Biocompatibility aspects of new stent technology

Journal of the American College of Cardiology

Volumn 32, Issue 3, 1998, Pages 562-571

  Bertrand, Olivier F ^a   Sipehia, Rajender ^a   Mongrain, Rosaire ^b   Rodés, Josep ^a   Tardif, Jean Claude ^a   Bilodeau, Luc ^a   Côté, Gilles ^a   Bourassa, Martial G ^a  

^a MCGILL UNIVERSITY   (Canada)

^b MONTREAL HEART INSTITUTE   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

HEPARIN; POLYMER;

BIOCOMPATIBILITY; BRACHYTHERAPY; CORONARY ARTERY DILATATION; DRUG COATING; DRUG DELIVERY SYSTEM; HEART CATHETERIZATION; PRIORITY JOURNAL; REVIEW; STENT; THROMBOGENESIS; TREATMENT INDICATION;

EID: 0031692020     PISSN: 07351097     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0735-1097(98)00289-7     Document Type: Article

References (95)

1. Fischman D., Leon M., Baim D., et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. N Engl J Med. 331:1994;496-501.
2. Serruys P., de Jaegere P., Kiemeneij F., et al. A comparison of balloon-expandable stent implantation with balloon angioplasty in patients with coronary disease. N Engl J Med. 331:1994;489-495.
3. Taylor A. Metals. Sigwart U. Endoluminal Stenting. 1996;28-33 WB Saunders, London, Philadelphia, Toronto, Sydney, Tokyo.
4. Dotter C. Transluminally placed coilspring endarterial tube grafts, long term patency in canine popliteal artery. Invest Radiol. 4:1969;329-332.
5. Beyar R., Roguin A. Self expandable nitinol stent for cardiovascular applications canine and human experience . Cathet Cardiovasc Diagn. 32:1994;162-170.
6. Eigler N., Litvak F., Whitlow P. Temporary stents. Topol E. Textbook of Interventional Cardiology. 1994;766-775 WB Saunders, Philadelphia, London, Toronto, Montreal, Sydney, Tokyo.
7. Robinson K., Roubin G., King S. Long-term intracoronary stent placement arteriographic and histologic results after 7 years in a dog model . Cathet Cardiovasc Diagn. 38:1996;32-37.
8. Ratner B., Hoffman A., Schoen F., Lemons J. An introduction to materials in medicine. 1996;Academic Press, San Diego, London, Boston, New York, Sydney, Tokyo, Toronto.
9. Park J.B. Metallic Biomaterials. Branzino J.D. The Biomedical Engineering Handbook. 1995;537-571 CRC Press, Boca Raton.
10. Ryhanen J., Niemi E., Serlo W., Niemela E., Sandvik P., Pernu H., Salo T. Biocompatibility of nickel-titanium shape memory metal and its corrosion behavior in human cell cultures. J Biomed Mater Res. 35:1997;451-457.
11. Castelman L., Motzkin S., Aricandri F., et al. Biocompatibility of nitinol alloy as an implant material. J Biomed Mater Res. 10:1976;695-731.
12. Zitter H., Plenk H. The electromechanical behavior of metallic implant material as an indicator of their biocompatibility. J Biomed Mater Res. 21:1987;881-896.
13. Salzman E.W., Merrill E.W., Kent K.C. Interaction of blood with artificial surfaces. Colman R.W., Hirsh J., Marder V.J., Salzman E.W. Hemostasis and Thrombosis Basic Principles and Clinical Practice . 1994;1469-1485 J.B. Lippincott, Philadelphia.
14. Scott N., Robinson K., Nunes G., et al. Comparison of the thrombogenicity of stainless steel and tantalum coronary stents. Am Heart J. 129:1995;866-872.
15. Rogers C., Edeman E. Endovascular stent design dictates experimental restenosis and thrombosis. Circulation. 91:1995;2995-3001.
16. Barth K., Virmani R., Froelich J., et al. Paired comparison of vascular wall reactions to Palmaz stents, Strecker tantalum stents, and Wallstents in canine iliac and femoral arteries. Circulation. 93:1996;2161-2169.
17. Sheth S., Litvak F., Dev V., Fishbein M., Forrester J., Eigler N. Subacute thrombosis and vascular injury resulting from slotted-tube nitinol and stainless steel stents in a rabbit carotid artery model. Circulation. 94:1996;1733-1740.
18. Fontaine A., Spigos D., Eaton G., et al. Stent-induced intimal hyperplasia are there fundamental differences between flexible and rigid stent designs? J Vasc Interv Radiol. 5:1994;739-744.
19. Buchwald A., Stevens J., Zilz M., et al. Influence of increased wave density of coil stents on the proliferative response in a minipig coronary stent-angioplasty model. [abstract] Eur Heart J. 18:1997;152.
20. Sheth S., Litvak F., Fishbein M., Forrester J., Eigler N. Reduced thrombogenicity of polished and unpolished nitinol vs stainless steel slotted-tube stents in a pig coronary artery model. [abstract] J Am Coll Cardiol. 27:1996;197A.
21. De Scheerder I., Sohier J., Wang K., et al. Metallic surface treatment using electrochemical polishing decreases thrombogenicity and neointimal hyperplasia after coronary stent implantation in a porcine model. [abstract] Eur Heart J. 18:1997;153.
22. Hermann R., Schmidmaier G., Alt E., et al. Comparison of the thrombogenicity of steel and gold-surface coronary stents with a biodegradable drug releasing coating in a human stasis model. [abstract] Eur Heart J. 18:1997;152.
23. Hehrlein C., Zimmerman M., Metz J., Ensinger W., Kubler W. Influence of surface texture and charge on the biocompatibility of endovascular stents. Coronary Artery Dis. 6:1995;581-586.
24. van der Giessen W., van Beusekom H., van Houten C., van Woerkens L., Verdouw P., Serruys P. Coronary stenting with polymer-coated and uncoated self-expanding endoprostheses in pigs. Coronary Artery Dis. 3:1992;631-640.
25. van der Giessen W., Lincoff A., Schwartz R., et al. Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation. 94:1996;1690-1697.
26. De Scheerder I., Wilczek K., Verbeken E., et al. Biocompatibility of polymer-coated oversized metallic stents implanted in normal porcine coronary arteries. Atherosclerosis. 114:1995;105-114.
27. Fontaine A., Koelling K., Clay J. Decreased platelet adherence of polymer-coated tantalum stents. J Vasc Interv Radiol. 5:1994;567-572.
28. Rechavia E., Fishbien M., DeFrance T., Nakamura M., Litvak F., Eigler N. Vascular injury triggered by temporary and permanently implanted polyurethane coated and uncoated stents in rabbit carotid arteries. [abstract] Circulation. 94:1996;I-88.
29. Chronos N., Robinson K., Kelly A., et al. Thromboresistant phosphorylcholine coating for coronary stents. [abstract] Circulation. 92:1995;I-685.
30. Malik N., Gunn J., Sheperd L., Newman C., Crossman D., Cumberland D. Phosphorylcholine-coated stents in porcine coronary arteries angiographic and morphometric assessment . [abstract] Eur Heart J. 18:1997;152.
31. Nordrehaug J., Chronos N., Sigwart U. A biocompatible phosphotidylcholine coating applied to metallic stents. [abstract] J Am Coll Cardiol. 23:1994;5A.
32. Amon M., Winkler S., Dekker A., Bolz A., Mittermayer C., Schaldach M. Introduction of a new coronary stent with enhanced radioopacity and hemocompatibility. IEEE Engin Med Biol Soc. 7:1995;120-121.
33. Özbek C., Heisel A., Grob B., Bay W., Schieffer H. Coronary implantation of silicone-carbide-coated Palmaz-Schatz stents in patients with high risk of stent thrombosis without oral anticoagulation. Cathet Cardiovasc Diagn. 41:1997;71-78.
34. Lincoff A., Furst J., Ellis S., Tuch R., Topol E. Sustained local delivery of dexamethasone by a novel intravascular eluting stent to prevent restenosis in the porcine coronary injury model. J Am Coll Cardiol. 29:1997;808-816.
35. Staab M.E., Holmes D.R., Schwartz R.S. Polymers. Sigwart U. Endoluminal Stenting. 1996;34-44 WB Saunders, London.
36. Holmes D., Camrud A., Jorgenson M., Edwards W., Schwartz R. Polymeric stenting in the porcine coronary artery model differential outcome of exogenous fibrin sleeves versus polyurethane-coated stents . J Am Coll Cardiol. 24:1994;525-531.
37. Baker J., Horn J., Nikolaychik V., Kipshidze N. Fibrin stent coatings. Sigwart U. Endoluminal Stenting. 1996;84-89 WB Saunders, London, Philadelphia, Toronto, Sydney, Tokyo.
38. Kipshidze N., Baker J., Nikolaychik N. Fibrin coated stents as an improved vehicle for endothelial cell seeding. [abstract] Circulation. 90:1994;I-597.
39. Stefanidis C., Toutouzas K., Vlachopoulos C., et al. Stents wrapped in autologous vein an experimental study . Circulation. 28:1996;1039-1046.
40. Stefanidis C., Toutouzas K., Tsiamis E., et al. Preliminary results by using the autologous arterial graft-coated stent for the treatment of coronary artery disease. [abstract] Eur Heart J. 18:1997;154.
41. Bonan R., Bhat K., Lefèvre T., et al. Coronary artery stenting after angioplasty with self-expanding parallel wire metallic stents. Am Heart J. 121:1991;1522-1530.
42. Stratienko A., Zhu D., Lambert C., Palmaz J., Schatz R. Improved thromboresistance of heparin coated Palmaz-Schatz coronary stents in an animal model. [abstract] Circulation. 88:1993;I-596.
43. Bailey S. Coating of endovascular stents. In: Topol E, ed. Textbook of Interventional Cardiology. 1994:754-765.
44. Sheth S., Dev V., Jacobs H., Forrester J., Litvak F., Eigler N. Prevention of subacute stent thrombosis by polymer-polyethylene oxide-heparin coating in the rabbit carotid artery. [abstract] J Am Coll Cardiol. 25:1995;348A.
45. Hardhammar P., Van Beusekom H., Emanuelsson H., et al. Reduction in thrombotic events with heparin-coated Palmaz-Schatz stents in normal coronary arteries. Circulation. 93:1996;423-430.
46. Serruys P., Emanuelsson H., Van der Giessen W., et al. Heparin-coated Palmaz-Schatz stents in human coronary arteries early outcome of the Benestent-II pilot study . Circulation. 93:1996;412-422.
47. Chronos N., Robinson K., White D., et al. Heparin coating dramatically reduces platelet deposition on incompletely deployed Palmaz-Schatz in the baboon A-V shunt. [abstract] J Am Coll Cardiol. 27:1996;84A.
48. 111In-platelet deposition in baboon carotid arteries . [abstract] Circulation. 92:1995;I-490.
49. Chronos N., Robinson K., Kelly A., et al. Neointima formation in stented baboon carotid arteries is reduced by bonded heparin correlation with decreased thrombogenicity . [abstract] J Am Coll Cardiol. 27:1996;85A.
50. Zidar J., Virmani R., Culp S., et al. Quantitative histopathologic analysis of the vascular response to heparin coating of the Cordis stent. [abstract] J Am Coll Cardiol. 21:1993;336A.
51. Zidar J., Jackman J., Gammon R., et al. Serial assessment of heparin coating on vascular responses to a new tantalum stent. [abstract] Circulation. 89:1992;I-185.
52. de Scheerder I., Wang K., Wilczek K., et al. Experimental study of thrombogenicity and foreign body reaction induced by heparin-coated coronary stents. Circulation. 95:1997;1549-1553.
53. Cox D., Anderson P., Roubin G., Chou C., Agrawal S., Cavender J. Effects of local delivery of heparin and methotrexate on neointimal proliferation in stented porcine coronary arteries. Coron Artery Dis. 3:1992;237-248.
54. Jeong M., Owen W., Staab M., et al. Does heparin release coating of the Wallstent limit thrombosis and platelet deposition? Results in a porcine carotid injury model . [abstract] Circulation. 92:1995;I-37.
55. Legrand V., Serruys P.W., Emanuelsson H., et al. Benestent II trial - final results of visit 1:a 15-day follow-up. [abstract] J Am Coll Cardiol. 29:1997;170A.
56. Vrolix M., Grollier G., Legrand V., et al. Heparin-coated wire coil (Wiktor) for elective stent placement-The MENTOR trial. [abstract] Eur Heart J. 18:1997;155.
57. Lambert T., Dev V., Rechavia E., Forrester J., Litvak F., Eigler N. Localized arterial wall drug delivery from a polymer-coated removable metallic stent kinetics, distribution, and bioactivity of forskolin . Circulation. 90:1994;1003-1011.
58. Dev V., Eigler N., Sheth S., Lambert T., Forrester J., Litvak F. Kinetics of drug delivery to the arterial wall via polyurethane-coated removable nitinol stent Comparative study of two drugs . Cathet Cardiovasc Diagn. 34:1995;272-278.
59. de Scheerder I., Wang K., Wilczek K., et al. Local methylprednisolone inhibition of foreign body response to coated intracoronary stents. Coronary Artery Dis. 7:1996;161-166.
60. de Scheerder I., Wilczek K., Van Dorpe J. Angiopeptin loaded stents inhibit the neointimal reaction induced by polymer coated stents implanted in porcine coronary arteries. [abstract] Circulation. 90:1994;I-597.
61. Eccleston D., Lincoff A., Furst J. Administration of colchicine using a novel prolonged delivery stent produces a marked local biological effect within the porcine coronary artery. [abstract] Circulation. 92:1995;I-67.
62. Alt E., Beilharz C., Preter G., et al. Biodegradable stent coating with polylactic acid, hirudin and prostacyclin reduces restenosis. [abstract] J Am Coll Cardiol. 29:1997;238A.
63. Prietzel K., Pasquantonio J., Fliedner T., Stemberger A., Janczewski M. Inhibition of neointimal proliferation with a novel hirudin/prostacyclin analog eluting stent coating in an animal overstretch model. [abstract] Circulation. 94:1996;I-260.
64. Schmidmaier G., Stemberger A., Alt E., Gawaz M., Neumann F., Schömig A. A new biodegradable polylactic acid coronary stent-coating, releasing PEG-Hirudin and a prostacycline analog, reduces both platelet activation and plasmatic coagulation. [abstract] J Am Coll Cardiol. 29:1997;354A.
65. Schmidmaier G., Stemberger A., Alt E., Gawaz M., Schömig A. Time release characteristics of a biodegradable stent coating with polylactic acid releasing PEG-hirudin and PGI2-analog. [abstract] J Am Coll Cardiol. 29:1997;94A.
66. Aggarwal R., Ireland D., Azrin M., Ezekowitz M., De Bono D., Gershlick A. Antithrombotic potential of polymer-coated stents eluting platelet glycoprotein IIb/IIIa receptor antibody. Circulation. 94:1996;3311-3317.
67. Aggarwal R., Ireland D., Azrin M., de Bono D., Gershlik A. Reduction in thrombogenicity of cellulose polymer-coated stents by immobilisation of platelet-targeted urokinase. [abstract] J Am Coll Cardiol. 29:1997;353A.
68. Baron J., Aggrawal R., de Bono D., Gershlick A. Adsorption and elution of c7E3 Fab from polymer-coated stents in-vitro. [abstract] Eur Heart J. 18:1997;503.
69. Folts J., Maalej N., Keaney J., Loscalzo J. Coating Palmaz-Schatz stents with a unique NO donor renders them much less thrombogenic when placed in pig carotid arteries. [abstract] Circulation. 92:1995;I-670.
70. Folts J., Maalej N., Keaney J., Loscalzo J. Palmaz-Schatz stents coated with a NO donor reduces reocclusion when placed in pig carotid arteries for 28 days. [abstract] J Am Coll Cardiol. 27:1996;86A.
71. Baker J., Nikolaychik V., Zulich A., Komorowski R., Kipshidze N. Fibrin coated stents as depot to deliver RGD peptide inhibit vascular reaction in atherosclerotic rabbit model. [abstract] J Am Coll Cardiol. 27:1996;197A.
72. Santos R., Tanguay J., Kruse K., et al. Local administration of L-703,801 with a composite polymer stent reduces platelet deposition in canine coronary arteries. [abstract] J Am Coll Cardiol. 29:1997;418A.
73. Murphy J., Schwartz R., Edwards W., Camrud A., Vliestra R., Holmes D. Percutaneous polymeric stents in porcine coronary arteries. Circulation. 86:1992;1596-1604.
74. Van der Giessen W., Slager C., Gussenhoven E., et al. Mechanical features and in vivo imaging of a polymer stent. Int J Card Imag. 9:1993;219-226.
75. Susawa T., Shiraki K., Shimizu Y. Biodegradable intracoronary stents in adult dogs. [abstract] J Am Coll Cardiol. 21:1993;483A.
76. Zidar J., Lincoff A., Stack R. Biodegradable stents. Topol E. Textbook of Interventional Cardiology. 1994;787-802 WB Saunders, Philadelphia, London, Toronto, Montreal, Sydney, Tokyo.
77. Bier J., Zalesky P., Sasken H., Williams D. A new bioabsorbable intravascular stent in vitro assessment of hemodynamic and morphometric characteristics . [abstract] Circulation. 84:1991;II-197.
78. Gregory K., Grunkemeier J. Internal elastic lamina replacement with a new elastin stent biomaterial. [abstract] Circulation. 90:1994;I-596.
79. Gao R., Shi R., Qiao S., Song L., Li Y. A novel polymeric local heparin delivery stent initial experimental study . [abstract] J Am Coll Cardiol. 27:1996;85A.
80. Ye Y., Landau C., Meidell R.S., et al. Improved bioresorbable microporous intravascular stents for gene therapy. ASAIOJ. 42:1996;M823-M827.
81. Dichek D., Neville R., Zwiebel J., Freeman S., Leon M., Anderson W. Seeding of intravascular stents with genetically engineered endothelial cells. Circulation. 80:1989;1347-1353.
82. Flugelman M., Virmani R., Leon M., Bowman R., Dichek D. Genetically engineered endothelial cells remain adherent and viable after stent deployment and exposure to flow in vitro. Circulation. 70:1992;348-354.
83. Scott N., Candal F., Robinson K., Ades E. Seeding of intracoronary stents with immortalized human microvascular endothelial cells. Am Heart J. 129:1995;860-866.
84. Bailey S.R., Decento Y.J., Sprague E. Endothelial sodding intraprocedural replacement of endothelial cells on endovascular stents . [abstract] Circulation. 94:1997;I-261.
85. Van Belle E., Tio F., Couffinhal T., Maillard L., Passeri J., Isner J. Stent endothelialization Time course, impact of local catheter delivery, feasibility of recombinant protein administration and response to cytokine expedition . Circulation. 95:1997;438-448.
86. 165 inhibits thrombus formation and intimal thickening. J Am Coll Cardiol. 29:1997;1371-1379.
87. Bertrand O.F., Mongrain R., Lehnert S., et al. Intravascular radiation therapy in atherosclerotic disease promises and premises . Eur Heart J. 18:1997;1385-1395.
88. Hehrlein C., Gollan C., Dönges K., et al. Low-dose radioactive endovascular stents prevent smooth muscle cell proliferation and neointimal hyperplasia in rabbits. Circulation. 92:1995;1570-1575.
89. Hehrlein C., Stintz M., Kinscherf R., et al. Pure β-particle emitting stents inhibits neointima formation in rabbits. Circulation. 93:1996;641-645.
90. Carter A., Laird J., Bailey L., et al. Effects of endovascular radiation from a β-particle-emitting stent in a porcine coronary restenosis model A dose-response study . Circulation. 94:1996;2364-2368.
91. American Society for Testing and Materials, eds. Annual Book of ASTM Standards, 1992;13:F139-F86.
92. Bertrand OF, Mongrain R, Bilodeau L, Tanguay JF. Radioactivity local delivery system. In: PCT patent application (W097/38730).
93. Williams D. Definitions in Biomaterials Consensus Conference of the European Society for Biomaterials . 1987;Elsevier, Chester.
94. Stokes K. Biodegradation. Cardiovasc Pathol. 2:1993;111S-119S.
95. Horbett T. Principles underlying the role of adsorbed plasma proteins in blood interactions with foreign materials. Cardiovasc Pathol. 2:1993;137S-148S.