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| | {{Short description|A type of stent that is absorbed by the body after fulfilling its purpose}} |
| {{Infobox medical intervention | | {{Infobox medical intervention |
| | name = Bioresorbable stent | | | name = Bioresorbable stent |
| | synonym =
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| | image = Bioresorbable stent.jpg | | | image = Bioresorbable stent.jpg |
| | caption = A bioresorbable stent implanted in the blood vessel. | | | caption = A bioresorbable stent implanted in a blood vessel |
| | alt = | | | alt = Image of a bioresorbable stent in situ |
| | pronounce = | | | pronounce = |
| | specialty =vascular system | | | specialty = [[Cardiology]], [[Vascular surgery]] |
| | synonyms = | | | synonyms = Bioabsorbable stent, biodegradable stent |
| | ICD10 = | | | ICD10 = |
| | ICD9 = | | | ICD9 = |
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| | eMedicine = | | | eMedicine = |
| }} | | }} |
| | A '''bioresorbable stent''', also known as a '''bioresorbable vascular scaffold''' (BVS), is a type of [[stent]] used in [[interventional cardiology]] to treat narrowed or blocked [[coronary arteries]]. Unlike traditional [[metal stents]], bioresorbable stents are designed to be absorbed by the body over time, leaving behind a natural vessel. |
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| In medicine, a '''[[stent]]''' is any device which is inserted into a [[blood vessel]] or other internal duct in order to expand the vessel to prevent or alleviate a blockage. Traditionally, such devices are fabricated from metal mesh and remain in the body permanently or until removed through further surgical intervention. A '''bioresorbable stent''', (also called bioresorbable scaffold, biodegradable, or naturally-dissolving) serves the same purpose, but is manufactured from a material that may dissolve or be absorbed in the body.
| | ==Design and Composition== |
| | Bioresorbable stents are typically made from materials such as [[polylactic acid]] (PLA) or [[poly-L-lactic acid]] (PLLA), which are biodegradable polymers. These materials are chosen for their ability to provide temporary support to the artery while gradually dissolving into naturally occurring substances in the body, such as [[carbon dioxide]] and [[water]]. |
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| ==Background== | | ==Mechanism of Action== |
| The use of metal [[drug-eluting stent]]s presents some potential drawbacks. These include a predisposition to late stent [[thrombosis]], prevention of late vessel adaptive or expansive remodeling, hindrance of surgical revascularization, and impairment of imaging with multislice [[computed tomography|CT]].<ref>{{cite journal|last=Serruys|first=PW|author2=Ormiston JA |author3=Onuma Y |title=A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods|journal=Lancet|date=14 March 2009|volume=373|pages=897–910|pmid=19286089|issue=9667|doi=10.1016/S0140-6736(09)60325-1|display-authors=etal}}</ref><ref>{{cite journal|last=Ormiston|first=JA |author2=Serruys PW |author3=Regar E|title=A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial|journal=Lancet|date=15 March 2008|volume=371|pages=899–907|pmid=18342684|issue=9616|doi=10.1016/S0140-6736(08)60415-8|display-authors=etal}}</ref> | | The primary function of a bioresorbable stent is to provide mechanical support to a narrowed artery, allowing it to remain open and restore adequate blood flow. Over time, as the artery heals and remodels, the stent is absorbed by the body, reducing the risk of long-term complications associated with permanent stents, such as [[stent thrombosis]] and [[in-stent restenosis]]. |
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| To overcome some of these potential drawbacks, several companies are pursuing the development of bioresorbable scaffolds or bioabsorbable stents. Like metal stents, placement of a bioresorbable stent will restore blood flow and support the vessel through the healing process. However, in the case of a bioresorbable stent, the stent will gradually resorb and be benignly cleared from the body, enabling a natural reconstruction of the arterial wall and restoration of vascular function.<ref>{{cite journal |last1=Williams |first1=PD |last2=Awan |first2=M |title=Stent selection for percutaneous coronary intervention |journal=Continuing Cardiology Education |date=2017 |volume=3 |issue=2 |doi=10.1002/cce2.54}}</ref>
| | ==Advantages== |
| | Bioresorbable stents offer several potential advantages over traditional stents: |
| | * '''Reduced Long-term Complications''': By being absorbed, they eliminate the risk of late stent thrombosis and reduce the incidence of restenosis. |
| | * '''Restoration of Natural Vessel Function''': Once absorbed, the vessel can regain its natural vasomotion and flexibility. |
| | * '''Improved Imaging''': The absence of a permanent metallic structure allows for better imaging with [[non-invasive imaging techniques]] such as [[MRI]]. |
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| Studies have shown that the most critical period of vessel healing is largely complete by approximately three to nine months.<ref>{{cite journal |last1=Williams |first1=PD |last2=Awan |first2=M |title=Stent selection for percutaneous coronary intervention |journal=Continuing Cardiology Education |date=2017 |volume=3 |issue=2 |pages=64–69 |doi=10.1002/cce2.54}}</ref><ref>{{cite journal|last=Serruys|first=PW|author2=Luijten HE |author3=Beatt KJ |title=Incidence of restenosis after successful coronary angioplasty: a time-related phenomenon. A quantitative angiographic study in 342 consecutive patients at 1, 2, 3, and 4 months.|journal=Circulation|date=February 1988|volume=77|issue=2|pages=361–71|pmid=2962786|doi=10.1161/01.CIR.77.2.361|display-authors=etal|url=http://repub.eur.nl/pub/4272}}</ref><ref>{{cite journal|last=Post|first=MJ|author2=Borst C|author3=Kuntz RE|title=The relative importance of arterial remodeling compared with intimal hyperplasia in lumen renarrowing after balloon angioplasty: a study in the normal rabbit and the hypercholesterolemic Yucatan micropig|journal=Circulation|year=1994|volume=89|pages=2816–2821|pmid=8205696|issue=6|doi=10.1161/01.CIR.89.6.2816}}</ref> Therefore, the goal of a bioresorbable or “temporary” stent is to fully support the vessel during this critical period, and then resorb from the body when it is no longer needed.
| | ==Challenges and Limitations== |
| | Despite their advantages, bioresorbable stents face several challenges: |
| | * '''Thicker Struts''': To provide adequate support, bioresorbable stents often have thicker struts compared to metallic stents, which can affect deliverability and increase the risk of early thrombosis. |
| | * '''Longer Absorption Time''': The complete absorption process can take several years, during which time the risk of complications remains. |
| | * '''Limited Data''': Long-term data on the safety and efficacy of bioresorbable stents is still being collected, and their use is not yet as widespread as traditional stents. |
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| == Base materials == | | ==Current Use and Research== |
| Bioabsorbable scaffolds, or naturally dissolving stents, that have been investigated include base materials that are either metals or polymers. While polymer-based scaffolds had a strong presence at first, they have meanwhile lost some appeal due to safety concerns and focus is now shifted more towards metallic magnesium-based scaffolds.<ref>{{cite news |last1=Husten |first1=Larry |title=Abbott Pulls Troubled Absorb Stent From European Market |url=http://www.cardiobrief.org/2017/04/06/abbott-pulls-troubled-absorb-stent-from-european-market/ |accessdate=20 February 2019 |work=CardioBrief}}</ref>
| | Bioresorbable stents are currently used in select patients and are the subject of ongoing research to improve their design and performance. Studies are focused on optimizing the materials used, reducing strut thickness, and enhancing the drug-eluting capabilities of these stents to improve outcomes. |
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| === Metal based === | | ==Related pages== |
| Metal stent candidates are [[iron]], [[magnesium]], [[zinc]] and their alloys.
| | * [[Stent]] |
| | * [[Coronary artery disease]] |
| | * [[Interventional cardiology]] |
| | * [[Polylactic acid]] |
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| [[Iron]] stents were shown using an ''in vivo'' evaluation method based on the murine abdominal aorta to generate an iron oxide-filled cavity in the vascular wall.<ref>{{cite journal|last=Pierson|first=D |author2=Edick J |author3=Tauscher A |author4=Pokorney E |author5=Bowen PK |author6=Gelbaugh JA |author7=Stinson J |author8=Getty H |author9=Lee CH |author10=Drelich J |author11=Goldman J|title=A simplified ''in vivo'' approach for evaluating the bioabsorbable behavior of candidate stent materials|journal=J Biomed Mater Res B|date=January 2012|volume=100B|issue=1|pages=58–67|doi=10.1002/jbm.b.31922|pmid=21905215}}</ref> This behavior significantly narrowed the lumen and generated a potential site for rupture of the endothelium after stent degradation. | | [[Category:Medical devices]] |
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| [[Magnesium]]-based scaffolds have been approved for use in several countries around the world. The only commercially available magnesium-based scaffold consists of a magnesium alloy, approximately 95% of which resorbs within one year of implantation.<ref>{{cite journal |last1=Joner |first1=M |last2=Ruppelt |first2=P |last3=Zumstein |first3=P |title=Preclinical Evaluation of Degradation Kinetics and Elemental Mapping of First and Second Generation Bioresorbable Magnesium Scaffolds |journal=EuroIntervention |date=2018 |volume=2 |issue=9 |pages=e1040–e1048 |doi=10.4244/EIJ-D-17-00708|pmid=29469029 }}</ref><ref>{{cite journal |last1=Haude |first1=M |last2=Erbel |first2=R |last3=Erne |title=Safety and performance of the Drug-Eluting Absorbable Metal Scaffold (DREAMS) in patients with de novo coronary lesions: 3-year results of the prospective, multicenter, first-in-man BIOSOLVE-I trial. |journal=EuroIntervention |date=2016 |volume=12 |issue=2}}</ref><ref>{{cite book|last=Kirkland|first=N|author2=Birbilis N|title=Magnesium Biomaterials: Design, Testing and Best Practice|year=2013|url=https://www.springer.com/materials/biomaterials/book/978-3-319-02122-5|location=New York |publisher=Springer |isbn=978-3-319-02123-2 |accessdate=2013 }}</ref> Thousands of commercially available magnesium-based scaffolds have been implanted. Promising clinical results suggest that magnesium-based scaffolds seem to be a viable option in delivering against the drawbacks of permanent stents.<ref>{{cite conference |last1=Kang-Yin Lee |first1=M |title=Twelve-Month Outcomes with a Resorbable Magnesium Scaffold in a Real-world Setting |journal=Presented at TCT |date=Sep 23, 2018 |id=ClinicalTrials.gov: NCT02817802 (n=2054; first 400 patients presented)|url=https://www.tctmd.com/slide/biosolve-iv-twelve-month-outcomes-resorbable-magnesium-scaffold-real-world-setting}}</ref><ref>{{cite journal |last1=Haude |first1=M |title=Imaging and Clinical Results with the latest Magmaris Magnesium-Based Scaffold |journal=Presented at TCT |date=September 22, 2018}}</ref><ref>{{cite journal |last1=Haude |first1=M |last2=Ince |first2=H |last3=Abizaid |first3=A |title=Long-term clinical data and multimodality imaging analysis of the BIOSOLVE-II study with the drug-eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries – BIOSOLVE-II |journal=Presented at EuroPCR |date=May 23, 2018}}</ref><ref>{{cite journal |last1=Haude |first1=M |last2=Erbel |first2=R |last3=Erne |title=Safety and performance of the Drug-Eluting Absorbable Metal Scaffold (DREAMS) in patients with de novo coronary lesions: 3-year results of the prospective, multicenter, first-in-man BIOSOLVE-I trial |journal=EuroIntervention |date=2016 |volume=12 |issue=2}}</ref> While degrading harmlessly, it has been shown to possess a functional degradation time of about 30 days ''in vivo''. This is much short of the three-to-six month window desired for bioabsorbable stents. Thus, much attention has been given to drastically reducing the rate of magnesium corrosion by alloying, coating, etc.<ref>{{cite book|last=Li|first=N|author2=Zheng Y|title=Novel magnesium alloys developed for biomedical application: a review|journal=Journal of Materials Science & Technology|year=2013|isbn=978-3-319-02123-2}}</ref> Many novel methods have surfaced to minimize the penetration rate and hydrogen evolution rate (or, in layman's terms, the [[corrosion]] rate). One of the most successful has involved the creation of [[bioabsorbable metallic glass]]es via rapid solidification. Other, alternative solutions have included the development of magnesium–[[rare-earth]] (Mg-RE) alloys, which benefit from the low [[cytotoxicity]] of RE elements. [[Coatings]] and sophisticated materials processing routes are currently being developed to further decrease the corrosion rate. However a number of issues remain limiting the further development of Mg biomaterials in general.<ref>{{cite journal|title=Magnesium biomaterials: past, present and future|last=Kirkland|first=Nicholas T.|journal=Corrosion Engineering, Science and Technology|year=2012|doi=10.1179/1743278212Y.0000000034|volume=47|issue=5|pages=322–328|hdl=10069/29852}}</ref>
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| Recently, [[zinc]] was shown to exhibit outstanding physiological corrosion behavior, meeting a benchmark penetration rate of 20 micrometers per year.<ref>{{cite journal|last=Bowen|first=PK|author2=Drelich J |author3=Goldman J |title=Zinc Exhibits Ideal Physiological Corrosion Behavior for Bioabsorbable Stents|journal=[[Advanced Materials]]|date=14 March 2013|pmid=23495090|doi=10.1002/adma.201300226|url=https://www.scribd.com/doc/130468782/Zinc-Exhibits-Ideal-Physiological-Corrosion-Behavior-for-Bioabsorbable-Stents|accessdate=15 March 2013 |volume=25 |issue=18 |pages=2577–82}}</ref> This contribution also asserts that zinc alloys generally meet or exceed mechanical behavior benchmarks (i.e. ductility and tensile strength). While promising, this material is relatively new, so further work is required to prove that zinc is a feasible base material for a stent.
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| ===Polymer-based===
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| Polymer-based stents have been approved for use in some countries around the world. These are based on poly(L-lactide) ([[Polylactic acid#Chemical and physical properties|PLLA]]), chosen because it is able to maintain a radially strong scaffold that breaks down over time into lactic acid, a naturally occurring molecule that the body can use for metabolism. Other polymers in development include tyrosine poly carbonate and salicylic acid.<ref>{{Cite journal
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| |vauthors=Gogas BD, Farooq V, Onuma Y, Serruys PW | year = 2012
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| | title = The ABSORB bioresorbable vascular scaffold: an evolution or revolution in interventional cardiology?
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| | journal = Hellenic J Cardiol.
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| | volume = 53
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| | issue = 4
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| | pages = 301–309
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| | id = 22796817
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| | url = http://www.hellenicjcardiol.org/archive/full_text/2012/4/2012_4_301.pdf
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| }}</ref>
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| An example of a naturally dissolving stent is the 'Absorb' stent 'produced by [[Abbott Laboratories|Abbott]] that has several design components and features: '''base scaffold''': a poly(L-lactide) polymer similar to that in dissolvable stitches is shaped into a tube made up of zigzag hoops linked together by bridges; drug-eluting layer': a mixture of poly-D, L-lactide (PDLLA) and everolimus; 'markers': a pair of radio-opaque platinum markers at the ends that allow the device to be visualized during angiography; 'delivery system': a balloon delivery system.
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| Recently however, Polymer-based scaffolds, in particular Poly-L-Lactide Acid (PLLA) scaffolds, have raised serious concerns on the scaffold performance particularly in terms of safety which led to the commercial discontinuation of the main representative Absorb.<ref>{{cite journal |last1=Montone |first1=RA |last2=Niccoli |first2=G |last3=De Marco |first3=F |last4=Minelli |first4=S |last5=D’Ascenzo |first5=F |last6=Testa |first6=L |last7=Bedogni |first7=F |last8=Crea |first8=F |title=Temporal trends in adverse events after everolimus-eluting bioresorbable vascular scaffold versus everolimus-eluting metallic stent implantation: A meta-analysis of randomized controlled trials |journal=Circulation |date=2017 |volume=135}}</ref><ref>{{cite journal |last1=Sorrentino |first1=S |last2=Giustino |first2=G |last3=Mehran |first3=R |last4=Kini |first4=AS |last5=Sharma |first5=SK |last6=Faggioni |first6=M |last7=Farhan |first7=S |last8=Vogel |first8=B |last9=Indolfi |first9=C |last10=Dangas |first10=GD |title=Everolimus-eluting bioresorbable scaffolds versus everolimus-eluting metallic stents |journal=J Am Coll Cardiol |date=2017 |issue=69}}</ref>
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| ==Clinical Research==
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| Clinical research has shown that resorbable scaffolds, or naturally dissolving stents, offer comparable efficacy and safety profile to drug-eluting stents. Specifically, the Magmaris resorbable magnesium scaffold has reported a favorable safety profile with low target lesion failure and scaffold thrombosis rates. These clinical results are comparable to thin-strutted drug-eluting stents in similar patient populations.<ref>{{cite journal |last1=Meredith |first1=I |last2=Verheye |first2=S |last3=Weissmann |first3=N |display-authors=et al |title=Six-month IVUS and two-year clinical outcomes in the EVOLVE FHU trial: a randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent |journal=EuroIntervention |date=2013 |volume=9}}</ref><ref>{{cite conference |last1=Stone |first1=G |title=Everolimus-Eluting Stents: SPIRIT and PLATINUM Update |journal=Presented at TCT |date=Oct 22–26, 2012 |id=ClinicalTrials.gov: NCT00180310 .NCT00180479, NCT00307047|url=https://docplayer.net/94030160-Tct2012-program-october-22-26-miami-beach-convention-center-miami-fl.html}}</ref><ref>{{cite journal |last1=Haude |first1=M |last2=Ince |first2=H |last3=Abizaid |first3=A |display-authors=et al |title=Long-term clinical data and multimodality imaging analysis of the BIOSOLVE-II study with the drug-eluting absorbable metal scaffold in the treatment of subjects with de novo lesions in native coronary arteries – BIOSOLVE-II |journal=Presented at EuroPCR |date=May 23, 2018}}</ref><ref>{{cite journal |last1=Haude |first1=M |last2=Ince |first2=H |last3=Kische |first3=S |title=Safety and Clinical Performance of the Drug Eluting Absorbable Metal Scaffold in the Treatment of Subjects with de Novo Lesions in Native Coronary Arteries at 12-month follow-up- BIOSOLVE-II and BIOSOLVE-III. |journal=Journal of the American College of Cardiology |date=2017 |volume=70 |issue=18 |pages=B6–B7 |doi=10.1016/j.jacc.2017.09.071}}</ref>
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| The Absorb naturally dissolving stent has also been investigated in single-arm trials and in randomized trials comparing it to a drug-eluting stent. Early and late major adverse cardiac events, revascularizations, and scaffold thromboses have been uncommon and similar to the Xience DES, a market leader in the drug eluting stent category.<ref>{{Cite journal
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| |author1=Ormiston JA |author2=Serruys PW |author3=Regar E |display-authors=et al | year = 2008
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| | title = A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial
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| | journal = Lancet
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| | volume = 371
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| | issue = 9616
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| | pages = 899–907
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| | doi = 10.1016/S0140-6736(08)60415-8
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| | id = 18342684
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| | pmid=18342684
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| }}</ref><ref name=serruys2009>{{cite journal | last1 = Serruys | first1 = PW | last2 = Ormiston | first2 = JA | last3 = Onuma | first3 = Y | display-authors=et al | year = 2009 | title = A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods | url = | journal = Lancet | volume = 373 | issue = 9667| pages = 897–910 | pmid = 19286089 | doi=10.1016/S0140-6736(09)60325-1}}</ref><ref name=serruys2014>{{cite journal | last1 = Serruys | first1 = PW | last2 = Onuma | first2 = Y | last3 = Garcia-Garcia | first3 = HM |display-authors=et al | year = 2014 | title = Dynamics of vessel wall changes following the implantation of the absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months | url = | journal = EuroIntervention | volume = 9 | issue = 11| pages = 1271–1284 | pmid = 24291783 | doi=10.4244/EIJV9I11A217}}</ref><ref>{{Cite journal
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| |author1=Serruys PW |author2=Chevalier B |author3=Dudek D |display-authors=et al | year = 2015
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| | title = A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial
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| | journal = Lancet
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| | volume = 385
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| | issue = 9962
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| | pages = 43–54
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| | doi = 10.1016/S0140-6736(14)61455-0
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| | pmid = 25230593
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| }}</ref><ref name=smits2014>Smits P, Ziekenhuis M, Absorb Extend: an interim report on the 36-month clinical outcomes from the first 250 patients enrolled. Presented at Transcatheter Cardiovascular Therapeutics (TCT) conference 2014 in Washington, DC, September 2014</ref> Studies in real-world patients are ongoing.<ref name=smits2014 />
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| Imaging studies show that the Absorb naturally dissolving stent begins to dissolve from six to 12 months and is fully dissolved between two and three years after it is placed in the artery.<ref name=serruys2014 /> Two small platinum markers remain to mark the location of the original PCI. The artery is able to dilate and contract, called vasomotion, similar to a healthy blood vessel at two years.<ref name=serruys2009 />
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| ==References==
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| {{reflist}}
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| {{DEFAULTSORT:Bioresorbable Stents}}
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| [[Category:Cardiology]] | | [[Category:Cardiology]] |
| [[Category:Interventional cardiology]] | | [[Category:Biodegradable materials]] |
| [[Category:Implants (medicine)]]
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| {{dictionary-stub1}}
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| <gallery>
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| File:Bioresorbable stent.jpg|Bioresorbable stent
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| </gallery>
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A type of stent that is absorbed by the body after fulfilling its purpose
A bioresorbable stent implanted in a blood vessel
| Pronunciation | |
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| Other names | Bioabsorbable stent, biodegradable stent |
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| Medical specialty | Cardiology, Vascular surgery |
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| Approach | |
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| Other options | |
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A bioresorbable stent, also known as a bioresorbable vascular scaffold (BVS), is a type of stent used in interventional cardiology to treat narrowed or blocked coronary arteries. Unlike traditional metal stents, bioresorbable stents are designed to be absorbed by the body over time, leaving behind a natural vessel.
Design and Composition[edit]
Bioresorbable stents are typically made from materials such as polylactic acid (PLA) or poly-L-lactic acid (PLLA), which are biodegradable polymers. These materials are chosen for their ability to provide temporary support to the artery while gradually dissolving into naturally occurring substances in the body, such as carbon dioxide and water.
Mechanism of Action[edit]
The primary function of a bioresorbable stent is to provide mechanical support to a narrowed artery, allowing it to remain open and restore adequate blood flow. Over time, as the artery heals and remodels, the stent is absorbed by the body, reducing the risk of long-term complications associated with permanent stents, such as stent thrombosis and in-stent restenosis.
Advantages[edit]
Bioresorbable stents offer several potential advantages over traditional stents:
- Reduced Long-term Complications: By being absorbed, they eliminate the risk of late stent thrombosis and reduce the incidence of restenosis.
- Restoration of Natural Vessel Function: Once absorbed, the vessel can regain its natural vasomotion and flexibility.
- Improved Imaging: The absence of a permanent metallic structure allows for better imaging with non-invasive imaging techniques such as MRI.
Challenges and Limitations[edit]
Despite their advantages, bioresorbable stents face several challenges:
- Thicker Struts: To provide adequate support, bioresorbable stents often have thicker struts compared to metallic stents, which can affect deliverability and increase the risk of early thrombosis.
- Longer Absorption Time: The complete absorption process can take several years, during which time the risk of complications remains.
- Limited Data: Long-term data on the safety and efficacy of bioresorbable stents is still being collected, and their use is not yet as widespread as traditional stents.
Current Use and Research[edit]
Bioresorbable stents are currently used in select patients and are the subject of ongoing research to improve their design and performance. Studies are focused on optimizing the materials used, reducing strut thickness, and enhancing the drug-eluting capabilities of these stents to improve outcomes.
Related pages[edit]
