapy), urea (a hydrophilic agent used for faster drug transfer), iodixanol (a contrast agent used for coronary angiography), and cremophor-PAT (the most commonly used PAT formulation). An in vitro drug release, smooth muscle cell (SMC) response, endothelial cell (EC) response, and in vivo drug uptake were investigated for all the different excipients of PAT infused through the balloon. The nab-PAT was as effective as cremophor in infusing out of the balloon and inhibiting SMC growth. Also, nab-PAT showed a significantly greater amount of in vivo PAT uptake than that of cremophor-PAT. Urea and iodixanol were not effective in delivering a clinically relevant dose of PAT due to the poor solubility of PAT in these excipients. Urea eradicated all the SMCs and ECs, suggesting a toxic effect, which impedes its use in balloon-based therapy. Thus, this study demonstrated that nab-PAT is an effective formulation to locally deliver PAT through infusion balloons. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 376-390, 2017.

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Paclitaxel-coated expanded polytetrafluoroethylene haemodialysis grafts inhibit neointimal hyperplasia in porcine model of graft stenosis

Abstract: Paclitaxel-coated ePTFE grafts could prevent neointimal hyperplasia and the stenosis of AV haemodialysis grafts.

Cited by 49 publications

References 20 publications

Delivery of paclitaxel from cobalt–chromium alloy surfaces without polymeric carriers

Delivery of paclitaxel from cobalt–chromium alloy surfaces without polymeric carriers

Paclitaxel coating of the luminal surface of hemodialysis grafts with effective suppression of neointimal hyperplasia

In vitro and in vivo evaluation of effect of excipients in local delivery of paclitaxel using microporous infusion balloon catheters

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