Drug-Eluting Stents

  • Wahid Khan
  • Rajesh Thipparaboina
  • Shady Farah
  • Judah Z. Weinberger
  • Abraham J. Domb
Chapter
Part of the Advances in Delivery Science and Technology book series (ADST)

Abstract

Advances in the field of stents have revolutionised the treatment of coronary artery diseases. To provide effective treatment for coronary artery disease, a stent has to be deliverable and flexible, cause minimal trauma to the vessel wall, cause minimal inflammatory reaction, endothelialise well, provide scaffolding for the vessel, and finally promote vessel healing and remodelling. Bare-metal stents (BMS) have been commonly used to treat symptomatic coronary artery disease during the past two decades, but long-term results have shown problems of in-stent restenosis (ISR) and stent thrombosis. Intensive work to overcome the problems of ISR has successfully led to the introduction of drug-eluting stents (DES). DES has significantly reduced the rate of restenosis; it has reduced morbidity, mortality, and economic costs associated with the percutaneous treatment of coronary artery disease. Patients no longer have to come back for catheterisations due to ISR. The success of DES has shifted the focus on further developments towards enhancing long-term safety and efficacy of these devices. Bioabsorbable and polymer-free stents hold promise as successors to the current generation of DES.

Keywords

Fatigue Chromium Cobalt Aspirin Paclitaxel 

References

  1. 1.
    Hirsch AT, Gotto AM Jr (2002) Undertreatment of dyslipidemia in peripheral arterial disease and other high-risk populations: an opportunity for cardiovascular disease reduction. Vasc Med 7:323–331PubMedCrossRefGoogle Scholar
  2. 2.
    Eggum JH, Howard SA, Goff RP, Iaizzo PA (2012) Imaging of a coronary artery stent implantation within an isolated human heart. J Cardiovasc Transl Res 5:73–74PubMedCrossRefGoogle Scholar
  3. 3.
    Rao SV, Califf RM, Kramer JM, Peterson ED, Gross TP, Pepine CJ et al (2008) Postmarket evaluation of breakthrough technologies. Am Heart J 156:201–208PubMedCrossRefGoogle Scholar
  4. 4.
    Martin DM, Boyle FJ (2011) Drug-eluting stents for coronary artery disease: a review. Med Eng Phys 33:148–163PubMedCrossRefGoogle Scholar
  5. 5.
    Butt M, Connolly D, Lip GY (2009) Drug-eluting stents: a comprehensive appraisal. Future Cardiol 5:141–157PubMedCrossRefGoogle Scholar
  6. 6.
    Alfonso F, Perez-Vizcayno MJ, Cruz A, Garcia J, Jimenez-Quevedo P, Escaned J et al (2009) Treatment of patients with in-stent restenosis. EuroIntervention 5(Suppl D):D70–D78PubMedGoogle Scholar
  7. 7.
    Wykrzykowska JJ, Onuma Y, Serruys PW (2009) Advances in stent drug delivery: the future is in bioabsorbable stents. Expert Opin Drug Deliv 6:113–126PubMedCrossRefGoogle Scholar
  8. 8.
    Mauri L, Silbaugh TS, Garg P, Wolf RE, Zelevinsky K, Lovett A et al (2008) Drug-eluting or bare-metal stents for acute myocardial infarction. N Engl J Med 359:1330–1342PubMedCrossRefGoogle Scholar
  9. 9.
    Stefanadis CI (2011) Are all drug-eluting stents the same? Hellenic J Cardiol 52:96PubMedGoogle Scholar
  10. 10.
    Akin I, Schneider H, Ince H, Kische S, Rehders TC, Chatterjee T et al (2011) Second- and third-generation drug-eluting coronary stents: progress and safety. Herz 36:190–196PubMedCrossRefGoogle Scholar
  11. 11.
    Doostzadeh J, Clark LN, Bezenek S, Pierson W, Sood PR, Sudhir K (2010) Recent progress in percutaneous coronary intervention: evolution of the drug-eluting stents, focus on the XIENCE V drug-eluting stent. Coron Artery Dis 21:46–56PubMedCrossRefGoogle Scholar
  12. 12.
    Sheiban I, Villata G, Bollati M, Sillano D, Lotrionte M, Biondi-Zoccai G (2008) Next-generation drug-eluting stents in coronary artery disease: focus on everolimus-eluting stent (Xience V). Vasc Health Risk Manag 4:31–38PubMedCentralPubMedCrossRefGoogle Scholar
  13. 13.
    Joner M, Nakazawa G, Finn AV, Quee SC, Coleman L, Acampado E et al (2008) Endothelial cell recovery between comparator polymer-based drug-eluting stents. J Am Coll Cardiol 52:333–342PubMedCrossRefGoogle Scholar
  14. 14.
    Lange RA, Hillis LD (2010) Second-generation drug-eluting coronary stents. N Engl J Med 362:1728–1730PubMedCrossRefGoogle Scholar
  15. 15.
    Lopez JJ, Keyes MJ, Nathan S, Piana R, Pencina M, Dhar G et al (2010) Rapid adoption of drug-eluting stents: clinical practices and outcomes from the early drug-eluting stent era. Am Heart J 160:767–774PubMedCrossRefGoogle Scholar
  16. 16.
    Kereiakes DJ, Cannon LA, Ormiston JA, Turco MA, Mann T, Mishkel GJ et al (2011) Propensity-matched patient-level comparison of the TAXUS Liberté and TAXUS element (ION) paclitaxel-eluting stents. Am J Cardiol 108:828–837PubMedCrossRefGoogle Scholar
  17. 17.
    Navarese EP, Kubica J, Castriota F, Gibson CM, De Luca G, Buffon A et al (2011) Safety and efficacy of biodegradable vs. durable polymer drug-eluting stents: evidence from a meta-analysis of randomised trials. EuroIntervention 7:985–994PubMedCrossRefGoogle Scholar
  18. 18.
    de la Torre Hernandez JM, Windecker S (2012) Very late stent thrombosis with newer drug-eluting stents: no longer an issue? Rev Esp Cardiol (Engl Ed) 65:595–598CrossRefGoogle Scholar
  19. 19.
    Garg S, Serruys PW (2010) Coronary stents: looking forward. J Am Coll Cardiol 56:S43–S78PubMedCrossRefGoogle Scholar
  20. 20.
    LaDisa JF, Olson LE, Hettrick DA, Warltier DC, Kersten JR, Pagel PS (2005) Axial stent strut angle influences wall shear stress after stent implantation: analysis using 3D computational fluid dynamics models of stent foreshortening. Biomed Eng Online 4:59PubMedCentralPubMedCrossRefGoogle Scholar
  21. 21.
    LaDisa JF, Olson LE, Guler I, Hettrick DA, Audi SH, Kersten JR et al (2004) Stent design properties and deployment ratio influence indexes of wall shear stress: a three-dimensional computational fluid dynamics investigation within a normal artery. J Appl Physiol 97:424–430PubMedCrossRefGoogle Scholar
  22. 22.
    Kolachalama VB, Tzafriri AR, Arifin DY, Edelman ER (2009) Luminal flow patterns dictate arterial drug deposition in stent-based delivery. J Control Release 133:24–30PubMedCentralPubMedCrossRefGoogle Scholar
  23. 23.
    Pant S, Limbert G, Curzen NP, Bressloff NW (2011) Multiobjective design optimisation of coronary stents. Biomaterials 32:7755–7773PubMedCrossRefGoogle Scholar
  24. 24.
    Colombo A, Stankovic G, Moses JW (2002) Selection of coronary stents. J Am Coll Cardiol 40:1021–1033PubMedCrossRefGoogle Scholar
  25. 25.
    Sketch MH, Ball M, Rutherford B, Popma JJ, Russell C, Kereiakes DJ (2005) Evaluation of the Medtronic (Driver) cobalt-chromium alloy coronary stent system. Am J Cardiol 95:8–12PubMedCrossRefGoogle Scholar
  26. 26.
    Patel MJ, Patel SS, Patel NS, Patel NM (2012) Current status and future prospects of drug eluting stents for restenosis. Acta Pharm 62:473–496PubMedCrossRefGoogle Scholar
  27. 27.
    Ako J, Bonneau HN, Honda Y, Fitzgerald PJ (2007) Design criteria for the ideal drug-eluting stent. Am J Cardiol 100:3M–9MPubMedCrossRefGoogle Scholar
  28. 28.
    Pendyala LK, Yin X, Li J, Chen JP, Chronos N, Hou D (2009) The first-generation drug-eluting stents and coronary endothelial dysfunction. JACC Cardiovasc Interv 2:1169–1177PubMedCrossRefGoogle Scholar
  29. 29.
    Puskas JE, Munoz-Robledo LG, Hoerr RA, Foley J, Schmidt SP, Evancho-Chapman M et al (2009) Drug-eluting stent coatings. Wiley Interdiscip Rev Nanomed Nanobiotechnol 1:451–462PubMedGoogle Scholar
  30. 30.
    Mrowietz C, Franke RP, Seyfert UT, Park JW, Jung F (2005) Haemocompatibility of polymer-coated stainless steel stents as compared to uncoated stents. Clin Hemorheol Microcirc 32:89–103PubMedGoogle Scholar
  31. 31.
    Matschke K, Tugtekin SM, Kappert U, Jung F, Park JW, Knaut M (2004) Do drug-eluting stents influence the spectrum of coronary artery bypass surgery? Herz 29:201–207PubMedCrossRefGoogle Scholar
  32. 32.
    Levy Y, Mandler D, Weinberger J, Domb AJ (2009) Evaluation of drug-eluting stents’ coating durability–clinical and regulatory implications. J Biomed Mater Res B Appl Biomater 91:441–451PubMedCrossRefGoogle Scholar
  33. 33.
    Parker T, Dave V, Falotico R (2011) Polymers for drug eluting stents. Curr Pharm Des 16:3978–3988CrossRefGoogle Scholar
  34. 34.
    Mani G, Feldman MD, Patel D, Agrawal CM (2007) Coronary stents: a materials perspective. Biomaterials 28:1689–1710PubMedCrossRefGoogle Scholar
  35. 35.
    Moore JE Jr (2009) Biomechanical issues in endovascular device design. J Endovasc Ther 16(Suppl 1):I1–I11PubMedCentralPubMedGoogle Scholar
  36. 36.
    Stone GW, Ellis SG, Cox DA, Hermiller J, O’Shaughnessy C, Mann JT et al (2004) A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 350:221–231PubMedCrossRefGoogle Scholar
  37. 37.
    van der Hoeven BL, Pires NM, Warda HM, Oemrawsingh PV, van Vlijmen BJ, Quax PH et al (2005) Drug-eluting stents: results, promises and problems. Int J Cardiol 99:9–17PubMedCrossRefGoogle Scholar
  38. 38.
    Deconinck E, Sohier J, De Scheerder I, Van den Mooter G (2008) Pharmaceutical aspects of drug eluting stents. J Pharm Sci 97:5047–5060PubMedCrossRefGoogle Scholar
  39. 39.
    Tamburino C, Capodanno D (2009) Evolution of stents: past, present and future. Expert Rev Cardiovasc Ther 7:443–446PubMedCrossRefGoogle Scholar
  40. 40.
    Burke SE, Kuntz RE, Schwartz LB (2006) Zotarolimus (ABT-578) eluting stents. Adv Drug Deliv Rev 58:437–446PubMedCrossRefGoogle Scholar
  41. 41.
    Wykrzykowska JJ, Raber L, de Vries T, Bressers M, Buszman P, Linke A et al (2009) Biolimus-eluting biodegradable polymer versus sirolimus-eluting permanent polymer stent performance in long lesions: results from the LEADERS multicentre trial substudy. EuroIntervention 5:310–317PubMedCrossRefGoogle Scholar
  42. 42.
    Grube E, Buellesfeld L (2006) BioMatrix Biolimus A9-eluting coronary stent: a next-generation drug-eluting stent for coronary artery disease. Expert Rev Med Devices 3:731–741PubMedCrossRefGoogle Scholar
  43. 43.
    Radke PW, Weber C, Kaiser A, Schober A, Hoffmann R (2004) Dexamethasone and restenosis after coronary stent implantation: new indication for an old drug? Curr Pharm Des 10:349–355PubMedCrossRefGoogle Scholar
  44. 44.
    Pesarini G, Ferrero V, Tomai F, Paloscia L, De Cesare N, Tamburino C et al (2009) Steroid-eluting stents in patients with acute coronary syndromes. Angiographic results of DESIRE: Dexamethasone-Eluting Stent Italian REgistry. J Invasive Cardiol 21:86–91PubMedGoogle Scholar
  45. 45.
    Pan CJ, Tang JJ, Weng YJ, Wang J, Huang N (2006) Preparation, characterization and anticoagulation of curcumin-eluting controlled biodegradable coating stents. J Control Release 116:42–49PubMedCrossRefGoogle Scholar
  46. 46.
    Grube E, Gerckens U, Muller R, Bullesfeld L (2002) Drug eluting stents: initial experiences. Z Kardiol 91(Suppl 3):44–48PubMedCrossRefGoogle Scholar
  47. 47.
    Yang J, Zeng Y, Zhang C, Chen YX, Yang Z, Li Y et al (2013) The prevention of restenosis in vivo with a VEGF gene and paclitaxel co-eluting stent. Biomaterials 34:1635–1643PubMedCrossRefGoogle Scholar
  48. 48.
    Teomim D, Fishbien I, Golomb G, Orloff L, Mayberg M, Domb AJ (1999) Perivascular delivery of heparin for the reduction of smooth muscle cell proliferation after endothelial injury. J Control Release 60:129–142PubMedCrossRefGoogle Scholar
  49. 49.
    Kavanagh CA, Rochev YA, Gallagher WM, Dawson KA, Keenan AK (2004) Local drug delivery in restenosis injury: thermoresponsive co-polymers as potential drug delivery systems. Pharmacol Ther 102:1–15PubMedCrossRefGoogle Scholar
  50. 50.
    Vorpahl M, Virmani R, Ladich E, Finn AV (2009) Vascular remodeling after coronary stent implantation. Minerva Cardioangiol 57:621–628PubMedGoogle Scholar
  51. 51.
    Park DW, Park SW, Park KH, Lee BK, Kim YH, Lee CW et al (2006) Frequency of and risk factors for stent thrombosis after drug-eluting stent implantation during long-term follow-up. Am J Cardiol 98:352–356PubMedCrossRefGoogle Scholar
  52. 52.
    Jeremias A, Kirtane A (2008) Balancing efficacy and safety of drug-eluting stents in patients undergoing percutaneous coronary intervention. Ann Intern Med 148:234–238PubMedCrossRefGoogle Scholar
  53. 53.
    Costa JR Jr, Abizaid A, Costa R, Feres F, Tanajura LF, Maldonado G et al (2009) 1-year results of the hydroxyapatite polymer-free sirolimus-eluting stent for the treatment of single de novo coronary lesions: the VESTASYNC I trial. JACC Cardiovasc Interv 2:422–427PubMedCrossRefGoogle Scholar
  54. 54.
    Curcio A, Torella D, Cuda G, Coppola C, Faniello MC, Achille F et al (2004) Effect of stent coating alone on in vitro vascular smooth muscle cell proliferation and apoptosis. Am J Physiol Heart Circ Physiol 286:H902–H908PubMedCrossRefGoogle Scholar
  55. 55.
    Schoenkerman AB, Lundstrom RJ (2009) Coronary stent infections: a case series. Catheter Cardiovasc Interv 73:74–76PubMedCrossRefGoogle Scholar
  56. 56.
    de Belder MA (2008) NICE guidelines for the use of drug-eluting stents: how do we establish worth? Heart 94:1646–1648PubMedCrossRefGoogle Scholar
  57. 57.
    The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS), Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T et al (2010) Guidelines on myocardial revascularization. Eur Heart J 31:2501–2555PubMedCrossRefGoogle Scholar
  58. 58.
    Kereiakes DJ (2010) Safety of drug-eluting stents. Rev Cardiovasc Med 11:187–199, quiz 200PubMedGoogle Scholar
  59. 59.
    Webster MW, Ormiston JA (2007) Drug-eluting stents and late stent thrombosis. Lancet 370:914–915PubMedCrossRefGoogle Scholar
  60. 60.
    Tada N, Virmani R, Grant G, Bartlett L, Black A, Clavijo C et al (2010) Polymer-free biolimus a9-coated stent demonstrates more sustained intimal inhibition, improved healing, and reduced inflammation compared with a polymer-coated sirolimus-eluting cypher stent in a porcine model. Circ Cardiovasc Interv 3:174–183PubMedCrossRefGoogle Scholar
  61. 61.
    Levi Y, Domb AJ, Amir N, Eliyahu N, Cohn U, Tal N. Crystalline drug-containing coatings. WO2010086863 A3, pp 1–55Google Scholar
  62. 62.
    Khan W, Farah S, Domb AJ (2012) Drug eluting stents: developments and current status. J Control Release 161:703–712PubMedCrossRefGoogle Scholar
  63. 63.
    Levy Y, Khan W, Farah S, Domb AJ (2012) Surface crystallization of rapamycin on stents using a temperature induced process. Langmuir 28:6207–6210PubMedCrossRefGoogle Scholar
  64. 64.
    Abizaid A, Costa JR Jr (2010) New drug-eluting stents: an overview on biodegradable and polymer-free next-generation stent systems. Circ Cardiovasc Interv 3:384–393PubMedCrossRefGoogle Scholar
  65. 65.
    Costa JR Jr, Abizaid A, Costa R, Feres F, Tanajura LF, Mattos LA et al (2008) Preliminary results of the hydroxyapatite nonpolymer-based sirolimus-eluting stent for the treatment of single de novo coronary lesions a first-in-human analysis of a third-generation drug-eluting stent system. JACC Cardiovasc Interv 1:545–551PubMedCrossRefGoogle Scholar
  66. 66.
    Mehilli J, Kastrati A, Wessely R, Dibra A, Hausleiter J, Jaschke B et al (2006) Randomized trial of a nonpolymer-based rapamycin-eluting stent versus a polymer-based paclitaxel-eluting stent for the reduction of late lumen loss. Circulation 113:273–279PubMedCrossRefGoogle Scholar
  67. 67.
    Di Mario C, Ferrante G (2008) Biodegradable drug-eluting stents: promises and pitfalls. Lancet 371:873–874PubMedCrossRefGoogle Scholar
  68. 68.
    Ramcharitar S, Serruys PW (2008) Fully biodegradable coronary stents: progress to date. Am J Cardiovasc Drugs 8:305–314PubMedCrossRefGoogle Scholar
  69. 69.
    Erbel R, Di Mario C, Bartunek J, Bonnier J, de Bruyne B, Eberli FR et al (2007) Temporary scaffolding of coronary arteries with bioabsorbable magnesium stents: a prospective, non-randomised multicentre trial. Lancet 369:1869–1875PubMedCrossRefGoogle Scholar
  70. 70.
    Erbel R, Bose D, Haude M, Kordish I, Churzidze S, Malyar N et al (2007) Absorbable coronary stents. New promising technology. Herz 32:308–319PubMedCrossRefGoogle Scholar
  71. 71.
    Tamai H, Igaki K, Kyo E, Kosuga K, Kawashima A, Matsui S et al (2000) Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans. Circulation 102:399–404PubMedCrossRefGoogle Scholar
  72. 72.
    Ormiston JA, Serruys PW (2009) Bioabsorbable coronary stents. Circ Cardiovasc Interv 2:255–260PubMedCrossRefGoogle Scholar
  73. 73.
    Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW et al (2008) A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet 371:899–907PubMedCrossRefGoogle Scholar
  74. 74.
    Garg S, Serruys P (2009) Biodegradable stents and non-biodegradable stents. Minerva Cardioangiol 57:537–565PubMedGoogle Scholar
  75. 75.
    Park K (2012) Dual drug-eluting stent. J Control Release 159:1PubMedCrossRefGoogle Scholar
  76. 76.
    Song SJ, Kim KS, Park YJ, Jeong MH, Ko YM, Cho DL (2009) Preparation of a dual-drug-eluting stent by grafting of ALA with abciximab on a bare metal stent. J Mater Chem 19:8135–8141CrossRefGoogle Scholar
  77. 77.
    Byrne RA, Mehilli J, Iijima R, Schulz S, Pache J, Seyfarth M et al (2009) A polymer-free dual drug-eluting stent in patients with coronary artery disease: a randomized trial vs. polymer-based drug-eluting stents. Eur Heart J 30:923–931PubMedCrossRefGoogle Scholar
  78. 78.
    Ma X, Oyamada S, Gao F, Wu T, Robich MP, Wu H et al (2011) Paclitaxel/sirolimus combination coated drug-eluting stent: in vitro and in vivo drug release studies. J Pharm Biomed Anal 54:807–811PubMedCentralPubMedCrossRefGoogle Scholar
  79. 79.
    Kleinedler JJ, Foley JD, Orchard EA, Dugas TR (2012) Novel nanocomposite stent coating releasing resveratrol and quercetin reduces neointimal hyperplasia and promotes re-endothelialization. J Control Release 159:27–33PubMedCrossRefGoogle Scholar
  80. 80.
    Kukreja N, Onuma Y, Daemen J, Serruys PW (2008) The future of drug-eluting stents. Pharmacol Res 57:171–180PubMedCrossRefGoogle Scholar
  81. 81.
    Variola F, Vetrone F, Richert L, Jedrzejowski P, Yi JH, Zalzal S et al (2009) Improving biocompatibility of implantable metals by nanoscale modification of surfaces: an overview of strategies, fabrication methods, and challenges. Small 5:996–1006PubMedCrossRefGoogle Scholar
  82. 82.
    Youssefian S, Rahbar N (2013) Nano-scale adhesion in multilayered drug eluting stents. J Mech Behav Biomed Mater 18:1–11PubMedCrossRefGoogle Scholar

Copyright information

© Controlled Release Society 2014

Authors and Affiliations

  • Wahid Khan
    • 1
  • Rajesh Thipparaboina
    • 1
  • Shady Farah
    • 2
  • Judah Z. Weinberger
    • 3
  • Abraham J. Domb
    • 2
  1. 1.Department of PharmaceuticsNational Institute of Pharmaceutical Education and Research (NIPER)HyderabadIndia
  2. 2.Faculty of MedicineInstitute of Drug Research, School of Pharmacy, The Hebrew University of JerusalemJerusalemIsrael
  3. 3.Cardiovascular Division, Department of MedicineColumbia UniversityNew YorkUSA

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