Tzu Chi Medical Journal
Volume 21, Issue 1 , Pages 18-27, March 2009

The Current Status of Coronary Drug-Eluting Stents

  • Chih-Wei Chen

      Affiliations

    • Division of Cardiology, Department of Internal Medicine, Buddhist Dalin Tzu Chi General Hospital, Chiayi, Taiwan
    • Division of Cardiology, Department of Internal Medicine, College of Medicine, Tzu Chi University, Hualien, Taiwan
  • ,
  • Chin-Lon Lin

      Affiliations

    • Division of Cardiology, Department of Internal Medicine, Buddhist Dalin Tzu Chi General Hospital, Chiayi, Taiwan
    • Division of Cardiology, Department of Internal Medicine, College of Medicine, Tzu Chi University, Hualien, Taiwan
    • Corresponding Author InformationCorresponding author. Division of Cardiology, Department of Internal Medicine, Buddhist Dalin Tzu Chi General Hospital, 2, Min-Sheng Road, Dalin, Chiayi, Taiwan

Received 11 August 2008; received in revised form 15 September 2008; accepted 9 October 2008.

Article Outline

Abstract 

Percutaneous coronary intervention is currently the most common revascularization procedure for coronary artery stenosis. Bare metal stents effectively reduce the rates of acute closure and restenosis more successfully than balloon angioplasty. However, the rates of restenosis remain high. Local delivery of drugs using drug-eluting stents to inhibit neointimal pro liferation was proven to be an effective method to reduce in-stent restenosis and hence the rates of target lesions and target vessel revascularization. At present, four drug-eluting stents have been approved by the Food and Drug Administration, including the sirolimus-eluting stent (Cypher), paclitaxel-eluting stent (Taxus), zotarolimus-eluting stent (Endeavor) and everolimus-eluting stent (Xience V). These four drug-eluting stents are effective in reducing in-stent restenosis, and target vessel and lesion revascularization in comparison with bare metal stents. However, the mortality and myocardial infarction rates were similar between bare metal stents and drug-eluting stents. Recently, late and very late stent thrombosis resulting in high rates of mortality and myocardial infarction have become important issues. Discontinuation of dual antiplatelet therapy appeared to be the main etiology of late and very late stent thrombosis. Dual antiplatelet therapy for at least 12 months after deployment of drug-eluting stents is currently recommended by the ACC/AHA guidelines.

Keywords:  Coronary , Drug-eluting , Stent

No full text is available. To read the body of this article, please view the PDF online.

 

Back to Article Outline

References 

  1. Gruentzig AR , King SB , Schlumpf M , Siegenthaler W . Long-term follow-up after percutaneous transluminal coronary angioplasty: the early Zurich experience . N Engl J Med . 1987;316:1127–1132
  2. Gauters C , Isner JM . The biology of restenosis . In:  Topol EJ editors. Textbook of Cardiovascular Medicine . Philadelphia: Lippinocott-Raven; 1998;p. 2465–2490
  3. Holmes DR , Vliestra RE , Smith HC , et al.   Restenosis after percutaneous transluminal coronary angioplasty (PTCA): a report from the PTCA Registry of the National Heart, Lung, and Blood Institute . Am J Cardiol . 1984;53:77–81
  4. Fischman DL , Leon MB , Baim DS , et al.   A randomized comparison of coronary-stent placement and balloon angio-plasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators . N Engl J Med . 1994;331:496–501
  5. Serruys PW , de Jaegere P , Kiemeneij F , et al.   A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group . N Engl J Med . 1994;331:489–495
  6. Bhargava B , Karthikeyan G , Abizaid AS , Mehran R . New approaches to preventing restenosis . BMJ . 2003;327:274–279
  7. Moss JW , Lon MB , Popma JJ , et al.   Sirolimus-elutings versus standard stents in patients with stenosis in a native coronary artery . N Engl J Med . 2003;349:1315–1323
  8. Park SJ , Shim WH , Ho DS , et al.   A paclitaxel-eluting stent for the prevention of coronary restenosis . N Engl J Med . 2003;348:1537–1545
  9. Stone GW , Ellis SG , Cox DA , et al.   One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS-IV trial . Circulation . 2004;109:1942–1947
  10. Nikol S , Huehns TY , Hofling B . Molecular biology and post-angioplasty restenosis . Atherosclerosis . 1996;123:17–31
  11. Rajagopal V , Rockson SG . Coronary restenosis: a review of mechanisms and management . Am J Med . 2003;115:547–553
  12. Casscells W , Engler D , Willerson JT . Mechanisms of reste-nosis . Tex Heart Inst J . 1994;21:68–77
  13. Pakala R , Willerson JT , Benedict CR . Effect of serotonin, thromboxane A2, and specific receptor antagonists on vascular smooth muscle cell proliferation . Circulation . 1997;96:2280–2286
  14. Farb A , Weber DK , Kolodgie FD , Burke AP , Virmani R . Morphological predictors of restenosis after coronary stenting in humans . Circulation . 2002;105:2974–2980
  15. Sollott SJ , Cheng L , Pauly RR , et al.   Taxol inhibits neointi-mal smooth muscle cell accumulation after angioplasty in the rat . J Clin Invest . 1995;95:1869–1876
  16. Meredith IT , Ormiston J , Whitbourn R , et al.   First-in-human study of the Endeavor ABT-578-eluting phosphorylcholine-encapsulated stent system in de novo native coronary artery lesions: Endeavor I Trial . Euro Intervention . 2005;1:157–164
  17. Serruys PW , Ruygrok P , Neuzner J , et al.   A randomised comparison of a durable polymer everolimus-eluting stent with a bare metal coronary stent . Euro Intervention . 2005;1:58–65
  18. Marx SO , Mark AR . Bench to bedside: the development of rapamycin and its application to stent stenosis . Circulation . 2001;104:853–858
  19. Burke SE , Lubbers NL , Chen YW , et al.   Neointimal formation after balloon-induced vascular injury in Yucaran minipigs is reduced by oral rapamycin . J Cardiovasc Pharmacol . 1999;33:829–835
  20. Gallo R , Padurean A , Jayaraman T , et al.   Inhibition of intimal thickening after balloon angioplasty in porcine coronary arteries by targeting regulators of the cell cycle . Circulation . 1999;99:2164–2170
  21. Sousa JE , Costa MA , Abizaid A , et al.   Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angi-ography and three-dimensional intravascular ultrasound study . Circulation . 2001;103:192–195
  22. 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 . 2002;346:1773–1780
  23. Fajadet J , Morice MC , Bode C , et al.   Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents: three-year results of the RAVEL trial . Circulation . 2005;111:1040–1044
  24. 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 . 2003;349:1315–1323
  25. Weisz G , Leon MB , Holmes DR , et al.   Two-year outcomes after sirolimus-eluting stent implantation: results from the sirolimus-Eluting Stent in de Novo Native Coronary Lesions (SIRIUS) trial . J Am Coll Cardiol . 2006;47:1350–1355
  26. Schofer J , Schluter M , Gershlick AH , et al.   Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blinded, randomised controlled trial (E-SIRIUS) . Lancet . 2003;362:1093–1099
  27. Schampaert E , Cohen EA , Schluter M , et al.   The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS) . J Am Coll Cardiol . 2004;43:1110–1115
  28. Schampaert E , Moses JW , Schofer J , et al.   Sirolimus-eluting stents at two years: a pooled analysis of SIRIUS, E-SIRIUS, and C-SIRIUS with emphasis on late revascularization and stent thrombosis . Am J Cardiol . 2006;98:36–41
  29. Kelbaek H , Thuesen L , Helqvist S , et al.   The Stenting Coronary Arteries in Non-stress/benestent Disease (SCANDSTENT) trial . J Am Coll Cardiol . 2006;47:449–455
  30. Kelbaek H , Klovgaard L , Helqvist S , et al.   Long-term outcome in patients treated with sirolimus-eluting stents in complex coronary artery lesions: 3-year results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) trial . J Am Coll Cardiol . 2008;51:2011–2016
  31. Grube E , Silber S , Hauptmann KE , et al.   TAXUS I: six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions . Circulation . 2003;107:38–42
  32. Colombo A , Drzewiecki J , Banning A , et al.   Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions . Circulation . 2003;108:788–794
  33. Stone GW , Ellis SG , Cox DA , et al.   One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS IV trial . Circulation . 2004;109:1942–1947
  34. Stone GW , Ellis SG , Cannon L , et al.   Comparison of a polymer-based paclitaxel-eluting stent with a bare-metal stent in patients with complex coronary artery disease: a randomized control trial . JAMA . 2005;294:1215–1223
  35. Dawkins KD , Grube E , Guagliumi G , et al.   Clinical efficacy of polymer-based paclitaxel-eluting stents in the treatment of complex, long coronary artery lesions from a multicenter, randomized trial: support for the use of drug-eluting stents in contemporary clinical practice . Circulation . 2005;112:3306–3313
  36. Meredith IT , Ormiston J , Whitbourn R , et al.   Four-year clinical follow-up after implantation of the endeavor zotarolimus-eluting stent: ENDEAVOR I, the first-in-human study . Am J Cardiol . 2007;100:56–61
  37. Fajadet J , Wijns W , Laarman GJ , et al.   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 . 2006;114:798–806
  38. Goy JJ , Stauffer JC , Siegenthaler M , Benoit A , Seydoux C . A prospective randomized comparison between paclitaxel and sirolimus stents in the real world of interventional cardiology: the TAXi trial . J Am Coll Cardiol . 2005;45:308–311
  39. Windecker S , Remondino A , Eberli FR , et al.   Sirolimus-eluting and paclitaxel-eluting stents for coronary revascu-larization . N Engl J Med . 2005;353:653–662
  40. Morice MC , Colombo A , Meier B , et al.   Sirolimus-vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial . JAMA . 2006;295:895–904
  41. Galloe AM , Thuesen L , Kelbaek H , et al.   For the SORT OUT II investigators. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SOPT OUT II randomized trial . JAMA . 2008;299:409–416
  42. Kastrati A , Dibra A , Eberle S , et al.   Sirolimus-eluting stents vs paclitaxel-eluting stents in patients with coronary artery disease: meta-analysis of randomized trials . JAMA . 2005;294:819–825
  43. Schomig A , Dibra A , Winkecker S , et al.   A meta-analysis of 16 randomized trials of sirolimus-eluting stents versus paclitaxel-eluting stents in patients with coronary artery disease . J Am Coll Cardiol . 2007;50:1373–1380
  44. Dibra A , Kastrati A , Mehilli J , et al.   Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients . N Engl J Med . 2005;353:663–670
  45. Kim YH , Park SW , Lee SW , et al.   Sirolimus-eluting stent versus paclitaxel-eluting stent for patients with long coronary artery disease . Circulation . 2006;114:2148–2153
  46. Mehilli J , Dibra A , Kastrati A , Pache J , Dirschinger J , Schomig A . Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels . Eur Heart J . 2006;27:260–266
  47. Kandzari DE , Leon MB , Popma JJ , 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 . 2006;48:2440–2447
  48. Kandzari DE , Leon MB . Overview of pharmacology and clinical trials program with the zotarolimus-eluting endeavor stent . J Interv Cardiol . 2006;19:405–413
  49. Serruys PW , Ruygrok P , Neuzner J , et al.   A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent: the SPIRIT II trial . Euro Intervention . 2006;2:286–294
  50. 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 . JAMA . 2008;229:1903–1913
  51. Marzocchi A , Saia F , Piovaccari G , et al.   Long-term safety and efficacy of drug-eluting stents: two-year results of the REAL (REgistro AngiopLastiche dell'Emilia Romagna) mul-ticenter registry . Circulation . 2007;115:3181–3188
  52. Spaulding C , Daemen J , Boersma E , Cutlip DE , Surruys PW . A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents . N Engl J Med . 2007;356:989–997
  53. Cutlip DE , Windecker S , Mehran R , et al.   Clinical end points in coronary stent trials: a case for standardized definitions . Circulation . 2007;115:2344–2351
  54. Lagerqvist B , James SK , Stenestrand U , et al.   Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden . N Engl J Med . 2007;356:1009–1019
  55. Kuchulakanti PK , Chu WW , Torguson R , et al.   Correlates and long-term outcomes of angiographically proven stent thrombosis with sirolimus- and paclitaxel-eluting stents . Circulation . 2006;113:1108–1113
  56. Stone GW , Ellis SG , Colombo A , et al.   Offsetting impact of thrombosis and restenosis on the occurrence of death and myocardial infarction after paclitaxel-eluting and bare metal stent implantation . Circulation . 2007;115:2842–2847
  57. Mauri L , Hsieh WH , Massaro JM , et al.   Stent thrombosis in randomized clinical trials of drug-eluting stents . N Engl J Med . 2007;356:1020–1029
  58. Stone GW , Moses JW , Ellis SG , et al.   Safety and efficacy of sirolimus- and paclitaxel-eluting stents . N Engl J Med . 2007;356:998–1008
  59. Daemen J , Tanimoto S , Garcia-Garcia HM , et al.   Comparison of three-year clinical outcome of sirolimus- and paclitaxel-eluting stents versus bare metal stents in patients with ST-segment elevation myocardial infarction (from the RESEARCH and T-SEARCH Registries) . Am J Cardiol . 2007;99:1027–1032
  60. Daemen J , Wenasester P , Tsuchida K , et al.   Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study . Lancet . 2007;369:667–678
  61. Iakovou I , Schmidt T , Bonizzoni E , et al.   Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents . JAMA . 2005;293:2126–2130
  62. Finn AV , Kolodgie FD , Harnek J , et al.   Differential response of delayed healing and persistent inflammation at sites of overlapping sirolimus- or paclit axel-eluting stents . Circulation . 2005;112:270–278
  63. Hofma SH , van der Giessen WJ , van Dalen BM , et al.   Indication of long-term endothelial dysfunction after sirolimus-eluting stent implantation . Eur Heart J . 2006;27:166–170
  64. Kotani J , Awata M , Nanto S , et al.   Incomplete neointimal coverage of sirolimus-eluting stents: angioscopic findings . J Am Coll Cardiol . 2006;47:2108–2111
  65. Joner M , Finn AV , Farb A , et al.   Pathology of drug-eluting stents in human: delayed healing and late thrombotic risk . J Am Coll Cardiol . 2006;48:193–202
  66. Airoldi F , Colombo A , Morici N , et al.   Incidence and predictors of drug-eluting stent thrombosis during and after discontinuation of thienopyridine treatment . Circulation . 2007;116:745–754
  67. Park DW , Park SW , Park KH , et al.   Frequency of and risk factors for stent thrombosis after drug-eluting stent implantation during long-term follow-up . Am J Cardiol . 2006;98:352–356
  68. Pfisterer M , Brunner-La Rocca HP , Buser PT , et al.   Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observation study of drug-eluting stent versus bare-metal stents . J Am Coll Cardiol . 2006;48:2584–2591
  69. Spertus JA , Kettelkamp R , Vance C , et al.   Prevalence, predictors, and outcomes of premature discontinuation of thienopyridine therapy after drug-eluting stent placement: results from the PREMIER registry . Circulation . 2006;113:2803–2809
  70. King SB , Smith SC , Hirshfeld JW , et al.   2007 Focused Update of the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guideline: 2007 Writing Group to Review New Evidence and Update the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention, Writing on Behalf of the 2005 Writing Committee . Circulation . 2008;117:261–295

PII: S1016-3190(09)60004-5

doi:10.1016/S1016-3190(09)60004-5

Tzu Chi Medical Journal
Volume 21, Issue 1 , Pages 18-27, March 2009