Benchside testing of drug-eluting stent surface and geometry

Interventional Cardiology

Volumn 2, Issue 2, 2010, Pages 159-175

  Von Birgelen, Clemens ^a   Basalus, Mounir W Z ^a  

^a Department of Cardiology ^*

Author keywords

benchside testing; biodegradable polymer; coating irregularity; drug eluting stent; durable polymer; kissing balloon; micro computed tomography; postdilatation; postdilation; scanning electron microscopy; stent geometry; stent surface; stent thrombosis; vessel phantoms

Indexed keywords

ETHYLENE VINYL ACETATE COPOLYMER; METHACRYLIC ACID DERIVATIVE; POLYETHYLENE DERIVATIVE; POLYMER; RAPAMYCIN;

BIODEGRADABLE IMPLANT; CLASSIFICATION; DRUG ELUTING STENT; GEOMETRY; IMAGE ANALYSIS; MATERIAL COATING; MICRO-COMPUTED TOMOGRAPHY; PERFORMANCE; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; SAFETY; SCANNING ELECTRON MICROSCOPY; STENT THROMBOSIS; SURFACE PROPERTY; THICKNESS;

EID: 77954100840     PISSN: 17555302     EISSN: 17555310     Source Type: Journal    
DOI: 10.2217/ica.10.11     Document Type: Review

References (82)

1. Grube E, Silber S, Hauptmann KE et al.: TAXUS I: six-and twelve-month results from a randomized, double-blind trial on randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation 107, 38-42 (2003).
2. Morice MC, Serruys PW, Sousa JE et al.: A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N. Engl. J. Med. 346, 1773-1780 (2002).
3. Moses JW, Leon MB, Popma JJ et al.: Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N. Engl. J. Med. 349, 1315-1323 (2003).
4. Stone GW, Midei M, Newman W et al.: Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA 299, 1903-1913 (2008).
5. Kastrati A, Mehilli J, Pache J et al.: Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N. Engl. J. Med. 356, 1030-1039 (2007).
6. Stettler C, Wandel S, Allemann S et al.: Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet 370, 937-948 (2007).
7. Finn AV, Nakazawa G, Kolodgie FD, Virmani R: Temporal course of neointimal formation after drug-eluting stent placement: is our understanding of restenosis changing? JACC. Cardiovasc. Interv. 2, 300-302 (2009).
8. Schulz S, Schuster T, Mehilli J et al.: Stent thrombosis after drug-eluting stent implantation: incidence, timing, and relation to discontinuation of clopidogrel therapy over a 4-year period. Eur. Heart J. 30, 2714-2721 (2009).
9. Finn AV, Nakazawa G, Joner M et al.: Vascular responses to drug eluting stents: importance of delayed healing. Arterioscler. Thromb. Vasc. Biol. 27, 1500-1510 (2007).
10. Jimenez-Valero S, Moreno R, Sanchez-Recalde A: Very late drug-eluting stent thrombosis related to incomplete stent endothelialization: in vivo demonstration by optical coherence tomography. J. Invasive. Cardiol. 21, 488-490 (2009).
11. Joner M, Finn AV, Farb A et al.: Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J. Am. Coll. Cardiol. 48, 193-202 (2006).
12. Ellis SG: A generation 2.5 drug-eluting stent? JACC. Cardiovasc. Interv. 2, 986-988 (2009).
13. Brodie BR, Stuckey T, Downey W et al.: Outcomes and complications with off-label use of drug-eluting stents: results from the STENT (Strategic Transcatheter Evaluation of New Therapies) group. JACC. Cardiovasc. Interv. 1, 405-414 (2008).
14. Byrne RA, Joner M, Kastrati A: Polymer coatings and delayed arterial healing following drug-eluting stent implantation. Minerva Cardioangiol. 57, 567-584 (2009).
15. Vroman L: The life of an artifcial device in contact with blood: initial events and their effect on its fnal state. Bull. NY Acad. Med. 64, 352-357 (1988).
16. van der Giessen WJ, Lincoff AM, Schwartz RS et al.: Marked infammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation 94, 1690-1697 (1996).
17. How TV: Mechanical properties of arteries and arterial grafts. In: Cardiovascular Biomaterials. Springer-Verlag Ltd, London, UK 1-36 (1992).
18. Hunter WL: Drug-eluting stents: beyond the hyperbole. Adv. Drug Deliv. Rev. 58, 347-349 (2006).
19. Schwartz RS: Pathophysiology of restenosis: interaction of thrombosis, hyperplasia, and/or remodeling. Am. J. Cardiol. 81, E14-E17 (1998).
20. Nebeker JR, Virmani R, Bennett CL et al.: Hypersensitivity cases associated with drug-eluting coronary stents: a review of available cases from the Research on Adverse Drug Events and Reports (RADAR) project. J. Am. Coll. Cardiol. 47, 175-181 (2006).
21. Kounis NG, Kounis GN, Kouni SN et al.: Allergic reactions following implantation of drug-eluting stents: a manifestation of Kounis syndrome? J. Am. Coll. Cardiol. 48, 592-593 (2006).
22. Cook S, Ladich E, Nakazawa G et al.: Correlation of intravascular ultrasound fndings with histopathological analysis of thrombus aspirates in patients with very late drug-eluting stent thrombosis. Circulation 120, 391-399 (2009).
23. Hecker JF: Roughness and thrombogenicity of the outer surfaces of intravascular catheters. J. Biomed. Mater Res. 19, 381-395 (1985).
24. Palmaz JC: Infuence of surface topography on endothelialization of intravascular metallic material. J. Vasc. Interv. Radiol. 10, 448-460 (1999).
25. Pinchuk L, Wilson GJ, Barry JJ et al.: Medical applications of poly(styrene-block-isobutylene-block-styrene) ('SIBS'). Biomaterials 29, 448-460 (2008).
26. Biela SA, Su Y, Spatz JP, Kemkemer R: Different sensitivity of human endothelial cells, smooth muscle cells and fbroblasts to topography in the nano-micro range. Acta Biomater. 5, 2460-2466 (2009).
27. Introduction to Biomedical Engineering. Enderle JD, Brozino JD, Blanchard SM (Eds). Academic Press, Elsevier (2005).
28. Basalus MW, Ankone MJ, van Houwelingen GK, de Man FH, von Birgelen C: Coating irregularities of durable polymer-based drug-eluting stents as assessed by scanning electron microscopy. EuroIntervention 5, 157-165 (2009).
29. Ormiston JA, Panther M, Pornratanarangsi S: The 'pitiful' polymer, scanning electron microscope observations. Presented at: Transcatheter Cardiovascular Therapeutics Symposium. Washington DC, USA, 17 October, 2005.
30. Otsuka Y, Chronos NA, Apkarian RP, Robinson KA: Scanning electron microscopic analysis of defects in polymer coatings of three commercially available stents: comparison of BiodivYsio®, Taxus® and Cypher® stents. J. Invasive. Cardiol. 19, 71-76 (2007).
31. Basalus MW, van Houwelingen KG, Ankone M, de Man FH, von Birgelen C: Scanning electron microscopic assessment of the biodegradable coating on expanded biolimus-eluting stents. EuroIntervention. 5, 505-510 (2009).
32. Ormiston JA, Webster M, Ruygrok P: Polymer integrity after Cypher® and Taxus® stent implantation: scanning electron microscope study. Presented at: DES symposium at Transcatheter Cardiovascular Therapeutics. Washington DC, USA, 1 October, 2004.
33. Wilson GJ, Nakazawa G, Schwartz RS et al.: Comparison of infammatory response after implantation of sirolimus-and paclitaxel-eluting stents in porcine coronary arteries. Circulation 120, 141-142 (2009).
34. Joner M, Nakazawa G, Finn AV et al.: Endothelial cell recovery between comparator polymer-based drug-eluting stents. J. Am. Coll. Cardiol. 52, 333-342 (2008).
35. Guerin P, Pilet P, Finet G: Drug-eluting stents in bifurcations: bench study of strut deformation and bench study of strut deformation and coating coating lesions. Presented at: EuroPCR. Barcelona, Spain, 21 May (2009).
36. Garg S: Does stent design impact the outcome in bifurcation treatment? Presented at: EuroPCR. Barcelona, Spain, 20 May (2009).
37. Rittersma SZ, de Winter RJ, Koch KT et al.: Impact of strut thickness on late luminal loss after coronary artery stent placement. Am. J. Cardiol. 93, 477-480 (2004).
38. Pache J, Kastrati A, Mehilli J et al.: Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO-2) trial. J. Am. Coll. Cardiol. 41, 1283-1288 (2003).
39. Schulz C, Herrmann RA, Beilharz C, Pasquantonio J, Alt E: Coronary stent symmetry and vascular injury determine experimental restenosis. Heart 83, 462-467 (2000).
40. Mani G, Feldman MD, Patel D, Agrawal CM: Coronary stents: a materials perspective. Biomaterials 28, 1689-1710 (2007).
41. Parsonage E, Girton T, Knapp D: Biomaterial considerations for drug-eluting stents. Conf. Proc. IEEE Eng Med. Biol. Soc. 1, 2416-2417 (2009).
42. Okabe T, Asakura Y, Ishikawa S et al.: Evaluation of scaffolding effects of fve different types of stents by intravascular ultrasound analysis. Am. J. Cardiol. 84, 981-986 (1999).
43. Tanigawa J, Barlis P, Dimopoulos K et al.: The infuence of strut thickness and cell design on immediate apposition of drug-eluting stents assessed by optical coherence tomography. Int. J. Cardiol. 134, 180-188 (2009).
44. von Birgelen C, Kutryk MJ, Serruys PW: Three-dimensional intravascular ultrasound analysis of coronary stent deployment and in-stent neointimal volume: current clinical practice and the concepts of TRAPIST, ERASER, and ITALICS. J. Invasive. Cardiol. 10, 17-26 (1998).
45. Ako J, Bonneau HN, Honda Y, Fitzgerald PJ: Design criteria for the ideal drug-eluting stent. Am. J. Cardiol. 100, 3M-9M (2007).
46. Barlis P: Use of optical coherence tomography in interventional cardiology. Interv. Cardiol. 1, 63-71 (2009).
47. Sano K, Mintz GS, Carlier SG et al.: Volumetric intravascular ultrasound assessment of neointimal hyperplasia and nonuniform stent strut distribution in sirolimus-eluting stent restenosis. Am. J. Cardiol. 98, 1559-1562 (2006).
48. von Birgelen C, Erbel R: The stent is here to stay: a note on stenting, ultrasound imaging, and the prevention of restenosis. Eur. Heart J. 23, 595-597 (2002).
49. von Birgelen C, Mintz GS, Bose D et al.: Impact of moderate lesion calcium on mechanisms of coronary stenting as assessed with three-dimensional intravascular ultrasound in vivo. Am. J. Cardiol. 92, 5-10 (2003).
50. Hara H, Nakamura M, Palmaz JC, Schwartz RS: Role of stent design and coatings on restenosis and thrombosis. Adv. Drug Deliv. Rev. 58, 377-386 (2006).
51. Hwang CW, Wu D, Edelman ER: Physiological transport forces govern drug distribution for stent-based delivery Circulation 104, 600-605 (2001).
52. Takebayashi H, Mintz GS, Carlier SG et al.: Nonuniform strut distribution correlates with more neointimal hyperplasia after sirolimus-eluting stent implantation. Circulation 110, 3430-3434 (2004).
53. Mosseri M, Satler LF, Pichard AD, Waksman R: Impact of vessel calcifcation on outcomes after coronary stenting. Cardiovasc. Revasc. Med. 6, 147-153 (2005).
54. Tanigawa J, Barlis P, Di MC: Heavily calcifed coronary lesions preclude strut apposition despite high pressure balloon dilatation and rotational atherectomy: in-vivo demonstration with optical coherence tomography. Circ. J. 72, 157-160 (2008).
55. 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).
56. Migliavacca F, Petrini L, Colombo M, Auricchio F, Pietrabissa R: Mechanical behavior of coronary stents investigated through the fnite element method. J. Biomech. 35, 803-811 (2002).
57. Ormiston JA, Webster MW, Ruygrok PN et al.: Stent deformation following simulated side-branch dilatation: a comparison of fve stent designs. Catheter. Cardiovasc. Interv. 47, 258-264 (1999).
58. Ormiston JA, Currie E, Webster MW et al.: Drug-eluting stents for coronary bifurcations: insights into the crush technique. Catheter. Cardiovasc. Interv. 63, 332-336 (2004).
59. Ormiston JA, Webster MW, El JS et al.: Drug-eluting stents for coronary bifurcations: bench testing of provisional side-branch strategies. Catheter. Cardiovasc. Interv. 67, 49-55 (2006).
60. Ritman EL: Micro-computed tomography-current status and developments. Annu. Rev. Biomed. Eng 6, 185-208 (2004).
61. Ormiston JA, Webster MW, Webber B et al.: The 'crush' technique for coronary artery bifurcation stenting: insights from micro-computed tomographic imaging of bench deployments. JACC Cardiovasc. Interv. 1, 351-357 (2008).
62. Hikichi Y, Inoue T, Node K: Benefts and limitations of cypher stent-based bifurcation approaches: in vitro evaluation using micro-focus CT scan. J. Interv. Cardiol. 22, 128-134 (2009).
63. Mortier P, Van LD, De BM et al.: Comparison of drug-eluting stent cell size using micro-CT: important data for bifurcation stent selection. EuroIntervention. 4, 391-396 (2008).
64. Sketch MH Jr, Ball M, Rutherford B et al.: Evaluation of the Medtronic (Driver) cobalt-chromium alloy coronary stent system. Am. J. Cardiol. 95, 8-12 (2005).
65. Hezi-Yamit A, Sullivan C, Wong J et al.: Novel high-throughput polymer biocompatibility screening designed for SAR (structure-activity relationship): application for evaluating polymer coatings for cardiovascular drug-eluting stents. Comb. Chem. High Throughput. Screen. 12, 664-676 (2009).
66. Wiemer M, Butz T, Schmidt W et al.: Scanning electron microscopic analysis of different drug eluting stents after failed implantation: from nearly undamaged to major damaged polymers. Catheter Cardiovasc. Interv. DOI: 10.1002/ccd.22347 (2010) (Epub ahead of print).
67. von Birgelen C, Basalus MW: On the loss of the phosphorylcholine-based DES coating on the abluminal surface of Endeavor® stents. Catheter Cardiovasc Interv. DOI: 10.1002/ccd.22497 (2010) (Epub ahead of print).
68. Canan T, Lee MS: Drug-eluting stent fracture: incidence, contributing factors, and clinical implications. Catheter Cardiovasc. Interv. 75, 237-245 (2010).
69. Shaikh F, Maddikunta R, Djelmami-Hani M et al.: Stent fracture, an incidental fnding or a signifcant marker of clinical in-stent restenosis? Catheter Cardiovasc. Interv. 71, 614-618 (2008).
70. Doi H, Maehara A, Mintz GS et al.: Classifcation and potential mechanisms of intravascular ultrasound patterns of stent fracture. Am. J. Cardiol. 103, 818-823 (2009).
71. Nukala RK, Boyapally H, Slipper IJ, Mendham AP, Douroumis D: The application of electrostatic dry powder deposition technology to coat drug-eluting stents. Pharm. Res. 27, 72-81 (2009).
72. Coradin T, Boissiere M, Livage J: Sol-gel chemistry in medicinal science. Curr. Med. Chem. 13, 99-108 (2006).
73. Silber S: Non-US physician-scientist perspectives: device regulation and approvals. FDA town hall meeting. Presented at: Transcatheter Cardiovascular Therapeutics. Barcelona, Spain, 23 September, 2009.
74. Center for Devices and Radiological Health: Non-clinical tests and recommended labeling for intravascular stents and associated delivery systems. Guidance for Industry and FDA Staff (2005).
75. Jabara R, Chronos N, Robinson K: Novel bioabsorbable salicylate-based polymer as a drug-eluting stent coating. Catheter. Cardiovasc. Interv. 72, 186-194 (2008).
76. Krucoff M W, Kereiakes DJ, Petersen JL et al.: A novel bioresorbable polymer paclitaxel-eluting stent for the treatment of single and multivessel coronary disease: primary results of the COSTAR (Cobalt Chromium Stent With Antiproliferative for Restenosis) II study. J. Am. Coll. Cardiol. 51, 1543-1552 (2008).
77. Byrne RA, Mehilli J, Iijima R et al.: 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, 923-931 (2009).
78. Costa JR, Jr., Abizaid A, Costa R et al.: 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, 422-427 (2009).
79. Virmani R: Non-polymeric drug-eluting stents-BIOFREEDOM. EuroPCR (2009).
80. Leon MB: The endeavor and endeavor resolute zotarolimus-eluting stent: comprehensive update of the clinical trial program (featuring the frst presentation of the endeavor iv 3-year results). Presented at: Transcatheter Cardiovascular Therapeutics. San Francisco, CA, USA, 21 September, 2009.
81. Erbel R, Di MC, Bartunek J et al.: Temporary scaffolding of coronary arteries with bioabsorbable magnesium stents: a prospective, non-randomised multicentre trial. Lancet 369, 1869-1875 (2007).
82. Serruys PW, Ormiston JA, Onuma Y et al.: A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet 373, 897-910 (2009).