Design Criteria for the Ideal Drug-Eluting Stent

American Journal of Cardiology

Volumn 100, Issue 8 SUPPL. 2, 2007, Pages

  Ako, Junya ^a   Bonneau, Heidi N ^b   Honda, Yasuhiro ^a   Fitzgerald, Peter J ^a  

^a STANFORD UNIVERSITY MEDICAL CENTER   (United States)

^b Highlands Consulting Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALLOY; CHROMIUM; COBALT; HEPARIN; NITINOL;

ARTICLE; BIODEGRADABILITY; CELL PROLIFERATION; CORONARY ARTERY DISEASE; DRUG DELIVERY SYSTEM; DRUG ELUTING STENT; HUMAN; INTIMA; MATERIALS MANAGEMENT; PRIORITY JOURNAL; RESTENOSIS; SAFETY; SURGICAL TECHNIQUE; THROMBOSIS; VASCULAR SMOOTH MUSCLE;

CORONARY DISEASE; CORONARY RESTENOSIS; DRUG-ELUTING STENTS; EQUIPMENT DESIGN; HUMANS; SAFETY;

EID: 35348879238     PISSN: 00029149     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.amjcard.2007.08.016     Document Type: Article

References (52)

1. Kastrati A., Mehilli J., Pache J., Kaiser C., Valgimigli M., Kelbaek H., Menichelli M., Sabate M., Suttorp M.J., Baumgart D., et al. Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 356 (2007) 1030-1039
2. Lagerqvist B., James S.K., Stenestrand U., Lindback J., Nilsson T., and Wallentin L. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med 356 (2007) 1009-1019
3. Maisel W.H. Unanswered questions-drug-eluting stents and the risk of late thrombosis. N Engl J Med 356 (2007) 981-984
4. Schmidt W., Grabow N., Behrens P., and Schmitz K.P. Trackability, crossability, and pushability of coronary stent systems-an experimental approach. Biomed Tech (Berl) 47 suppl (2002) 124-126
5. Urban P., Gershlick A.H., Guagliumi G., Guyon P., Lotan C., Schofer J., Seth A., Sousa J.E., Wijns W., Berge C., Deme M., and Stoll H.P. Safety of coronary sirolimus-eluting stents in daily clinical practice: one-year follow-up of the e-Cypher registry. Circulation 113 (2006) 1434-1441
6. Hoye A., Iakovou I., Ge L., van Mieghem C.A., Ong A.T., Cosgrave J., Sangiorgi G.M., Airoldi F., Montorfano M., Michev I., et al. Long-term outcomes after stenting of bifurcation lesions with the "crush" technique: predictors of an adverse outcome. J Am Coll Cardiol 47 (2006) 1949-1958
7. Yamasaki M., Honda Y., Hongo Y., George B., Nikolchev J., Yock P., Fitzgerald P., and Gradman M. Safety and feasibility of novel guidewire-based self-expanding stent delivery system. [abstract]. Am J Cardiol 96 suppl (2005) 33H
8. Abizaid A., Costa J.J., Whitbourn R., and Chang J. The CardioMind coronary stent delivery system: stent delivery on a .014" guidewire platform. EuroIntervention 3 (2007) 154-157
9. Ormiston J.A., Webster M.W., and Armstrong G. First-in-human implantation of a fully bioabsorbable drug-eluting stent: the BVS poly-L-lactic acid everolimus-eluting coronary stent. Catheter Cardiovasc Interv 69 (2007) 128-131
10. Erbel R., Di Mario C., Bartunek J., Bonnier J., de Bruyne B., Eberli F.R., Erne P., Haude M., Heublein B., Horrigan M., et al. Temporary scaffolding of coronary arteries with bioabsorbable magnesium stents: a prospective, non-randomised multicentre trial. Lancet 369 (2007) 1869-1875
11. Commandeur S., van Beusekom H.M., and van der Giessen W.J. Polymers, drug release, and drug-eluting stents. J Interv Cardiol 19 (2006) 500-506
12. Kastrati A., Mehilli J., Dirschinger J., Dotzer F., Schuhlen H., Neumann F.J., Fleckenstein M., Pfafferott C., Seyfarth M., and Schomig A. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO) trial. Circulation 103 (2001) 2816-2821
13. Pache J., Kastrati A., Mehilli J., Schuhlen H., Dotzer F., Hausleiter J., Fleckenstein M., Neumann F.J., Sattelberger U., Schmitt C., et al. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO-2) trial. J Am Coll Cardiol 41 (2003) 1283-1288
14. Cilingiroglu M., Elliott J., Patel D., Tio F., Matthews H., McCasland M., Trauthen B., Elicker J., and Bailey S.R. Long-term effects of novel biolimus eluting DEVAX AXXESS plus nitinol self-expanding stent in a porcine coronary model. Catheter Cardiovasc Interv 68 (2006) 271-279
15. Hwang C.W., Wu D., and Edelman E.R. Physiological transport forces govern drug distribution for stent-based delivery. Circulation 104 (2001) 600-605
16. Sano K., Mintz G.S., Carlier S.G., Fujii K., Takebayashi H., Kimura M., Costa Jr. J.R., Tanaka K., Costa R.A., Lui J., et al. Volumetric intravascular ultrasound assessment of neointimal hyperplasia and nonuniform stent strut distribution in sirolimus-eluting stent restenosis. Am J Cardiol 98 (2006) 1559-1562
17. Takebayashi H., Mintz G.S., Carlier S.G., Kobayashi Y., Fujii K., Yasuda T., Costa R.A., Moussa I., Dangas G.D., Mehran R., et al. Nonuniform strut distribution correlates with more neointimal hyperplasia after sirolimus-eluting stent implantation. Circulation 110 (2004) 3430-3434
18. © Custom NX drug eluting stent systems. EuroIntervention 3 (2007) 158-161
19. Kotani J., Awata M., Nanto S., Uematsu M., Oshima F., Minamiguchi H., Mintz G.S., and Nagata S. Incomplete neointimal coverage of sirolimus-eluting stents: angioscopic findings. J Am Coll Cardiol 47 (2006) 2108-2111
20. Hofma S.H., van der Giessen W.J., van Dalen B.M., Lemos P.A., McFadden E.P., Sianos G., Ligthart J.M., van Essen D., de Feyter P.J., and Serruys P.W. Indication of long-term endothelial dysfunction after sirolimus-eluting stent implantation. Eur Heart J 27 (2006) 166-170
21. Ako J., Morino Y., Honda Y., Hassan A., Sonoda S., Yock P.G., Leon M.B., Moses J.W., Bonneau H.N., and Fitzgerald P.J. Late incomplete stent apposition after sirolimus-eluting stent implantation: a serial intravascular ultrasound analysis. J Am Coll Cardiol 46 (2005) 1002-1005
22. Kandzari D.E., Leon M.B., Popma J.J., Fitzgerald P.J., O'Shaughnessy C., Ball M.W., Turco M., Applegate R.J., Gurbel P.A., Midei M.G., et al. Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: a randomized controlled trial. J Am Coll Cardiol 48 (2006) 2440-2447
23. Camenzind E. Treatment of in-stent restenosis-back to the future?. N Engl J Med 355 (2006) 2149-2151
24. Suzuki T., Kopia G., Hayashi S., Bailey L.R., Llanos G., Wilensky R., Klugherz B.D., Papandreou G., Narayan P., Leon M.B., et al. Stent-based delivery of sirolimus reduces neointimal formation in a porcine coronary model. Circulation 104 (2001) 1188-1193
25. Hongo Y., Ako J., Sakurai R., Miyazawa A., Sousa E., Hayashi E., Chan C., Verheye S., Neumann F., Horstkotte D., et al. Intravascular ultrasound assessment of the safety and efficacy of heparin-coated sirolimus-eluting stent in small vessel stenting. [abstract]. J Am Coll Cardiol 45 (2005) 72A
26. de Jaegere P., Serruys P.W., van Es G.A., Bertrand M., Wiegand V., Marquis J.F., Vrolicx M., Piessens J., Valeix B., Kober G., et al. Recoil following Wiktor stent implantation for restenotic lesions of coronary arteries. Cathet Cardiovasc Diagn 32 (1994) 147-156
27. Haude M., Erbel R., Issa H., and Meyer J. Quantitative analysis of elastic recoil after balloon angioplasty and after intracoronary implantation of balloon-expandable Palmaz-Schatz stents. J Am Coll Cardiol 21 (1993) 26-34
28. Rechavia E., Litvack F., Macko G., and Eigler N.L. Influence of expanded balloon diameter on Palmaz-Schatz stent recoil. Cathet Cardiovasc Diagn 36 (1995) 11-16
29. Serruys P., De Jaegere P., Bertrand M., Kober G., Marquis J.F., Piessens J., Uebis R., Valeix B., and Wiegand V. Morphologic change in coronary artery stenosis with the Medtronic Wiktor stent: initial results from the core laboratory for quantitative angiography. Cathet Cardiovasc Diagn 24 (1991) 237-245
30. Tanimoto S, Serruys PW, Thuesen L, Dudek D, de Bruyne B, Chevalier B, Ormiston JA. Comparison of in vivo acute stent recoil between the bioabsorbable everolimus-eluting coronary stent and the everolimus-eluting cobalt chromium coronary stent: insights from the ABSORB and SPIRIT trials. Catheter Cardiovasc Interv. Published online 14 May 2007 at http://www3.interscience.wiley.com/cgi-bin/abstract/114263199/ABSTRACT?CRETRY=1&SRETRY=O.
31. Kobayashi Y., Honda Y., Christie G.L., Teirstein P.S., Bailey S.R., Brown III C.L., Matthews R.V., De Franco A.C., Schwartz R.S., Goldberg S., et al. Long-term vessel response to a self-expanding coronary stent: a serial volumetric intravascular ultrasound analysis from the ASSURE [A Stent vs. Stent Ultrasound Remodeling Evaluation] trial. J Am Coll Cardiol 37 (2001) 1329-1334
32. Grube E., Buellesfeld L., Neumann F.J., Verheye S., Abizaid A., McClean D., Mueller R., Lansky A., Mehran R., Costa R., et al. Six-month clinical and angiographic results of a dedicated drug-eluting stent for the treatment of coronary bifurcation narrowings. Am J Cardiol 99 (2007) 1691-1697
33. Tamai H., Igaki K., Kyo E., Kosuga K., Kawashima A., Matsui S., Komori H., Tsuji T., Motohara S., and Uehata H. Initial and 6-month results of biodegradable poly-l-lactic acid coronary stents in humans. Circulation 102 (2000) 399-404
34. Waksman R., Pakala R., Kuchulakanti P.K., Baffour R., Hellinga D., Seabron R., Tio F.O., Wittchow E., Hartwig S., Harder C., et al. Safety and efficacy of bioabsorbable magnesium alloy stents in porcine coronary arteries. Catheter Cardiovasc Interv 68 (2006) 607-617
35. Park D.W., Hong M.K., Suh I.W., Hwang E.S., Lee S.W., Jeong Y.H., Kim Y.H., Lee C.W., Kim J.J., Park S.W., and Park S.J. Results and predictors of angiographic restenosis and long-term adverse cardiac events after drug-eluting stent implantation for aorto-ostial coronary artery disease. Am J Cardiol 99 (2007) 760-765
36. Costa R.A., Mintz G.S., Carlier S.G., Lansky A.J., Moussa I., Fujii K., Takebayashi H., Yasuda T., Costa Jr. J.R., Tsuchiya Y., et al. Bifurcation coronary lesions treated with the "crush" technique: an intravascular ultrasound analysis. J Am Coll Cardiol 46 (2005) 599-605
37. Koster R., Vieluf D., Kiehn M., Sommerauer M., Kahler J., Baldus S., Meinertz T., and Hamm C.W. Nickel and molybdenum contact allergies in patients with coronary in-stent restenosis. Lancet 356 (2000) 1895-1897
38. Palmaz J.C., Bailey S., Marton D., and Sprague E. Influence of stent design and material composition on procedure outcome. J Vasc Surg 36 (2002) 1031-1039
39. Sheth S., Litvack F., Dev V., Fishbein M.C., Forrester J.S., and 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
40. Sketch Jr. M.H., Ball M., Rutherford B., Popma J.J., Russell C., and Kereiakes D.J. Evaluation of the Medtronic (Driver) cobalt-chromium alloy coronary stent system. Am J Cardiol 95 (2005) 8-12
41. Lau K.W., Mak K.H., Hung J.S., and Sigwart U. Clinical impact of stent construction and design in percutaneous coronary intervention. Am Heart J 147 (2004) 764-773
42. Eggebrecht H., Rodermann J., Hunold P., Schmermund A., Bose D., Haude M., and Erbel R. Images in cardiovascular medicine. Novel magnetic resonance-compatible coronary stent: the absorbable magnesium-alloy stent. Circulation 112 (2005) e303-e304
43. Abbott announces positive nine-month results from the world's first clinical trial of a fully bioabsorbable drug eluting coronary stent. Life Sci News (2007). http://news.biocompare.com/newsstory.asp?id=183860 May 22. Available at: http://news.biocompare.com/newsstory.asp?id=183860. Accessed June 28, 2007.
44. Joner M., Finn A.V., Farb A., Mont E.K., Kolodgie F.D., Ladich E., Kutys R., Skorija K., Gold H.K., and Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol 48 (2006) 193-202
45. Luscher T.F., Steffel J., Eberli F.R., Joner M., Nakazawa G., Tanner F.C., and Virmani R. Drug-eluting stent and coronary thrombosis: biological mechanisms and clinical implications. Circulation 115 (2007) 1051-1058
46. Grube E., Sonoda S., Ikeno F., Honda Y., Kar S., Chan C., Gerckens U., Lansky A.J., and Fitzgerald P.J. Six- and twelve-month results from first human experience using everolimus-eluting stents with bioabsorbable polymer. Circulation 109 (2004) 2168-2171
47. Serruys P.W., Sianos G., Abizaid A., Aoki J., den Heijer P., Bonnier H., Smits P., McClean D., Verheye S., Belardi J., et al. 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 (2005) 253-260
48. van der Giessen W.J., Lincoff A.M., Schwartz R.S., van Beusekom H.M., Serruys P.W., Holmes Jr. D.R., Ellis S.G., and Topol E.J. Marked inflammatory sequelae to implantation of biodegradable and nonbiodegradable polymers in porcine coronary arteries. Circulation 94 (1996) 1690-1697
49. Fajadet J., Wijns W., Laarman G.J., Kuck K.H., Ormiston J., Munzel T., Popma J.J., Fitzgerald P.J., Bonan R., and Kuntz R.E. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation 114 (2006) 798-806
50. Tsujino I., Ako J., Honda Y., and Fitzgerald P.J. Drug delivery via nano-, micro and macroporous coronary stent surfaces. Expert Opin Drug Deliv 4 (2007) 287-295
51. Mehilli J., Kastrati A., Wessely R., Dibra A., Hausleiter J., Jaschke B., Dirschinger J., and Schomig A. 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 (2006) 273-279
52. Aoki J., Serruys P.W., van Beusekom H., Ong A.T., McFadden E.P., Sianos G., van der Giessen W.J., Regar E., de Feyter P.J., Davis H.R., et al. Endothelial progenitor cell capture by stents coated with antibody against CD34: the HEALING-FIM (Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth-First in Man) Registry. J Am Coll Cardiol 45 (2005) 1574-1579