Polymer-Free Drug-Eluting Stents: An Overview of Coating Strategies and Comparison with Polymer-Coated Drug-Eluting Stents

Chen, Weiluan; Habraken, Tom C J; Hennink, Wim E.; Kok, Robbert J.

doi:10.1021/acs.bioconjchem.5b00192

Cited by 70 publications

(55 citation statements)

References 79 publications

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“…Stents are hollow devices that are inserted in an obstructed natural passage (such as the coronary artery) to open and prevent its blockage (Chen et al, 2015;Lei et al, 2011). Since 1986, bare metal stents (BMS) have been used to treat stenosis (Puel et al, 1987;Roguin, 2011), however, one of the most common problems with these stents is neointimal proliferation (i.e., re-stenosis) (Chen et al, 2006).…”

Section: Introductionmentioning

confidence: 99%

Gefitinib/gefitinib microspheres loaded polyurethane constructs as drug-eluting stent coating

Chen

Clauser

Thiebes

et al. 2017

European Journal of Pharmaceutical Sciences

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One of the complications of bronchotracheal cancer is obstruction of the upper airways. Local tumor resection in combination with an airway stent can suppress intraluminal tumor (re)growth. We have investigated a novel drug-eluting stent coating for local release of the anticancer drug gefitinib. A polyurethane (PU) sandwich construct was prepared by a spray coating method in which gefitinib was embedded between a PU support layer of 200 μm and a PU top layer of 50-200 μm. Gefitinib was either embedded in the construct as small crystals or as gefitinib-loaded poly(lactic-co-glycolic acid) (PLGA) microspheres (MSP). The drug was incorporated in the PU constructs with high recovery (83-93%), and the spray coating procedure did not affect the morphologies of the embedded microspheres as demonstrated by scanning electron microscopy (SEM), confocal laser scanning microscopy and fluorescence microscopy analysis. PU constructs loaded with gefitinib crystals released the drug for 7-21 days and showed diffusion based release kinetics. Importantly, directional release of the drug towards the top layer, which is supposed to face the tumor mass, was controlled by the thicknesses of the PU top layer. PU constructs loaded with gefitinib microspheres released the drug in a sustained manner for N 6 months indicating that drug release from the microspheres became the rate limiting step. In conclusion, the sandwich structure of drug-loaded PLGA microspheres in PU coating is a promising coating for airway stents that release anticancer drugs locally for a prolonged time.

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Section: Introductionmentioning

confidence: 99%

Gefitinib/gefitinib microspheres loaded polyurethane constructs as drug-eluting stent coating

Chen

Clauser

Thiebes

et al. 2017

European Journal of Pharmaceutical Sciences

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“…Previous studies have suggested that the polymeric coating of DESs leads to ST by inducing a variety of detrimental effects, including triggering the proliferation of smooth muscle cells, blocking the endothelization of nearby tissue, provoking hypersensitivity reactions, and so forth . The utilization of BP coating significantly reduced long‐term side effects of the polymer .…”

Section: Discussionmentioning

confidence: 99%

Two‐year safety evaluation of a biodegradable polymer sirolimus‐eluting stent with increased drug elution and polymer absorption kinetics in complex patient and lesion cohort

Jia

Guan

Yuan

et al. 2019

Cathet Cardio Intervent

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Objectives: The aim of the present report was to compare 2-year safety outcomes of two biodegradable polymer (BP) sirolimus-eluting stents (SESs) with different drug eluting and polymer absorption kinetics in a subgroup of complex patients and lesions.Background: The previously published PANDA III study showed the BuMA BP SES, with faster drug elution and polymer absorption, was non-inferior to the Excel SES in target lesion failure (TLF).Methods: In PANDA III trial, patients who fulfilled one or more of the following criteria were included: Small vessel disease (reference vessel diameter ≤ 2.5 mm); long lesion (lesion length ≥ 20 mm); chronic total occlusion lesion; and diabetic patients.Results: Among 2,348 patients randomly assigned to treatment with BuMA (n = 1,174) or Excel SES (n = 1,174) in the PANDA III study, 858 in the BuMA group and 855 in the Excel group satisfied the inclusion criteria. At 2-year follow-up, the incidence of definite/probable stent thrombosis (ST) was significantly lower with BuMA SES as compared with Excel SES (0.7% vs. 1.9%, p = 0.03). This difference was mainly caused by decreased subacute stent thrombosis rate (0% vs. 0.6%, p = 0.03). In patients who did not fulfill the complex patient and lesion criteria, there were no between-group difference in ST (0.7% vs. 0%, p = 0.50). Myocardial infarction and TLF rates were similar (5.7% vs. 6.0%, p = 0.79 and 8.8% vs. 7.5%, p = 0.34, respectively), whereas patientoriented composite endpoint was higher with BuMA SES mainly due to high risk of revascularization (15.6% vs. 11.4%, p = 0.01; 8.4% vs. 4.6%, p < 0.01).Conclusions: Two-year subgroup analysis of the all-comer PANDA III trial revealed the increased safety benefit of the BuMA SES is more prominently seen in complex patient and lesion population.

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“…In general, commonly used DES can be divided into (a) polymer-coated; (b) polymer-free; (c) gene-eluting [182][183][184][185][186][187][188][189][190]; (d) nanoparticle-eluting; and (e) bioresorbable. [198,199] Biofreedom (Biosensors International)…”

Section: General Aspectsmentioning

confidence: 99%

Recent Advances in Manufacturing Innovative Stents

et al. 2020

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Cardiovascular diseases are the most distributed cause of death worldwide. Stenting of arteries as a percutaneous transluminal angioplasty procedure became a promising minimally invasive therapy based on re-opening narrowed arteries by stent insertion. In order to improve and optimize this method, many research groups are focusing on designing new or improving existent stents. Since the beginning of the stent development in 1986, starting with bare-metal stents (BMS), these devices have been continuously enhanced by applying new materials, developing stent coatings based on inorganic and organic compounds including drugs, nanoparticles or biological components such as genes and cells, as well as adapting stent designs with different fabrication technologies. Drug eluting stents (DES) have been developed to overcome the main shortcomings of BMS or coated stents. Coatings are mainly applied to control biocompatibility, degradation rate, protein adsorption, and allow adequate endothelialization in order to ensure better clinical outcome of BMS, reducing restenosis and thrombosis. As coating materials (i) organic polymers: polyurethanes, poly(ε-caprolactone), styrene-b-isobutylene-b-styrene, polyhydroxybutyrates, poly(lactide-co-glycolide), and phosphoryl choline; (ii) biological components: vascular endothelial growth factor (VEGF) and anti-CD34 antibody and (iii) inorganic coatings: noble metals, wide class of oxides, nitrides, silicide and carbide, hydroxyapatite, diamond-like carbon, and others are used. DES were developed to reduce the tissue hyperplasia and in-stent restenosis utilizing antiproliferative substances like paclitaxel, limus (siro-, zotaro-, evero-, bio-, amphi-, tacro-limus), ABT-578, tyrphostin AGL-2043, genes, etc. The innovative solutions aim at overcoming the main limitations of the stent technology, such as in-stent restenosis and stent thrombosis, while maintaining the prime requirements on biocompatibility, biodegradability, and mechanical behavior. This paper provides an overview of the existing stent types, their functionality, materials, and manufacturing conditions demonstrating the still huge potential for the development of promising stent solutions.

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Polymer-Free Drug-Eluting Stents: An Overview of Coating Strategies and Comparison with Polymer-Coated Drug-Eluting Stents

Cited by 70 publications

References 79 publications

Gefitinib/gefitinib microspheres loaded polyurethane constructs as drug-eluting stent coating

Gefitinib/gefitinib microspheres loaded polyurethane constructs as drug-eluting stent coating

Two‐year safety evaluation of a biodegradable polymer sirolimus‐eluting stent with increased drug elution and polymer absorption kinetics in complex patient and lesion cohort

Recent Advances in Manufacturing Innovative Stents

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