Pharmaceutical aspects of drug eluting stents

Journal of Pharmaceutical Sciences

Volumn 97, Issue 12, 2008, Pages 5047-5060

  Deconinck, E ^a,b   Sohier, J ^a   De Scheerder, I ^a   Van Den Mooter, G ^b  

^a Ziscoat NV   (Belgium)

^b DEPARTMENT OF PHARMACEUTICAL AND PHARMACOLOGICAL SCIENCES   (Belgium)

Author keywords

Cardiovascular diseases; Controlled release; Drug eluting stents

Indexed keywords

COPOLYMER; DACTINOMYCIN; DEXAMETHASONE; EVEROLIMUS; PACLITAXEL; POLY(ETHYLENE CO VINYL ACETATE); POLY(N BUTYL METHACRYLATE); POLY(STYRENE B ISOBUTYLENE B STYRENE); POLYGLACTIN; POLYLACTIC ACID; RAPAMYCIN; TACROLIMUS; UNCLASSIFIED DRUG; ZOTAROLIMUS;

ACUTE CORONARY SYNDROME; CONTROLLED RELEASE FORMULATION; DRUG COATING; DRUG ELUTING STENT; DRUG SOLUBILITY; HUMAN; IN-STENT RESTENOSIS; ISCHEMIC HEART DISEASE; NONHUMAN; SHORT SURVEY; SLOW RELEASE FORMULATION;

EID: 57349119942     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21356     Document Type: Article

References (65)

1. Ross R. 1999. Atherosclerosis-an inflammatory disease. N Engl J Med 340:115-126.
2. Faxon D, Fuster V. 2004. Atherosclerotic vascular disease conference: Writing Group III: Pathophysiology. Circulation 109:2617-2625.
3. Orford J, Selwyn A. 2000. The comparative pathobiology of atherosclerosis and restenosis. Am J Cardiol 86:6H-11H.
4. Van der Hoeven BL, Pires NMM, Warda HM, Oemrawsingh PV, van Vlijmen BJM, Quax PHA, Schalij MJ, van der Wall EE, Jukema JW. 2005. Drug-eluting stents: Results, promises and problems. Int J Cardiol 99:9-17.
5. Kivela A, Hartikainen J. 2006. Restenosis related to percutaneous coronary intervention has been solved? Ann Med 38:173-187.
6. Burt HM, Hunter WL. 2006. Drug-eluting stents: An innovative multidisciplinary drug delivery platform. Adv Drug Del Rev 58:345-346.
7. King S, Meier B. 2000. Interventional treatment of coronary heart disease and peripheral vascular disease. Circulation 102:IV81-IV86.
8. Costa MA, Simon DI. 2005. Molecular basis of restenosis and drug-eluting stents. Circulation 111:2257-2273.
9. Scott NA. 2006. Restenosis following implantation of bare metal coronary stents: Pathophysiology and pathways involved in the vascular response to injury. Adv Drug Del Rev 58:358-376.
10. 2™ drug eluting stent. J Biomed Mater Res A 71:625-634.
11. Signore PE, Machan LS, Jackson JK, Burt H, Bromley P, Wilson JE, McManus BM. 2001. Complete inhibition of intimal hyperplasia by perivascular delivery of paclitaxel in balloon-injured rat carotid arteries. J Vasc Interv Radiol 12:79-88.
12. Parry TJ, Brosius R, Thygarajan R, Carter D, Argentieri D, Falotico R, Siekierka J. 2005. Drug-eluting stents: Sirolimus and Paclitaxel differentially affect cultured cells and injured arteries. Eur J Pharm 524:19-29.
13. Kamath KR, Barry JJ, Miller KM. 2006. The Taxus™ drug-eluting stent: A new paradigm in controlled drug delivery. Adv Drug Del Rev 58:412-436.
14. Unverdorben M, Degenhardt R, Wiemer M, Horstkotte D, Schneider H, Nienaber C, Bocksch W, Gross M, Boxberger M, Vallbracht C, for the PECOPS I Investigators. 2007. The Paclitaxel-Eluting Coroflextrade mark Please Stent Pilot Study (PECOPS I): The one-year clinical follow-up. Clin Res Cardiol 96:803-811.
15. Ong AT, Serruys PW. 2005. Technology Insight: An overview of research in drug-eluting stents. Nat Clin Pract Cardiovasc Med 2:647-658.
16. Rahel BM, Laarman GJ, Suttorp MJ. 2005. PRISON II study investigators. Primary stenting of occluded native coronary arteries II-rationale and design of the PRISON II study: A randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of chronic total coronary occlusions. Am Heart J 149:e1-e3.
17. Suttorp MJ, Laarman GJ, Rahel BM, Kelder JC, Bosschaert MA, Kiemeneij F, Ten Berg JM, Bal ET, Rensing BJ, Eefting FD, Mast EG. 2006. Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II): A randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions. Circulation 114:921-928.
18. Ruchin PE, Muller DW, Faddy SC, Baron DW, Roy PR, Wilson SH. 2007. Long-term Clinical follow-up of sirolimus-eluting (CYPHERtrade mark) coronary stents in the treatment of instent restenosis in an unselected population. Heart Lung Circ 16:440-446.
19. Berger A, Stauffer JC, Seydoux C, Siegenthaler M, Benoît A, Goy JJ. 2007. Three-year follow-up of the first prospective randomized comparison between paclitaxel and sirolimus stents: The TAXi-LATE trial. Catheter Cardiovasc Interv 70:163-166.
20. Wessely R, Schomig A, Kastrati A. 2006. Sirolimus and Paclitaxel on polymer-based drug-eluting stents: Similar but different. J Am Coll Cardiol 47:708-714.
21. Kar S, Honda T, Mcclean D, Takizawa K, Fishbein M, Honda H, Shulze J, Eigler N, Litvack F. 2003. Elution of everolimus and sirolimus from a biodegradable polymer coated stent inhibits neointimal hyperplasia without inflammation or toxicity. J Am Coll Cardiol 41:6A.
22. Burke SE, Kuntz RE, Schwartz LB. 2006. Zotarolimus (ABT-578) eluting stents. Adv Drug Del Rev 58:437-446.
23. Kandzari DE, Leon MB. 2006. Overview of pharmacology and Clinical Trials Program with the Zotarolimus-Eluting Endeavor stent. J Int Cardiol 19:405-413.
24. Suttorp MJ, Laarman GJ, PRISON, III, study investigators. 2007. A randomized comparison of sirolimus-eluting stent implantation with zotarolimus-eluting stent implantation for the treatment of total coronary occlusions: Rationale and design of the PRImary Stenting of Occluded Native coronary arteries III (PRISON III) study. Am Heart J 154:432-435.
25. Grube E, Sonoda S, Ikeno F, Honda Y, Kar S, Chan C, Gerckens U, Lansky AJ, Fitzgerals PJ. 2004. Six- and twelve-month results from first human experience using everolimus-eluting stents with bioabsorbable polymer. Circulation 109:2168-2171.
26. Silber S. 2005. Cypher versus taxus: Are there differences? J Interv Cardiol 18:441-446.
27. Liu J, Farmer J, Lane W, Friedman J, Weissman I, Schreiber S. 1991. Calcineurin is a common target of cyclophilin-cyclosporin A and FKBP-FK506 complexes. Cell 66:807-815.
28. Garcia-Tejada J, Gutierrez H, Albarran A, Hernandez F, Velazquez T, Rodriguez S, Gomez I, Tascon J. 2007. Janus tacrolimus-eluting carbostent. Immediate and medium-term clinical results. Rev Esp Cardiol 60:197-200.
29. Serruys PW, Ormiston JA, Sianos G, Sousa JE, Grube E, den Heijer P, de Feyter P, Buszman P, Schomig A, Marco J, Polonski L, Thuesen L, Zeiher AM, Bett JH, Suttorp MJ, Glogar HD, Pitney M, Wilkins GT, Whitbourn R, Veldhof S, Miquel K, Johnson R, Coleman L, Virmani R, ACTION investigators. 2004. Actinomycin-eluting stent for coronary revascularization: A randomized feasibility and safety study: The ACTION trial. J Am Coll Cardiol 44:1363-1367.
30. Zhou Z, Wang K, Lincoff AM. 2005. Chapter 24: The dexamethason eluting stent. In: Camenzind E, De Scheerder IK, editors. Local drug delivery for coronary artery disease, established and emerging application. New York: Taylor and Francis. pp 209-213.
31. Liu X, De Scheerder I, Desmet W. 2004. Dexamethasone-eluting stent: An anti-inflammatory approach to inhibit coronary restenosis. Expert Rev Cardiovasc Ther 2:653-660.
32. Han SH, Ahn TH, Kang WC, Oh KJ, Chung WJ, Shin MS, Koh KK, Choi IS, Shin EK. 2006. The favorable clinical and angiographic outcomes of a high-dose dexamethasone-eluting stent: Randomized controlled prospective study. Am Heart J 152:887e1-887e7.
33. Konig A, Leibig M, Rieber J, Schiele TM, Theisen K, Siebert U, Gothe RM, Klauss V. 2007. Randomized comparison of dexamethasone-eluting stents with bare metal stent implantation in patients with acute coronary syndrome: Serial angiographic and sonographic analysis. Am Heart J 153:979e1-979e8.
34. van der Hoeven BL, Pires NM, Warda HM, Putter H, Quax PH, Schalij MJ, Jukema JW. 2008. Dexamethasone-eluting stents for the prevention of in-stent restenosis: Evidence for a differential effect in insulin-dependent and non-insulin-dependent diabetic patients. Int J Cardiol 124:166-171.
35. Aggarwal RK, Ireland DC, Azrin MA, Ezekowitz MD, de Bono DP, Gershlick AH. 1996. Antithrombotic potential of polymer-coated stents eluting platelet glycoprotein IIb/IIIa receptor antibody. Circulation 94:3311-3317.
36. Acharya G, Park K. 2006. Mechanisms of controlled drug release from drug-eluting stents. Adv Drug Deliv Rev 58:387-401.
37. Keuhler M, Braun Melsungen B. 2005. Chapter 15: Overview of drug delivery coatings. In: Camenzind E, De Scheerder IK, editors. Local drug delivery for coronary artery disease, established and emerging application. New York: Taylor and Francis. pp 127-137.
38. Hwang Chao-Wei AB, Wu D, Edelman ER. 2001. Physiological transport forces govern drug distribution for stent-based delivery. Circulation 104:600-605.
39. Hwang Chao-Wei AB, Wu D, Edelman ER. 2003. Impact of transport and drug properties on the local pharmacology of drug eluting stents. Int J Cardiovasc Interv 5:7-12.
40. Ranade SV, Richard RE, Helmus MN. 2005. Styrenic block copolymers for biomaterial and drug delivery applications. Acta Biomater 1:137-144.
41. Venkatraman S, Boey F. 2007. Release profiles in drug eluting stents: Issues and uncertainties. J Control Release 120:149-160.
42. Sousa JE, Costa MA, Abizaid AC, Rensing BJ, Abizaid AS, Tanajura LF, Kozuma K, Van Langenhove G, Sousa AGMR, Falotico R, Jaeger J, Popma JJ, Serruys PW. 2001. Sustained suppression of neointimal proliferation by sirolimus-eluting stents. Circulation 103:192-195.
43. Serruys PW, Sianos G, Abizaid A, Aoki J, den Heijer P, Bonnier H, Smits P, McClean D, Verheye S, Belardi J, Condado J, Pieper M, Gambone L, Bressers M, Symons J, Sousa E, Litvack F. 2005. The effect of variable dose and release kinetics on neointimal hyperplasia using a novel paclitaxel-eluting stent platform: The Paclitaxel In-Stent Controlled Elution Study (PISCES). J Am Coll Cardiol 46:253-260.
44. Finkelstein A, Mcclean D, Kar S, Takizawa K, Vargeese K, Baek N, Park K, Fishbein MC, Makkar R, Litvack F, Eigler NL. 2003. Local drug delivery via a coronary stent with programmable release pharmacokinetics. Circulation 107:777-784.
45. Bartorelli AL, Trabattoni D, Fabbiocchi F, Montorsi P, De Martini S, Calligaris G, Teruzzi G, Galli S, Ravagnani P. 2003. Synergy of passive coating and targeted drug delivery: The tacrolimus-eluting Janus CarboStent. J Interv Cardiol 16:499-505.
46. Whelan DM, Giessen WJVD, Krabbendam SC, Vliet EAV, Verdouw PD, Serruys PW, Beusekom HMM. 2000. Biocompatibility of phosphorylcholine coated stents in normal porcine coronary arteries. Heart Drug 83:338-345.
47. De Scheerder I, Lewis A, Collias A. 2005. Chapter 16: Phosphorylcholin (PC Technology™) coated stents as a drug delivery platform. In: Camenzind E, De Scheerder IK, editors. Local drug delivery for coronary artery disease, established and emerging application. New York: Taylor and Francis. pp 139-150.
48. Salu KJ, Bosmans JM, Bult H, Vrints CJ. 2005. Chapter 17: Direct stent coating: An alternative for polymers. In: Camenzind E, De Scheerder IK, editors. Local drug delivery for coronary artery disease, established and emerging application. New York: Taylor and Francis. pp 151-161.
49. Heldman AW, Cheng L, Jenkins GM, Heller PF, Kim DW, Ware M, Nater C, Hruban RH, Rezai B, Abella BS, Bunge KE, Kinsella JL, Sollott SJ, Lakatta EG, Brinker JA, Hunter WL, Froehlich JP. 2001. Paclitaxel stent coating inhibits neointimal hyperplasia at 4 weeks in a porcine model of coronary restenosis. Circulation 103:2289-2295.
50. Lansky AJ, Costa RA, Mintz GS, Tsuchiya Y, Midei M, Cox DA, O'shaughnessy C, Applegate RA, Cannon LA, Mooney M, Farah A, Tannenbaum MA, Yakubov S, Kereiakes DJ, Wong SC, Kaplan B, Cristea E, Stone GW, Leon MB, Knopf WD, O'neill WW. 2004. Non-polymer-based paclitaxel-coated coronary stents for the treatment of patients with de novo coronary lesions. Circulation 109:1948-1954.
51. Herdeg C, Oberhoff M, Baumbach A, Blattner A, Axel DI, Schroder S, Heinle H, Karsch KR. 2000. Local paclitaxel delivery for prevention of restenosis: Biological effects and efficacy in vivo. J Am Coll Cardiol 35:1969-1976.
52. Raya SG. 2004. Drug-eluting stents: Is it the beginning of the end for coronary artery bypass surgery? Chin Med J 117:1377-1387.
53. Creel CJ, Lovich MA, Edelman ER. 2000. Arterial paclitaxel distribution and deposition. Circ Res 86:879-884.
54. Wieneke H, Schmermund A, Von Birgelen C, Haude M, Erbel R. 2003. Therapeutic potential of active stent coating. Expert Opin Investig Drugs 12:771-779.
55. 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 3:731-741.
56. Stefanadis C, Toutouzas K, Stefanadi E, Kolodgie F, Virmani R, Kipshidze N. 2006. First experimental application of bevacizumab-eluting PC coated stent for inhibition of vasa vasorum of atherosclerotic plaque: Angiographic results in a rabbit atheromatic model. Hellenic J Cardiol 47:7-10.
57. Chappell LT. 2007. Should EDTA chelation therapy be used instead of long-term clopidogrel plus aspirin to treat patients at risk from drug-eluting stents? Altern Med Rev 12:152-158.
58. Sharkawi T, Cornhill F, Lafont A, Sabaria P, Vert M. 2007. Intravascular bioresorbable polymeric stents: A potential alternative to current drug eluting metal stents. J Pharm Sci 96:2829-2837.
59. Thierry B, Winnik FM, Merhi Y, Silver J, Tabrizian M. 2003. Bioactive coatings of endovascular stents based on polyelectrolyte multilayers. Biomacromolecules 4:1564-1571.
60. Tan Q, Ji J, Barbosa MA, Fonseca C, Shen J. 2003. Constructing thromboresistant surface on biomedical stainless steel via layer-by-layer deposition anticoagulant. Biomaterials 24:4699-4705.
61. Boura C, Menu P, Payan E, Picart C, Voegel JC, Muller S, Stoltz JF. 2003. Endothelial cells grown on thin polyelectrolyte mutlilayered films: An evaluation of a new versatile surface modification. Biomaterials 24:3521-3530.
62. Caves JM, Chaikoff EL. 2006. The evolving impact of microfabrication and nanotechnology on stent design. J Vasc Surg 44:1363-1368.
63. Salu KJ, Huang Y, Bosmans JM, Liu X, Li S, Wang L, Verbeken E, Bult H, Vrints CJ, De Scheerder IK. 2003. Addition of cytochalasin D to a biocompatible oil stent coating inhibits intimal hyperplasia in a porcine coronary model. Coron Artery Dis 14:545-555.
64. International patent application PCT/EP2007/004464
65. Zilberman M, Kraitzer A. 2008. Paclitaxel-eluting composite fibers: Drug release and tensile mechanical properties. J Biomed Mater Res A 84:313-323.