Experimental and Computational Study of Mechanical and Transport Properties of a Polymer Coating for drug-eluting Stents

References

• Gogas BD McDaniel M Samady H King SB 3rd . Novel drug-eluting stents for coronary revascularization. Trends Cardiovasc. Med.24 (7), 305–313 (2014).
   PubMed Web of Science ®Google Scholar
• US Department of Health and Human Services, FDA, Center for Devices and Radiological Health . Guidance for Industry and FDA Staff–Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems.www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm071863.htm
   Google Scholar
• Gershlick A De Scheerder I Chevalier B et al. Inhibition of restenosis with a paclitaxel-eluting, polymer-free coronary stent: the European evaLUation of pacliTaxel Eluting Stent (ELUTES) trial. Circulation109, 487–493 (2004).
   PubMed Web of Science ®Google Scholar
• Park SJ Shim WH Ho DS et al. A paclitaxel-eluting stent for the prevention of coronary restenosis. N. Engl. J. Med.348, 1537–1545 (2003).
   PubMed Web of Science ®Google Scholar
• Calderas C Condado JF Condado JA et al. Safety and efficacy of low-dose paclitaxel utilizing the cobra-P drug-eluting stent system with a novel biodegradable coating in de novo coronary lesions: the PLUS-ONE first-in-man study. Cardiovasc. Revasc. Med.15 (1), 18–22 (2014).
   PubMedGoogle Scholar
• Kirtane AJ Leon MB Ball MW et al. The “final” 5-year follow-up from the ENDEAVOR IV trial comparing a zotarolimus-eluting stent with a paclitaxel-eluting stent. JACC Cardiovasc. Interv.6 (4), 325–333 (2013).
   PubMed Web of Science ®Google Scholar
• Grube E Schofer J Hauptmann KE et al. A novel paclitaxel-eluting stent with an ultrathin abluminal biodegradable polymer 9-month outcomes with the JACTAX HD stent. JACC Cardiovasc. Interv.3 (4), 431–438 (2010).
   PubMed Web of Science ®Google Scholar
• Allocco DJ Cannon LA Britt A et al. A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: design and statistical methods of the PERSEUS clinical program. Trials11, 1 (2010).
   PubMed Web of Science ®Google Scholar
• Migliavacca F Petrini L Montanari V Quagliana I Auricchio F Dubini G . A predictive study of the mechanical behaviour of coronary stents by computer modelling. Med. Eng. Phys.27, 13–18 (2005).
   PubMed Web of Science ®Google Scholar
• De Beule M Van Impe R Verhegghe B et al. Finite element analysis and stent design: reduction of dogboning. Technol. Health Care14, 233–241 (2006).
   PubMedGoogle Scholar
• Wang WQ Liang DK Yang DZ Qi M . Analysis of the transient expansion behavior and design optimization of coronary stents by finite element method. J. Biomech.39, 21–32 (2006).
   PubMed Web of Science ®Google Scholar
• Pant S Limbert G Curzen NP Bressloff NW . Multiobjective design optimisation of coronary stents. Biomaterials32 (31), 7755–7773 (2011).
   PubMed Web of Science ®Google Scholar
• Gervaso F Capelli C Petrini L Lattanzio S Di Virgilio L Migliavacca F . On the effects of different strategies in modelling balloon-expandable stenting by means of finite element method. J. Biomech.1, 1206–1212 (2008).
   Google Scholar
• Conway C McGarry JP McHugh PE . Modelling of atherosclerotic plaque for use in a computational test-bed for stent angioplasty. Ann. Biomed. Eng.42 (12), 2425–2439 (2014).
   PubMed Web of Science ®Google Scholar
• Pericevic I Lally C Toner D Kelly DJ . The influence of plaque composition on underlying arterial wall stress during stent expansion: the case for lesion-specific stents. Med. Eng. Phys.31 (4), 428–433 (2009).
   PubMed Web of Science ®Google Scholar
• Gijsen FJ Migliavacca F Schievano S et al. Simulation of stent deployment in a realistic human coronary artery. Biomed. Eng. Online7, 23 (2008).
   PubMed Web of Science ®Google Scholar
• Zahedmanesh H John Kelly D Lally C . Simulation of a balloon expandable stent in a realistic coronary artery–determination of the optimum modelling strategy. J. Biomech.43 (11), 2126–2132 (2010).
   PubMed Web of Science ®Google Scholar
• Capelli C Gervaso F Petrini L Dubini G Migliavacca F . Assessment of tissue prolapse after balloon-expandable stenting: influence of stent cell geometry. Med. Eng. Phys.31 (4), 441–447 (2009).
   PubMed Web of Science ®Google Scholar
• Balossino R Gervaso F Migliavacca F Dubini G . Effects of different stent designs on local hemodynamics in stented arteries. J. Biomech.41, 1053–1061 (2008).
   PubMed Web of Science ®Google Scholar
• Zunino P D’Angelo C Petrini L Vergara C Cappelli C Migliavacca F . Numerical simulation of drug eluting coronary stents: mechanics, fluid dynamics and drug release. Comput. Methods Appl. Mech. Eng.198, 3633–3644 (2009).
   Web of Science ®Google Scholar
• Vairo G Cioffi M Cottone R Dubini G Migliavacca F . Drug release from coronary eluting stents: a multidomain approach. J. Biomech.43, 1580–1589 (2010).
   PubMed Web of Science ®Google Scholar
• Kolandaivelu K Leiden BB Edelman ER . Predicting response to endovascular therapies: dissecting the roles of local lesion complexity, systemic comorbidity, and clinical uncertainty. J. Biomech.47 (4), 908–921 (2014).
   PubMed Web of Science ®Google Scholar
• Morlacchi S Migliavacca F . Modeling stented coronary arteries: where we are, where to go. Ann. Biomed. Eng.41 (7), 1428–1444 (2013).
   PubMed Web of Science ®Google Scholar
• Lee S Lee CW Kim CS . FEA study on the stress distributions in the polymer coatings of cardiovascular drug-eluting stent medical devices. Ann. Biomed. Eng.42 (9), 1952–1965 (2014).
   PubMed Web of Science ®Google Scholar
• Silvestri D Gagliardi M Cristallini C Barbani N Giusti P . Different composition poly(methyl methacrylate-co-butyl methacrylate) copolymers through seeded semi-batch emulsion polymerization. Polym. Bull.63, 423–439 (2009).
   Web of Science ®Google Scholar
• US Department of Health and Human Services, FDA . Guidance for industry: dissolution testing of immediate release solid oral dosage forms, office of training and communications, MD, USAA1–A2 (1997). www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070237.pdf
   Google Scholar
• Gagliardi M . Relevance of mesh dimension optimization, geometry simplification and discretization accuracy in the study of mechanical behaviour of bare metal stents. Int. J. Comput. Models Algorithms Med.1, 31–45 (2010).
   Google Scholar
• Xia Z Ju F Katsuhiko S . A general finite element analysis method for balloon expandable stents based on repeated unit cell (RUC) model. Finite Elem. Anal. Des.43 (8), 649–658 (2007).
   Web of Science ®Google Scholar
• Gao H Long Q Graves M Gillard JH Li ZY . Carotid arterial plaque stress analysis using fluid-structure interactive simulation based on in-vivo magnetic resonance images of four patients. J. Biomech.42 (10), 1416–1423 (2009).
   PubMed Web of Science ®Google Scholar
• Gao H Long Q Graves M Li ZY Gillard JH . Curvedness study on atherosclerosis plaques and its implications to plaque stress. 6th World Congress of Biomechanics (WCB 2010). 2010 Singapore IFMBE Proceedings31, 1507–1510 (2010). https://eprints.usq.edu.au/18535/2/1front-matter.pdf
   Google Scholar
• Hose DR Narracott AJ Griffiths B et al. A thermal analogy for modelling drug elution from cardiovascular stents. Comput. Methods Biomech. Biomed. Engin.7, 257–264 (2004).
   PubMedGoogle Scholar
• Feng J Zihui X Katsuhiko S . On the finite element modelling of balloon-expandable stents. J. Mech. Behav. Biomed. Mater.1 (1), 86–95 (2008).
   PubMed Web of Science ®Google Scholar
• Li ZY Howarth SP Tang T et al. Structural analysis and magnetic resonance imaging predict plaque vulnerability: a study comparing symptomatic and asymptomatic individuals. J. Vasc. Surg.45 (4), 768–775 (2007).
   PubMed Web of Science ®Google Scholar
• Imani M Goudarzi AM Hojjati MH . Finite element analysis of mechanical behaviors of multi-link stent in a coronary artery with plaque. World. Appl. Sci. J.21 (11), 1597–1602 (2013).
   Google Scholar
• Lovich MA Creel CJ Hong K . Carrier proteins determine local pharmacokinetics and arterial distribution of Paclitaxel. J. Pharm. Sci.90, 1324–1335 (2001).
   PubMed Web of Science ®Google Scholar
• Hwang CW Levin AD Jonas M Li PH Edelman ER . Thrombosis modulates arterial drug distribution for drug-eluting stents. Circulation111, 1619–1626 (2005).
   PubMed Web of Science ®Google Scholar
• Ji J Kobayashi S Morikawa H Morikawa H Tang D Ku DN . Diastolic predominant flow in compliant coronary stenosis model. J. Biomech. Sci. Eng.5, 303–313 (2010).
   Google Scholar
• Vaclavikova R Soucek P Svobodova L et al. Different in vitro metabolism of paclitaxel and docetaxel in humans, rats, pigs, and minipigs. Drug. Metab. Dispos.32, 666–674 (2004).
   PubMed Web of Science ®Google Scholar
• Joner M Nakazawa G Finn AV et al. Endothelial cell recovery between comparator polymer-based drug-eluting stents. J. Am. Coll. Cardiol.52 (5), 333–342 (2008).
   PubMed Web of Science ®Google Scholar
• Tomić SL Mićić MM Filipović JM Suljovrujić EH . Swelling and drug release behavior of poly(2-hydroxyethyl methacrylate/itaconic acid) copolymeric hydrogels obtained by gamma irradiation. Rad. Phys. Chem.76, 801–810 (2007).
   Web of Science ®Google Scholar
• Gagliardi M Silvestri D Cristallini C . Macromolecular composition and drug-loading effect on the delivery of paclitaxel and folic acid from acrylic matrices. Drug Deliv.17, 452–465 (2010).
   PubMed Web of Science ®Google Scholar
• Litvinov VM . Diffusivity of water molecules in amorphous phase of nylon-6 fiber. Macromolecules48, 4748–4753 (2015).
   Web of Science ®Google Scholar
• Gagliardi M . On the effect of macromolecular composition and drug loading on thermal and tensile mechanical properties of methyl methacrylate and butyl methacrylate copolymers. Polym. Bull.71, 533–544 (2014).
   Web of Science ®Google Scholar
• Gagliardi M . In vitro haematic proteins adsorption and cytocompatibility study on acrylic copolymer to realise coatings for drug-eluting stents. Mater. Sci. Eng. C32, 2445–2451 (2012).
   Web of Science ®Google Scholar
• Schurtz G Delhaye C Hurt C Thieuleux H Lemesle G . Biodegradable polymer biolimus-eluting stent (Nobori®) for the treatment of coronary artery lesions: review of concept and clinical results. Med. Devices (Auckl.)7, 35–43 (2014).
   PubMedGoogle Scholar
• Puskas JE Munoz-Robledo LG Hoerr RA et al. Drug-eluting stent coatings. Wiley Interdiscip. Rev. Nanomed. Nanobiotechnol.1 (4), 451–462 (2009).
   PubMed Web of Science ®Google Scholar
• Navarese EP Kowalewski M Kandzari D et al. First-generation versus second-generation drug-eluting stents in current clinical practice: updated evidence from a comprehensive meta-analysis of randomised clinical trials comprising 31 379 patients. Open Heart1, doi: 10.1136/openhrt-2014-000064 (2014) ( Epub ahead of print).
   PubMedGoogle Scholar
• Machado C Raposo L Dores H et al. Second-generation versus first-generation drug-eluting stents for the treatment of patients with acute coronary syndromes and obstructive coronary artery disease. Coron Artery Dis.25 (3), 208–214 (2014).
   PubMed Web of Science ®Google Scholar
• Akin I Schneider H Ince H et al. Second- and third-generation drug-eluting coronary stents: progress and safety. Herz36 (3), 190–196 (2011).
   PubMed Web of Science ®Google Scholar
• Kang SH Park KW Kang DY et al. Biodegradable-polymer drug-eluting stents vs. bare metal stents vs. durable-polymer drug-eluting stents: a systematic review and Bayesian approach network meta-analysis. Eur. Heart J.35 (17), 1147–1158 (2014).
   PubMed Web of Science ®Google Scholar
• Palmerini T Biondi-Zoccai G Della Riva D et al. Clinical outcomes with bioabsorbable polymer- versus durable polymer-based drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J. Am. Coll. Cardiol.63 (4), 299–307 (2014).
   PubMed Web of Science ®Google Scholar
• Bangalore S Toklu B Amoroso N et al. Bare metal stents, durable polymer drug eluting stents, and biodegradable polymer drug eluting stents for coronary artery disease: mixed treatment comparison meta-analysis. BMJ347, f6625 (2013).
   PubMed Web of Science ®Google Scholar
• O’Brien B Zafar H Ibrahim A Zafar J Sharif F . Coronary stent materials and coatings: a technology and performance update. Ann. Biomed. Eng. doi:10.1007/s10439-015-1380-x (2015) ( Epub ahead of print).
   PubMed Web of Science ®Google Scholar