Optimization of drug delivery by drug-eluting stents

PLoS ONE

Volumn 10, Issue 6, 2015, Pages

  Bozsak, Franz ^a   Gonzalez Rodriguez, David ^a   Sternberger, Zachary ^a   Belitz, Paul ^b   Bewley, Thomas ^b   Chomaz, Jean Marc ^a   Barakat, Abdul I ^a  

^a ECOLE POLYTECHNIQUE   (France)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PACLITAXEL; RAPAMYCIN;

ARTERY MEDIA; ARTICLE; CONTROLLED STUDY; DRUG BINDING; DRUG CONCENTRATION; DRUG DELIVERY SYSTEM; DRUG ELUTING STENT; DRUG RELEASE; DRUG RETENTION; DRUG TRANSPORT; EQUIPMENT DESIGN; FLUID FLOW; MATERIAL COATING; MATHEMATICAL MODEL; PACLITAXEL ELUTING STENT; PROCESS OPTIMIZATION; SIROLIMUS ELUTING STENT; SUBENDOTHELIUM CELL; TIME; TRANSPORT KINETICS; ADVERSE EFFECTS; ALGORITHM; ATHEROSCLEROSIS; BIOLOGICAL MODEL; CONSTRICTION, PATHOLOGIC; METABOLISM; PATHOPHYSIOLOGY; PROCEDURES; PROSTHESIS DESIGN; TRANSPORT AT THE CELLULAR LEVEL; TUNICA MEDIA; VASCULAR ENDOTHELIUM; WOUND HEALING;

ALGORITHMS; ATHEROSCLEROSIS; BIOLOGICAL TRANSPORT; CONSTRICTION, PATHOLOGIC; DRUG DELIVERY SYSTEMS; DRUG-ELUTING STENTS; ENDOTHELIUM, VASCULAR; MODELS, BIOLOGICAL; PACLITAXEL; PROSTHESIS DESIGN; TUNICA MEDIA; WOUND HEALING;

EID: 84939174725     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0130182     Document Type: Article

References (84)

1. Räber L, Wohlwend L, Wigger M, Togni M, Wandel S, Wenaweser P, et al. (2011) Five-year clinical and angiographic outcomes of a randomized comparison of sirolimus-eluting and paclitaxel-eluting stents/clinical perspective. Circulation 123: 2819-2828. doi: 10.1161/CIRCULATIONAHA.110.004762 PMID: 21646500
2. Buchanan GL, Basavarajaiah S, Chieffo A (2012) Stent thrombosis: Incidence, predictors and new technologies. Thrombosis 2012: 1-12. doi: 10.1155/2012/956962
3. Birkmeier KA, Kastrati A, Byrne RA, Holle H, Schulz S, Tiroch K, et al. (2011) Five-year clinical outcomes of sirolimus-eluting versus paclitaxel-eluting stents in high-risk patients. Catheterization and Cardiovascular Interventions 77: 494-501. doi: 10.1002/ccd.22757 PMID: 20824758
4. Sakai S, Mizuno K, Yokoyama S, Tanabe J, Shinada T, Seimiya K, et al. (2003) Morphologic changes in infarct-related plaque after coronary stent placement: A serial angioscopy study. Journal of the American College of Cardiology 42: 1558-1565. doi: 10.1016/j.jacc.2003.06.003 PMID: 14607438
5. Ueda Y, Nanto S, Komamura K, Kodama K (1994) Neointimal coverage of stents in human coronary arteries observed by angioscopy. Journal of the American College of Cardiology 23: 341-346. doi: 10. 1016/0735-1097(94)90417-0 PMID: 8294684
6. Lüscher TF, Steffel J, Eberli FR, Joner M, Nakazawa G, Tanner FC, et al. (2007) Drug-eluting stent and coronary thrombosis: Biological mechanisms and clinical implications. Circulation 115: 1051-1058. doi: 10.1161/CIRCULATIONAHA.106.675934 PMID: 17325255
7. Liuzzo JP, Ambrose JA, Coppola JT (2005) Sirolimus-and taxol-eluting stents differ towards intimal hyperplasia and re-endothelialization. The Journal of Invasive Cardiology 17: 497-502. PMID: 16145242
8. Finn AV, Nakazawa G, Joner M, Kolodgie FD, Mont EK, Gold HK, et al. (2007) Vascular responses to drug eluting stents: Importance of delayed healing. Arteriosclerosis, Thrombosis, and Vascular Biology 27: 1500-1510. doi: 10.1161/ATVBAHA.107.144220 PMID: 17510464
9. Li H, Zhang Lj, Chen Bh, Zhou X, Su K, Shi Wt, et al. (2010) Inhibitory effect of paclitaxel on endothelial cell adhesion and migration. Pharmacology 85: 136-145. doi: 10.1159/000280587 PMID: 20145425
10. Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, et al. (2007) Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: Data from a large two-institutional cohort study. The Lancet 369: 667-678. doi: 10.1016/S0140-6736(07) 60314-6
11. Bozsak F, Chomaz JM, Barakat AI (2014) Modeling the transport of drugs eluted from stents: Physical phenomena driving drug distribution in the arterial wall. Biomechanics and Modeling in Mechanobiology 13: 327-347. doi: 10.1007/s10237-013-0546-4 PMID: 24395527
12. Atherton MA, Bates RA (2004) Robust optimization of cardiovascular stents: A comparison of methods. Engineering Optimization 36: 207-217. doi: 10.1080/03052150310001639290
13. Srinivas K, Nakayama T, Ohta M, Obayashi S, Yamaguchi T (2008) Studies on design optimization of coronary stents. Journal of Medical Devices 2: 011004. doi: 10.1115/1.2885145
14. Gundert TJ, Marsden AL, Yang W, LaDisa JF (2012) Optimization of cardiovascular stent design using computational fluid dynamics. Journal of Biomechanical Engineering 134: 011002. doi: 10.1115/1. 4005542 PMID: 22482657
15. Gundert TJ, Marsden AL, Yang W, Marks DS, LaDisa JF (2012) Identification of hemodynamically optimal coronary stent designs based on vessel caliber. IEEE Transactions on Biomedical Engineering 59: 1992-2002. doi: 10.1109/TBME.2012.2196275 PMID: 22547450
16. Wu W, Petrini L, Gastaldi D, Villa T, Vedani M, Lesma E, et al. (2010) Finite element shape optimization for biodegradable magnesium alloy stents. Annals of Biomedical Engineering 38: 2829-2840. doi: 10. 1007/s10439-010-0057-8 PMID: 20446037
17. Timmins L, Moreno M, Meyer C, Criscione J, Rachev A, Moore J (2007) Stented artery biomechanics and device design optimization. Medical and Biological Engineering and Computing 45: 505-513. doi: 10.1007/s11517-007-0180-3 PMID: 17375345
18. Pant S, Limbert G, Curzen N, Bressloff N (2011) Multiobjective design optimisation of coronary stents. Biomaterials 32: 7755-7773. doi: 10.1016/j.biomaterials.2011.07.059 PMID: 21821283
19. Pant S, Bressloff N, Limbert G (2012) Geometry parameterization and multidisciplinary constrained optimization of coronary stents. Biomechanics and Modeling in Mechanobiology 11: 61-82. doi: 10.1007/s10237-011-0293-3 PMID: 21373889
20. Jones DR (2001) A taxonomy of global optimization methods based on response surfaces. Journal of Global Optimization 21: 345-383. doi: 10.1023/A: 1012771025575
21. Grogan JA, Leen SB, McHugh PE (2013) Optimizing the design of a bioabsorbable metal stent using computer simulation methods. Biomaterials 34: 8049-8060. doi: 10.1016/j.biomaterials.2013.07.010 PMID: 23906516
22. Aragon J, Kar S, Tio F, Trauthen B, Parisky A, Watanabe C, et al. (2005) The effect of variable release kinetics on paclitaxel efficacy from a drug eluting stent in a porcine model. EuroIntervention 1: 228-235. PMID: 19758908
23. Lao LL, Venkatraman SS (2008) Adjustable paclitaxel release kinetics and its efficacy to inhibit smooth muscle cells proliferation. Journal of Controlled Release 130: 9-14. doi: 10.1016/j.jconrel.2008.05.008 PMID: 18599145
24. Frey D, Billinger M, Meier P, Beslac O, Grossenbacher R, Hänni B, et al. (2008) Endothelialization of sirolimus-eluting stents with slow and extended drug release in the porcine overstretch model. The Journal of Invasive Cardiology 20: 631-634. PMID: 19057024
25. Pan CJ, Tang JJ, Weng YJ, Wang J, Huang N (2009) Preparation and in vitro release profiles of drugeluting controlled biodegradable polymer coating stents. Colloids and Surfaces B: Biointerfaces 73: 199-206. doi: 10.1016/j.colsurfb.2009.05.016 PMID: 19541460
26. Guagliumi G, Ikejima H, Sirbu V, Bezerra H, Musumeci G, Lortkipanidze N, et al. (2011) Impact of drug release kinetics on vascular response to different zotarolimus-eluting stents implanted in patients with long coronary stenoses: The LongOCT study (optical coherence tomography in long lesions). JACC: Cardiovascular Interventions 4: 778-785. doi: 10.1016/j.jcin.2011.04.007 PMID: 21777886
27. Balakrishnan B, Dooley JF, Kopia G, Edelman ER (2007) Intravascular drug release kinetics dictate arterial drug deposition, retention, and distribution. Journal of Controlled Release 123: 100-108. doi: 10. 1016/j.jconrel.2007.06.025 PMID: 17868948
28. Tzafriri AR, Groothuis A, Price GS, Edelman ER (2012) Stent elution rate determines drug deposition and receptor-mediated effects. Journal of Controlled Release 161: 918-926. doi: 10.1016/j.jconrel. 2012.05.039 PMID: 22642931
29. Venkatraman S, Boey F (2007) Release profiles in drug-eluting stents: Issues and uncertainties. Journal of Controlled Release 120: 149-160. doi: 10.1016/j.jconrel.2007.04.022 PMID: 17582635
30. Tesfamariam B (2008) Drug release kinetics from stent device-based delivery systems. Journal of Cardiovascular Pharmacology 51: 118-125. doi: 10.1097/FJC.0b013e318158540f PMID: 18287878
31. Belitz P (2011) Applications on Multi-Dimensional Sphere Packings: Derivative-Free Optimization. Ph. D. thesis, University of California at San Diego.
32. Belitz P, Bewley T (2012) New horizons in sphere-packing theory, part II: Lattice-based derivative-free optimization via global surrogates. Journal of Global Optimization: 1-31.
33. Tzafriri AR, Levin AD, Edelman ER (2009) Diffusion-limited binding explains binary dose response for local arterial and tumour drug delivery. Cell Proliferation 42: 348-363. doi: 10.1111/j.1365-2184.2009. 00602.x PMID: 19438899
34. Garg S, Serruys PW (2010) Coronary stents: Current status. Journal of the American College of Cardiology 56: S1-S42. doi: 10.1016/j.jacc.2010.06.007 PMID: 20797502
35. Lusis AJ (2000) Atherosclerosis. Nature 407: 233-241. doi: 10.1038/35025203 PMID: 11001066
36. Libby P (2002) Inflammation in atherosclerosis. Nature 420: 868-874. doi: 10.1038/nature01323 PMID: 12490960
37. Huang ZJ, Tarbell JM (1997) Numerical simulation of mass transfer in porous media of blood vessel walls. Advanced Drug Delivery Reviews 273: H464-H477.
38. Hindmarsh AC, Brown PN (2005). SUNDIALS: Suite of nonlinear and Differential/Algebraic equation solvers.
39. AIAA (1998) AIAA Guide for the Verification and Validation of Computational Fluid Dynamics Simulations. American Institute of Aeronautics & Astronautics.
40. Vergara C, Zunino P (2008) Multiscale boundary conditions for drug release from cardiovascular stents. Multiscale Modeling & Simulation 7: 565-588. doi: 10.1137/07070214X
41. Siepmann J, Peppas NA (2011) Higuchi equation: Derivation, applications, use and misuse. International Journal of Pharmaceutics 418: 6-12. doi: 10.1016/j.ijpharm.2011.03.051 PMID: 21458553
42. Guagliumi G, Sirbu V, Musumeci G, Gerber R, Biondi-Zoccai G, Ikejima H, et al. (2012) Examination of the in vivo mechanisms of late drug-eluting stent thrombosis: Findings from optical coherence tomography and intravascular ultrasound imaging. JACC: Cardiovascular Interventions 5: 12-20. doi: 10.1016/j.jcin.2011.09.018 PMID: 22230145
43. Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, et al. (2007) Pathological correlates of late drug-eluting stent thrombosis. Circulation 115: 2435-2441. doi: 10.1161/CIRCULATIONAHA.107. 693739 PMID: 17438147
44. Kamath KR, Barry JJ, Miller KM (2006) The taxus(TM) drug-eluting stent: A new paradigm in controlled drug delivery. Advanced Drug Delivery Reviews 58: 412-436. doi: 10.1016/j.addr.2006.01.023 PMID: 16647782
45. McGinty S, McKee S, Wadsworth RM, McCormick C (2011) Modelling drug-eluting stents. Mathematical Medicine and Biology 28: 1-29. doi: 10.1093/imammb/dqq003 PMID: 20413417
46. Toiyama Y, Inoue Y, Hiro J, Ojima E, Watanabe H, Narita Y, et al. (2006) The range of optimal concentration and mechanisms of paclitaxel in radio-enhancement in gastrointestinal cancer cell lines. Cancer Chemotherapy and Pharmacology 59: 733-742. doi: 10.1007/s00280-006-0327-1 PMID: 16957932
47. Axel DI, Kunert W, Goggelmann C, Oberhoff M, Herdeg C, Kuttner A, et al. (1997) Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation 96: 636-645. doi: 10.1161/01.CIR.96.2.636 PMID: 9244237
48. Poon M, Marx SO, Gallo R, Badimon JJ, Taubman MB, Marks AR (1996) Rapamycin inhibits vascular smooth muscle cell migration. Journal of Clinical Investigation 98: 2277-2283. doi: 10.1172/JCI119038 PMID: 8941644
49. Matter CM, Rozenberg I, Jaschko A, Greutert H, Kurz DJ, Wnendt S, et al. (2006) Effects of tacrolimus or sirolimus on proliferation of vascular smooth muscle and endothelial cells. Journal of Cardiovascular Pharmacology 48: 286-292. doi: 10.1097/01.fjc.0000248233.22570.8b PMID: 17204907
50. Sun J, Marx SO, Chen HJ, Poon M, Marks AR, Rabbani LE (2001) Role for p27kip1 in vascular smooth muscle cell migration. Circulation 103: 2967-2972. doi: 10.1161/01.CIR.103.24.2967 PMID: 11413088
51. Inoue K (2012) Pathological perspective of drug-eluting stent thrombosis. Thrombosis 2012: 1-8. doi: 10.1155/2012/219389
52. Wessely R, Blaich B, Belaiba RS, Merl S, Görlach A, Kastrati A, et al. (2007) Comparative characterization of cellular and molecular anti-restenotic profiles of paclitaxel and sirolimus. implications for local drug delivery. Thrombosis and Haemostasis 97: 1003-1012.
53. R EE, Rogers C (1998) Pathobiologic responses to stenting. The American Journal of Cardiology 81: 4E-6E. doi: 10.1016/S0002-9149(98)00189-1
54. Klugherz BD, Llanos G, Lieuallen W, Kopia GA, Papandreou G, Narayan P, et al. (2002) Twenty-eightday efficacy and phamacokinetics of the sirolimus-eluting stent. Coronary Artery Disease 13: 183-188. doi: 10.1097/00019501-200205000-00008 PMID: 12131023
55. Marx SO, Totary-Jain H, Marks AR (2011) Vascular smooth muscle cell proliferation in restenosis. Circulation: Cardiovascular Interventions 4: 104-111.
56. Acharya G, Park K (2006) Mechanisms of controlled drug release from drug-eluting stents. Advanced Drug Delivery Reviews 58: 387-401. doi: 10.1016/j.addr.2006.01.016 PMID: 16546289
57. Booker AJ, Dennis JE, Frank PD, Serafini DB, Torczon V, TrossetMW(1999) A rigorous framework for optimization of expensive functions by surrogates. Structural Optimization 17: 1-13. doi: 10.1007/BF01197708
58. Krige D (1951) A statistical approach to some basic mine valuation problems on the witwatersrand. Journal of the Chemical, Metallurgical and Mining Society of South Africa 52: 119-139.
59. Matheron G (1963) Principles of geostatistics. Economic Geology 58: 1246-1266. doi: 10.2113/gsecongeo.58.8.1246
60. Forrester AIJ, Sóbester A, Keane AJ (2008) Engineering design via surrogate modelling a practical guide. J. Wiley.
61. Marsden AL, Wang M, Dennis JE, Moin P (2004) Optimal aeroacoustic shape design using the surrogate management framework. Optimization and Engineering 5: 235-262. doi: 10.1023/B: OPTE. 0000033376.89159.65
62. Marsden AL, Wang M, Dennis JE, Moin P (2007) Trailing-edge noise reduction using derivative-free optimization and large-eddy simulation. Journal of Fluid Mechanics 572: 13. doi: 10.1017/S0022112006003235
63. Marsden AL, Feinstein JA, Taylor CA (2008) A computational framework for derivative-free optimization of cardiovascular geometries. Computer Methods in Applied Mechanics and Engineering 197: 1890-1905. doi: 10.1016/j.cma.2007.12.009
64. Yang W, Feinstein JA, Marsden AL (2010) Constrained optimization of an idealized y-shaped baffle for the fontan surgery at rest and exercise. Computer Methods in Applied Mechanics and Engineering 199: 2135-2149. doi: 10.1016/j.cma.2010.03.012
65. Sibson R (1981) A brief description of natural neighbor interpolation (chapter 2). In: Barnett V, editor, Interpreting multivariate data, Wiley, Wiley series in probability and mathematical statistics. pp. 21-36.
66. Radeleff B, Lopez-Benitez R, Stampfl U, Stampfl S, Sommer C, Thierjung H, et al. (2010) Paclitaxel-induced arterial wall toxicity and inflammation: Tissue uptake in various dose densities in a minipig model. Journal of Vascular and Interventional Radiology 21: 1262-1270. doi: 10.1016/j.jvir.2010.02. 020 PMID: 20656224
67. Lei L, Guo SR, Chen WL, Rong HJ, Lu F (2011) Stents as a platform for drug delivery. Expert Opinion on Drug Delivery 8: 813-831. doi: 10.1517/17425247.2011.572068 PMID: 21548713
68. Ielasi A, Latib A, Colombo A (2011) Current and future drug-eluting coronary stent technology. Expert Review of Cardiovascular Therapy 9: 485-503. doi: 10.1586/erc.11.5 PMID: 21517732
69. van Beusekom HM, Saia F, Zindler JD, Lemos PA, Swager-ten Hoor SL, de Feijter PJ, et al. (2007) Drug-eluting stents show delayed healing: Paclitaxel more pronounced than sirolimus. European Heart Journal 28: 974-979. doi: 10.1093/eurheartj/ehm064 PMID: 17434882
70. Farhan S, Hemetsberger R, Matiasek J, Strehblow C, Pavo N, Khorsand A, et al. (2009) Implantation of paclitaxel-eluting stent impairs the vascular compliance of arteries in porcine coronary stenting model. Atherosclerosis 202: 144-151. doi: 10.1016/j.atherosclerosis.2008.04.039 PMID: 18514201
71. Farb A, Heller PF, Shroff S, Cheng L, Kolodgie FD, Carter AJ, et al. (2001) Pathological analysis of local delivery of paclitaxel via a polymer-coated stent. Circulation 104: 473-479. doi: 10.1161/hc3001. 092037 PMID: 11468212
72. Davies MJ, Richardson PD, Woolf N, Katz DR, Mann J (1993) Risk of thrombosis in human atherosclerotic plaques: Role of extracellular lipid, macrophage, and smooth muscle cell content. British Heart Journal 69: 377-381. doi: 10.1136/hrt.69.5.377 PMID: 8518056
73. Lopez-Candales A, Holmes DR, Liao S, Scott MJ, Wickline SA, Thompson RW (1997) Decreased vascular smooth muscle cell density in medial degeneration of human abdominal aortic aneurysms. The American Journal of Pathology 150: 993-1007. PMID: 9060837
74. Gray WA, Granada JF (2010) Drug-coated balloons for the prevention of vascular restenosis. Circulation 121: 2672-2680. doi: 10.1161/CIRCULATIONAHA.110.936922 PMID: 20566965
75. Kaul U, Mansoor AH (2012) Choice of drug-eluting stent-evidence-based or empirical. Journal of Indian College of Cardiology 2: 22-28. doi: 10.1016/S1561-8811(12)80005-8
76. Li S, Wang Y, Gai L, Yang T, Liu H, Wang Z, et al. (2013) Evaluation of neointimal coverage and apposition with various drug-eluting stents over 12 months after implantation by optical coherence tomography. International Journal of Cardiology 162: 166-171. doi: 10.1016/j.ijcard.2011.05.076 PMID: 21641053
77. Garg S, Serruys PW (2010) Coronary stents: Looking forward. Journal of the American College of Cardiology 56: S43-S78. doi: 10.1016/j.jacc.2010.06.007 PMID: 20797503
78. Garg S, Magro M, Serruys P (2011) 6.627-drug-eluting stents. In: Ducheyne P, editor, Comprehensive Biomaterials, Elsevier. pp. 427-448.
79. Abizaid A (2007) Sirolimus-eluting coronary stents: A review. Vascular Health and Risk Management 3: 191-201. doi: 10.2147/vhrm.2007.3.2.191 PMID: 17580729
80. Smits PC, Kedhi E, Royaards KJ, Joesoef KS, Wassing J, Rademaker-Havinga T, et al. (2011) 2-year follow-up of a randomized controlled trial of everolimus-and paclitaxel-eluting stents for coronary revascularization in daily practice. Journal of the American College of Cardiology 58: 11-18. doi: 10.1016/j. jacc.2011.02.023 PMID: 21514083
81. Stone GW, Rizvi A, Sudhir K, Newman W, Applegate RJ, Cannon LA, et al. (2011) Randomized comparison of everolimus-and paclitaxel-eluting stents2-year follow-up from the SPIRIT (clinical evaluation of the XIENCE v everolimus eluting coronary stent system) IV trial. Journal of the American College of Cardiology 58: 19-25. doi: 10.1016/j.jacc.2011.02.022 PMID: 21514084
82. Alfonso F, Pérez-Vizcayno MJ (2013) Drug-eluting balloons for restenosis after stent implantation. The Lancet 381: 431-433. doi: 10.1016/S0140-6736(12)62120-5
83. Cortese B, Sgueglia GA, Granada JF (2013) Paclitaxel coated balloons, the time for awareness has come. International Journal of Cardiology 164: 1-2. doi: 10.1016/j.ijcard.2012.05.037 PMID: 22658568
84. Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, et al. (2006) Treatment of coronary instent restenosis with a paclitaxel-coated balloon catheter. New England Journal of Medicine 355: 2113-2124. doi: 10.1056/NEJMoa061254 PMID: 17101615