Introduction
This document is a commentary on the review entitled "Nanotechnology in the development of cardiac stents" [1] focusing on clinical applications of stents.
Summary of History of Stent Development
Early diagnosis and treatment of atherosclerosis are of vital importance in cardiology. Because of high risk and complexity of open-heart surgery, nowadays balloon angioplasty and stent implantation are common techniques to extend arterial vessels narrowed by atherosclerosis. Serious drawbacks of previous stents, such as complications induced by delayed healing and local hypersensitivity reactions and so re-narrowing and vascular reocclusion, have led to the development of stent designs, stent delivery systems, ultrasonic guidance of stent situation, and high-pressure dilatation post-stenting modifications [2-5].
Bare metal stents (BMSs) have been designed based on inert metals, mostly cobalt chromium or stainless steel [6]. In order to avoid defections in BMSs, drug-eluting stents (DES), as the second generation of stents, were developed that utilized biodegradable or non-biodegradable materials to incorporate pharmacologic agents [6,7]. Advances in the stent platform and polymer coating led to introduction of third-generation devices [8]. Covered stents (CSs), with thin layer coating on metallic scaffolds of stent, reduce the risk of metallic ion release, internal hemorrhage and decrease radial pressure of the stent, prevent tissue ingrowth and thromboembolic release and simultaneously act as drug delivery platforms [9].
Nanotechnology Applications in Stent Development
Modifications based on nanotechnology can improve all three categories’ properties from the perspectives of hemocompatibility, platelet and monocyte adhesion, inflammatory activation, late neointimal and consequently the risk of late restenosis, mechanical strength, flexibility, and corrosion resistance. These modifications also provide reservoir for drug and gene delivery, obtaining sustained release profile to promote reendothelialization and reducing smooth muscle cell proliferation; and generally improving biocompatibility and safety profile [10-23].
The biocompatibility and hemocompatibility of an implant are very important issues because implants are in direct contact with the blood and tissues. Physical modification is easy and economical way to improve the surface characteristics of implants. In physical modifications, controlled and oriented micro- and nanopatterns are created on stents (Figure 1), based on different techniques. This category of modifications, because of related sizes to extracellular matrix components and a huge surface area, controls and directs the cell behavior on implanted biomedical materials [24,25]. Significant effects of oriented physical modifications on stent bio- and hemocompatibility are: (1) More corrosion resistance because of less metal ion release from intravascular stents (2) improvement of reendothelialization rate induced by enhancing attachment, uniform distribution and proliferation of endothelial cells (ECs) and (3) avoiding thrombogenicity to enhance hemocompatibility [26,27]. Combination of micro and nano-patterns on the implant surface produces synergistic effects in improving bio- and hemocompatibility [26].
Figure 1. Some examples of Physical modification on the surface of bare stent [1].
Chemical modifications, based on nanotechnology, is another solution to overcome drawbacks of primary stents. Bare stents (BS) with a covering film show the structural integrity and reduced radial pressure force to the vessel wall. A Covering film limits platelet adhesion and SMCs proliferation by providing a physical obstacle between the bloodstream and the endoluminal area of the vessel wall. It also offers a capable drug delivery system by enhancing mechanical properties and surface area [28-30]. Chemical modifications can be provided using polymeric, inorganic and carbon-based nanomaterials.
Biocompatible polymeric nanomaterial coatings prevent the release of ions from metallic alloy implants such as nitinol (NiTi), stainless steel, cobalt chromium and etc., in the human body, so they can reduce unwanted biological reactions and improve biocompatibility, mechanical properties and surface resistance [29,31-33].
Despite these advantages, release of acidic byproducts from some biodegradable polymers can lead to vigorous inflammatory reactions and so clinical failure. The composition of biodegradable polymers with nano-sized amorphous calcium phosphate (ACP) and magnesium hydroxide (Mg(OH)2) nanoparticles prevents the release of acidic byproducts, resulting from degradation of biodegradable polymers, and provide better biocompatibility and biomechanical properties [34-36]. Titanium oxides, with appropriate hemocompatibility, are used as coating for blood-contacting devices [37-39]. The appropriate surface free energy of TiO2 surfaces control the wettability, adsorption and as well as the interaction of the solid surface with proteins, cells, and microorganisms present in the surrounding liquid [40].
Coating with high oxidation resistant materials, as a barrier to oxygen, have increasingly attracted the attention of researchers for metal protection. Different carbon allotropes (i.e., carbon thin film, graphene (Gr), carbon nanotube (CNT), nanocrystalline diamond, etc.) and also carbon compounds such as graphene oxide (GO) have been applied for surface modification of cardiovascular stents. Gr with high oxidation resistance have increasingly attracted the attention of researchers, as a barrier to oxygen and new coating material for metal protection. Specifically, graphene coated nitinol (Gr–NiTi) induces better cell growth and proliferation and is widely used in the design of implants and stents. Moreover, excellent adsorption of serum albumin on Gr–NiTi leads to lower thrombosis rate. In general, various studies showed the modification using carbon nanomaterials and also composites of carbon nanomaterials and metal oxide nano-structures improves the reendothelialization, hemocompatibility, antithrombogenicity and biomechanical properties and reduces the restenosis and inflammation [18,41-48]. Obtained surfaces also affect the endothelial cell phenotype, diminish the endothelial-to-mesenchymal transition and thus reduce the risk of in-stent restenosis [42]. Figure 2 shows some examples of chemical modifications on stent surface.
Figure 2. Chemical modifications on bare stent. Nanofibers, TiO2 and Nano diamond are illustrating of polymeric, inorganic and carbon-based nano materials, respectively [1].
Organic and inorganic coatings have provided advantages in terms of chemical resistance, biocompatibility, drug loading and delivery. But these chemicals have no biological activity. Immobilization of bioactive molecules, such as extracellular matrix (ECM) molecules, cell-adhesive peptides, VEGF, proteins, and cell recognition peptides, have been considered to stimulate a positive response on the stent surface. These biological molecules have been used as biomimetic agents to confer hemocompatibility, reproduce natural biological structures at the molecular level and have the potential for accelerating healing of vascular stent lesions [49-51].
The impact of physical, chemical and biological modifications on stents improvement is discussed in detail in our review article [1].
Nowadays, the design of nanotechnology-based reservoirs for drug loading and targeted delivery is one of the attractive research fields [52,53]. Drug eluting stents (DESs) developed based on physical modifications and chemical coatings in stents to provide a capacity for drug loading and delivery [54-61]. Nanotechnology introduces structures with capabilities such as drug solubility regulation, dug transport and targeted drug delivery and so, improves effectiveness and controls side effects of drugs. Chemical and biological agents can be loaded in biocompatible nano-reservoirs, such as nanoliposomes, polymeric nanofibers, mesoporous NPs and etc. in stent structure for local and controlled drug delivery [20,62-66]. The fiber and polymer network could function as a reservoir to support the immobilization of biomimetic coatings for anti-coagulant, anti-inflammatory and reendothelialization promotion properties [61,67-69]. Liposomes, as drug carriers, have attracted much attention due to biodegradability, ability to carry both hydrophobic and hydrophilic materials at the same time and also drug transportation ability through biological membranes [20]. The development of multi-agent drug delivery systems increases efficacy and reduces side effects through synergistic effect and reducing the amount of drug required [68]. Coupling shockwave therapy to stents can be applied to break down calcium in arteries using sonic waves [70].
In the future, loading different therapeutic, imaging and targeting agents on stents will develop theranostic systems (Figure 3) [71-75]. Smart stents, equipped with different imaging, sensing, targeting and therapeutic agents can control post-implant conditions [76,77]. 3D-printing technology can provide personalized stents from biodegradable materials which will improve clinical consequences [78]. Using smart materials such as photo-crosslinked resins can provide high print resolution and so, sophisticated and smaller structures with intricate features [79].
Figure 3. A smart stent [80].
Conclusion
Our study shows that nowadays the most common stents in the clinic are those made based on cobalt chromium and coated with biodegradable polymers containing potent immunosuppressant and anti-proliferative agents. Stents, despite being used for decades, still have considerable research potential. It is hoped that nanotechnology, by introducing new materials, synthesis techniques, fabrication methods and structures, will be able to design and construct next-generation coronary stents, to address the challenges of present-day stents. Such systems will provide in- and post-operative monitoring in order to reduce the need for subsequent invasive interventions and so provide high efficiency and safety of treatments. Along with the development of nanotechnology applications in the treatment of cardiovascular diseases, it is necessary to carry out sufficient and accurate studies on the safety and potential toxic effects of nanostructures on the body, scale up of fabrication techniques to an industrial level and extensive validation studies in preclinical and clinical trials to approve the next generation nanotechnology-based devices.
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