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Drug-Eluting Stents in Percutaneous Coronary Intervention

A Benefit-Risk Assessment

  • Review Article
  • Published:
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Abstract

Drug-eluting stent (DES) therapy has represented a very significant milestone in the evolution of percutaneous coronary intervention (PCI) therapy. This review attempts to provide a balanced overview of the unprecedented wealth of data generated on this new technology, by examining the evidence bases for anti-restenotic efficacy, safety and cost effectiveness. The performance of a DES may be related to each of its three components: stent backbone; carrier polymer (to control drug-release kinetics); and active drug. In terms of anti-restenotic efficacy, the most appropriate parameters to examine are target lesion revascularization, angiographic restenosis and late luminal loss. The principal safety parameters are overall mortality, myocardial infarction (MI) and stent thrombosis. Anti-restenotic superiority of DES over bare metal stents (BMS) has been demonstrated across a spectrum of disease from straightforward ‘vanilla lesions’ through higher disease complexity in pivotal clinical trials to phase IV studies of efficacy in ‘off-label’ populations. The treatment effect of DES versus BMS is consistent in terms of a reduction in the need for repeat intervention of the order of 35–70%. Regarding differential efficacy of first-generation DES, a benefit may exist in favour of the Cypher® (sirolimus-eluting) stent over Taxus® (paclitaxel-eluting), particularly in high-risk lesion subsets. The second-generation approved devices are the Endeavor® (zotarolimus-eluting) and Xience™ (everolimus-eluting) DES. While all four of these stents are permanent polymer-based, the current focus of development is towards DES platforms that are devoid of durable polymer, the presence of which has been implicated in late adverse events. In terms of safety concerns raised in relation to DES therapy, it is reasonable to conclude the following at 4- to 5-year post-stent implantation: (i) that there is no increased risk of death or MI with DES (neither is there a general signal of mortality reduction with DES) compared with BMS; and (ii) there is very little, if any, overall increased risk of stent thrombosis with DES compared with BMS, although a difference in the time distribution of thrombotic events after PCI may exist, i.e. a slight excess of events with BMS in the first 6 months and with DES beyond 12 months. Duration of dual anti-platelet therapy after stenting is a central issue and is also, at present, a matter of clinical equipoise. A threshold for cost effectiveness likely exists where the price premium associated with DES is approximately h450. On the balance of benefit and risk data available, DES implantation should be the preferred approach across the spectrum of patients with obstructive coronary disease who require PCI therapy.

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Notes

  1. 1Proprietary stent types combine these components in a specific manner, which effects drug-elution kinetics and performance. As such, proprietary stent names are preferred over generic names in this review.

References

  1. Grüntzig AR. Transluminal dilatation of coronary-artery stenosis [letter]}. Lancet 1978 Feb 4; 311(8058): 263

    Article  Google Scholar 

  2. Palmaz JC, Sibbitt RR, Reuter SR, et al. Expandable intraluminal graft: a preliminary study. Work in progress. Radiology 1985 Jul; 156(1): 73–7766

    PubMed  CAS  Google Scholar 

  3. Schatz RA, Palmaz JC, Tio FO, et al. Balloon-expandable intracoronary stents in the adult dog. Circulation 1987 Aug; 76(2): 450–7

    Article  PubMed  CAS  Google Scholar 

  4. Puel J, Joffre F, Rousseau H, et al. Self-expanding coronary endoprosthesis in the prevention of restenosis following transluminal angioplasty: preliminary clinical study. Arch Mal Coeur Vaiss 1987 Jul; 80(8): 1311–2

    PubMed  CAS  Google Scholar 

  5. Sigwart U, Puel J, Mirkovitch V, et al. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med 1987 Mar 19; 316(12): 701–6

    Article  PubMed  CAS  Google Scholar 

  6. Serruys PW, de Jaegere P, Kiemeneij F, et al., on behalf of the Benestent Study Group. A comparison of balloonexpandable-stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med 1994 Aug 25; 331(8): 489–95

    Article  PubMed  CAS  Google Scholar 

  7. Fischman DL, Leon MB, Baim DS, et al., on behalf of the Stent Restenosis Study Investigators. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. N Engl J Med 1994 Aug 25; 331(8): 496–501

    Article  PubMed  CAS  Google Scholar 

  8. Bertrand ME, Rupprecht HJ, Urban P, et al. Double-blind study of the safety of clopidogrel with and without a loading dose in combination with aspirin compared with ticlopidine in combination with aspirin after coronary stenting: the clopidogrel aspirin stent international cooperative study (CLASSICS). Circulation 2000 Aug 8; 102(6): 624–9

    Article  PubMed  CAS  Google Scholar 

  9. Leon MB, Baim DS, Popma JJ, et al., on behalf of the Stent Anticoagulation Restenosis Study Investigators. A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. N Engl J Med 1998 Dec 3; 339(23): 1665–71

    Article  PubMed  CAS  Google Scholar 

  10. Schomig A, Neumann FJ, Kastrati A, et al. A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents. N Engl J Med 1996 Apr 25; 334(17): 1084–9

    Article  PubMed  CAS  Google Scholar 

  11. 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 Jun 6; 346(23): 1773–80

    Article  PubMed  CAS  Google Scholar 

  12. Camenzind E, Steg PG, Wijns W. Stent thrombosis late after implantation of first-generation drug-eluting stents: a cause for concern. Circulation 2007 Mar 20; 115(11): 1440–55

    Article  PubMed  Google Scholar 

  13. Nordmann AJ, Briel M, Bucher HC. Mortality in randomized controlled trials comparing drug-eluting vs bare metal stents in coronary artery disease: a meta-analysis. Eur Heart J 2006 Dec; 27(23): 2784–814

    Article  PubMed  CAS  Google Scholar 

  14. Kip KE, Hollabaugh K, Marroquin OC, et al. The problem with composite end points in cardiovascular studies: the story of major adverse cardiac events and percutaneous coronary intervention. J Am Coll Cardiol 2008 Feb 19; 51(7): 701–7

    Article  PubMed  Google Scholar 

  15. Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007 May 1; 115(17): 2344–51

    Article  PubMed  Google Scholar 

  16. Mukherjee D, Moliterno DJ. Effectiveness of drug-eluting stents in real-world patients. JAMA 2008 Jan 30; 299(4): 454–5

    Article  PubMed  CAS  Google Scholar 

  17. Grube E, Silber S, Hauptmann KE, et al. TAXUS I: sixand twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation 2003 Jan 7; 107(1): 38–42

    Article  PubMed  CAS  Google Scholar 

  18. Serruys PW. ARTS I: the rapamycin eluting stent; ARTS II: the rosy prophecy. Eur Heart J 2002 May; 23(10): 757–9

    Article  PubMed  CAS  Google Scholar 

  19. 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 Oct 2; 349(14): 1315–23

    Article  PubMed  CAS  Google Scholar 

  20. Stone GW, Ellis SG, Cox DA, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004 Jan 15; 350(3): 221–31

    Article  PubMed  CAS  Google Scholar 

  21. 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 Aug 22; 114(8): 798–806

    Article  PubMed  CAS  Google Scholar 

  22. 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 2008 Apr 23; 299(16): 1903–13

    Article  PubMed  CAS  Google Scholar 

  23. 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 controlled trial. JAMA 2005 Sep 14; 294(10): 1215–23

    Article  PubMed  CAS  Google Scholar 

  24. Beohar N, Davidson CJ, Kip KE, et al. Outcomes and complications associated with off-label and untested use of drug-eluting stents. JAMA 2007 May 9; 297(18): 1992–2000

    Article  PubMed  CAS  Google Scholar 

  25. Win HK, Caldera AE, Maresh K, et al. Clinical outcomes and stent thrombosis following off-label use of drugeluting stents. JAMA 2007 May 9; 297(18): 2001–9

    Article  PubMed  CAS  Google Scholar 

  26. Marroquin OC, Selzer F, Mulukutla SR, et al. A comparison of bare-metal and drug-eluting stents for off-label indications. N Engl J Med 2008 Jan 24; 358(4): 342–52

    Article  PubMed  CAS  Google Scholar 

  27. 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 Dec 19; 48(12): 2440–7

    Article  PubMed  CAS  Google Scholar 

  28. Leon MB. Endeavor IV: a randomized comparison of a zotarolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease. Washington, DC: Transcatheter Cardiovascular Therapeutics, 2007

    Google Scholar 

  29. Lassen JF. SORT-OUT III: a prospective, randomized comparison of zotarolimus-eluting stents and sirolimuseluting stents in patients with coronary artery disease. Washington, DC: Transcatheter Therapeutics, 2008

    Google Scholar 

  30. Virmani R, Guagliumi G, Farb A, et al. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation 2004 Feb 17; 109(6): 701–5

    Article  PubMed  Google Scholar 

  31. 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 2006 Jul 4; 48(1): 193–202

    Article  PubMed  Google Scholar 

  32. Luscher TF, Steffel J, Eberli FR, et al. Drug-eluting stent and coronary thrombosis: biological mechanisms and 767 clinical implications. Circulation 2007 Feb 27; 115(8): 1051–8

    Article  PubMed  Google Scholar 

  33. Windecker S, Serruys PW, Wandel S, et al. Biolimuseluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised noninferiority trial. Lancet 2008 Sep 27; 372(9644): 1163–73

    Article  PubMed  CAS  Google Scholar 

  34. Mehilli J, Byrne RA, Wieczorek A, et al. Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis. Eur Heart J 2008 Aug; 29(16): 1975–82

    Article  PubMed  CAS  Google Scholar 

  35. Han Y, Jing Q, Xu B, et al. Safety and efficacy of biodegradable polymer-coated sirolimus-eluting stents in “real-world” practice: 18-month clinical and 9-month angiographic outcomes. JACC Cardiovasc Interv 2009 Apr; 2(4): 303–9

    Article  PubMed  Google Scholar 

  36. CostaJrJR, 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 2009 May; 2(5): 422–7

    Article  Google Scholar 

  37. 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 2009 Mar 14; 373(9667): 897–910

    Article  PubMed  CAS  Google Scholar 

  38. Adriaenssens T, Mehilli J, Wessely R, et al. Does addition of estradiol improve the efficacy of a rapamycin-eluting stent? Results of the ISAR-PEACE randomized trial. J Am Coll Cardiol 2007 Mar 27; 49(12): 1265–71

    Article  PubMed  CAS  Google Scholar 

  39. Verheye S, Agostoni P, Dawkins KD, et al. The GENESIS (Randomized, Multicenter Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System in Patients with De Novo Lesions of the Native Coronary Arteries) trial. JACC Cardiovasc Interv 2009 Mar; 2(3): 205–14

    Article  PubMed  Google Scholar 

  40. 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 (ISAR-TEST-2). Eur Heart J 2009 Apr; 30(8): 923–31

    Article  PubMed  CAS  Google Scholar 

  41. Stettler C, Allemann S, Wandel S, et al. Drug eluting and bare metal stents in people with and without diabetes: collaborative network meta-analysis. BMJ 2008; 337: a1331

    Article  PubMed  Google Scholar 

  42. Kumbhani DJ, Bavry AA, Kamdar AR, et al. The effect of drug-eluting stents on intermediate angiographic and clinical outcomes in diabetic patients: insights from randomized clinical trials. Am Heart J 2008 Apr; 155(4): 640–7

    Article  PubMed  CAS  Google Scholar 

  43. Gurm HS, Boyden T, Welch KB. Comparative safety and efficacy of a sirolimus-eluting versus paclitaxel-eluting stent: a meta-analysis. Am Heart J 2008 Apr; 155(4): 630–9

    Article  PubMed  CAS  Google Scholar 

  44. Schömig A, Dibra A, Windecker 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 Oct 2; 50(14): 1373–80

    Article  PubMed  CAS  Google Scholar 

  45. Kastrati A, Dibra A, Spaulding C, et al. Meta-analysis of randomized trials on drug-eluting stents vs bare-metal stents in patients with acute myocardial infarction. Eur Heart J 2007 Nov; 28(22): 2706–13

    Article  PubMed  Google Scholar 

  46. Boyden TF, Nallamothu BK, Moscucci M, et al. Metaanalysis of randomized trials of drug-eluting stents versus bare metal stents in patients with diabetes mellitus. Am J Cardiol 2007 May 15; 99(10): 1399–402

    Article  PubMed  CAS  Google Scholar 

  47. Pasceri V, Patti G, Speciale G, et al. Meta-analysis of clinical trials on use of drug-eluting stents for treatment of acute myocardial infarction. Am Heart J 2007 May; 153(5): 749–54

    Article  PubMed  CAS  Google Scholar 

  48. Stone GW, Moses JW, Ellis SG, et al. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med 2007 Mar 8; 356(10): 998–1008

    Article  PubMed  CAS  Google Scholar 

  49. Kastrati A, Mehilli J, Pache J, et al. Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 2007 Mar 8; 356(10): 1030–9

    Article  PubMed  CAS  Google Scholar 

  50. Stettler C, Wandel S, Allemann S, et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet 2007 Sep 15; 370(9591): 937–48

    Article  PubMed  CAS  Google Scholar 

  51. Schampaert E, Moses JW, Schofer J, et al. Sirolimuseluting stents at two years: a pooled analysis of SIRIUS, E-SIRIUS, and C-SIRIUS with emphasis on late revascularizations and stent thromboses. Am J Cardiol 2006 Jul 1; 98(1): 36–41

    Article  PubMed  CAS  Google Scholar 

  52. Stettler C, Allemann S, Egger M, et al. Efficacy of drug eluting stents in patients with and without diabetes mellitus: indirect comparison of controlled trials. Heart 2006 May; 92(5): 650–7

    Article  PubMed  CAS  Google Scholar 

  53. Roiron C, Sanchez P, Bouzamondo A, et al. Drug eluting stents: an updated meta-analysis of randomised controlled trials. Heart 2006 May; 92(5): 641–9

    Article  PubMed  CAS  Google Scholar 

  54. 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 Aug 17; 294(7): 819–25

    Article  PubMed  CAS  Google Scholar 

  55. Brar SS, Leon MB, Stone GW, et al. Use of drug-eluting stents in acute myocardial infarction: a systematic review and meta-analysis. J Am Coll Cardiol 2009 May 5; 53(18): 1677–89

    Article  PubMed  Google Scholar 

  56. Kirtane AJ, Gupta A, Iyengar S, et al. Safety and efficacy of drug-eluting and bare metal stents: comprehensive meta-analysis of randomized trials and observational studies. Circulation 2009 Jun 30; 119(25): 3198–206

    Article  PubMed  CAS  Google Scholar 

  57. 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 2003 Apr 16; 41(8): 1283–8

    Article  PubMed  Google Scholar 

  58. Kastrati A, Mehilli J, Dirschinger J, et al. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO) trial. Circulation 2001 Jun 12; 103(23): 2816–21

    Article  PubMed  CAS  Google Scholar 

  59. Pache J, Dibra A, Mehilli J, et al. Drug-eluting stents compared with thin-strut bare stents for the reduction of restenosis: a prospective, randomized trial. Eur Heart J 2005 Jul; 26(13): 1262–8

    Article  PubMed  Google Scholar 

  60. Costa MA, Simon DI. Molecular basis of restenosis and drug-eluting stents. Circulation 2005 May 3; 111(17): 2257–73

    Article  PubMed  Google Scholar 

  61. Byrne RA, Iijima R, Mehilli J, et al. Durability of antirestenotic efficacy in drug-eluting stents with and without 768 permanent polymer. J Am Coll Cardiol Interv 2009 Apr; 2(4): 291–9

    Google Scholar 

  62. Tung R, Kaul S, Diamond GA, et al. Narrative review: drug-eluting stents for the management of restenosis: a critical appraisal of the evidence. Ann Intern Med 2006 Jun 20; 144(12): 913–9

    PubMed  Google Scholar 

  63. Wessely R, Schömig A, Kastrati A. Sirolimus and paclitaxel on polymer-based drug-eluting stents: similar but different. J Am Coll Cardiol 2006 Feb 21; 47(4): 708–14

    Article  PubMed  CAS  Google Scholar 

  64. Moliterno DJ. Healing Achilles: sirolimus versus paclitaxel. N Engl J Med 2005 Aug 18; 353(7): 724–7

    Article  PubMed  CAS  Google Scholar 

  65. Windecker S, Remondino A, Eberli FR, et al. Sirolimuseluting and paclitaxel-eluting stents for coronary revascularization. N Engl J Med 2005 Aug 18; 353(7): 653–62

    Article  PubMed  CAS  Google Scholar 

  66. Galløe AM, Thuesen L, Kelbaek H, et al. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA 2008 Jan 30; 299(4): 409–16

    Article  PubMed  Google Scholar 

  67. Pocock SJ, Lansky AJ, Mehran R, et al. Angiographic surrogate end points in drug-eluting stent trials: a systematic evaluation based on individual patient data from 11 randomized, controlled trials. J Am Coll Cardiol 2008 Jan 1; 51(1): 23–32

    Article  PubMed  Google Scholar 

  68. 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 Feb 22; 295(8): 895–904

    Article  PubMed  CAS  Google Scholar 

  69. 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 Aug 18; 353(7): 663–70

    Article  PubMed  CAS  Google Scholar 

  70. Kastrati A, Mehilli J, von Beckerath N, et al. Sirolimuseluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. JAMA 2005 Jan 12; 293(2): 165–71

    Article  PubMed  CAS  Google Scholar 

  71. Mehilli J, Dibra A, Kastrati A, et al. Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels. Eur Heart J 2006 Feb; 27(3): 260–6

    Article  PubMed  CAS  Google Scholar 

  72. Song F, Altman DG, Glenny AM, et al. Validity of indirect comparison for estimating efficacy of competing interventions: empirical evidence from published metaanalyses. BMJ 2003 Mar 1; 326(7387): 472

    Article  PubMed  Google Scholar 

  73. Bucher HC, Guyatt GH, Griffith LE, et al. The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol 1997 Jun; 50(6): 683–91

    Article  PubMed  CAS  Google Scholar 

  74. McFadden EP, Stabile E, Regar E, et al. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet 2004 Oct 23–29; 364(9444): 1519–21

    Article  PubMed  CAS  Google Scholar 

  75. Iakovou I, Schmidt T, Bonizzoni E, et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 2005 May 4; 293(17): 2126–30

    Article  PubMed  CAS  Google Scholar 

  76. Fujii K, Carlier SG, Mintz GS, et al. Stent underexpansion and residual reference segment stenosis are related to stent thrombosis after sirolimus-eluting stent implantation: an intravascular ultrasound study. J Am Coll Cardiol 2005 Apr 5; 45(7): 995–8

    Article  PubMed  CAS  Google Scholar 

  77. Kastrati A. Drug for a while, polymer for life: is it a good solution? Catheter Cardiovasc Interv 2008 Feb 15; 71(3): 340–1

    Article  PubMed  Google Scholar 

  78. 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 Mar 8; 356(10): 1009–19

    Article  PubMed  CAS  Google Scholar 

  79. James SK, Stenestrand U, Lindback J, et al. Long-term safety and efficacy of drug-eluting versus bare-metal stents in Sweden. N Engl J Med 2009 May 7; 360(19): 1933–45

    Article  PubMed  CAS  Google Scholar 

  80. Daemen J, Simoons ML, Wijns W, et al. Meeting report: ESC Forum on drug eluting stents. European Heart House, Nice, 27–28 September 2007. Eur Heart J 2009 Jan; 30(2): 152–61

    PubMed  Google Scholar 

  81. Spaulding C, Daemen J, Boersma E, et al. A pooled analysis of data comparing sirolimus-eluting stents with baremetal stents. N Engl J Med 2007 Mar 8; 356(10): 989–97

    Article  PubMed  CAS  Google Scholar 

  82. Indolfi C, Pavia M, Angelillo IF. Drug-eluting stents versus bare metal stents in percutaneous coronary interventions (a meta-analysis). Am J Cardiol 2005 May 15; 95(10): 1146–52

    Article  PubMed  CAS  Google Scholar 

  83. 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 Mar 17; 43(6): 1110–5

    Article  PubMed  CAS  Google Scholar 

  84. Schofer J, Schluter M, Gershlick AH, et al. Sirolimuseluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet 2003 Oct 4; 362(9390): 1093–9

    Article  PubMed  CAS  Google Scholar 

  85. Mauri L, Hsieh WH, Massaro JM, et al. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med 2007 Mar 8; 356(10): 1020–9

    Article  PubMed  CAS  Google Scholar 

  86. Gershlick A, Kandzari DE, Leon MB, et al. Zotarolimuseluting stents in patients with native coronary artery disease: clinical and angiographic outcomes in 1317 patients. Am J Cardiol 2007 Oct 22; 100(8B): 45–55M

    Article  CAS  Google Scholar 

  87. Wenaweser P, Daemen J, Zwahlen M, et al. Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice: 4-year results from a large 2-institutional cohort study. J Am Coll Cardiol 2008 Sep 30; 52(14): 1134–40

    Article  PubMed  CAS  Google Scholar 

  88. Williams DO, Abbott JD, Kip KE. Outcomes of 6906 patients undergoing percutaneous coronary intervention in the era of drug-eluting stents: report of the DEScover Registry. Circulation 2006 Nov 14; 114(20): 2154–62

    Article  PubMed  Google Scholar 

  89. Abbott JD, Voss MR, Nakamura M, et al. Unrestricted use of drug-eluting stents compared with bare-metal stents in routine clinical practice: findings from the National Heart, Lung, and Blood Institute Dynamic Registry. J Am Coll Cardiol 2007 Nov 20; 50(21): 2029–36

    Article  PubMed  CAS  Google Scholar 

  90. Jensen LO, Maeng M, Kaltoft A, et al. Stent thrombosis, myocardial infarction, and death after drug-eluting and bare-metal stent coronary interventions. J Am Coll Cardiol 2007 Jul 31; 50(5): 463–70 769

    Article  PubMed  CAS  Google Scholar 

  91. 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) multicenter registry. Circulation 2007 Jun 26; 115(25): 3181–8

    Article  PubMed  CAS  Google Scholar 

  92. Tu JV, Bowen J, Chiu M, et al. Effectiveness and safety of drug-eluting stents in Ontario. N Engl J Med 2007 Oct 4; 357(14): 1393–402

    Article  PubMed  CAS  Google Scholar 

  93. Shishehbor MH, Goel SS, Kapadia SR, et al. Long-term impact of drug-eluting stents versus bare-metal stents on all-cause mortality. J Am Coll Cardiol 2008 Sep 23; 52(13): 1041–8

    Article  PubMed  CAS  Google Scholar 

  94. Cook S, Wenaweser P, Togni M, et al. Incomplete stent apposition and very late stent thrombosis after drugeluting stent implantation. Circulation 2007 May 8; 115(18): 2426–34

    Article  PubMed  CAS  Google Scholar 

  95. Finn AV, Nakazawa G, Joner M, et al. Vascular responses to drug eluting stents: importance of delayed healing. Arterioscler Thromb Vasc Biol 2007 Jul; 27(7): 1500–10

    Article  PubMed  CAS  Google Scholar 

  96. Steg PG, Fox KA, Eagle KA, et al. Mortality following placement of drug-eluting and bare-metal stents for ST-segment elevation acute myocardial infarction in the Global Registry of Acute Coronary Events. Eur Heart J 2009 Feb; 30(3): 321–9

    Article  PubMed  Google Scholar 

  97. Mauri L, Silbaugh TS, Garg P, et al. Drug-eluting or baremetal stents for acute myocardial infarction. N Engl J Med 2008 Sep 25; 359(13): 1330–42

    Article  PubMed  CAS  Google Scholar 

  98. Menichelli M, Parma A, Pucci E, et al. Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI). J Am Coll Cardiol 2007 May 15; 49(19): 1924–30

    Article  PubMed  CAS  Google Scholar 

  99. Spaulding C, Henry P, Teiger E, et al. Sirolimus-eluting versus uncoated stents in acute myocardial infarction. N Engl J Med 2006 Sep 14; 355(11): 1093–104

    Article  PubMed  CAS  Google Scholar 

  100. Valgimigli M, Campo G, Percoco G, et al. Comparison of angioplasty with infusion of tirofiban or abciximab and with implantation of sirolimus-eluting or uncoated stents for acute myocardial infarction: the MULTISTRATEGY randomized trial. JAMA 2008 Apr 16; 299(15): 1788–99

    Article  PubMed  CAS  Google Scholar 

  101. Valgimigli M, Percoco G, Malagutti P, et al. Tirofiban and sirolimus-eluting stent vs abciximab and bare-metal stent for acute myocardial infarction: a randomized trial. JAMA 2005 May 4; 293(17): 2109–17

    Article  PubMed  Google Scholar 

  102. van der Hoeven BL, Liem SS, Jukema JW, et al., on behalf of the Intervention Study. Sirolimus-eluting stents versus bare-metal stents in patients with ST-segment elevation myocardial infarction: 9-month angiographic and intravascular ultrasound results and 12-month clinical outcome results from the MISSION! J Am Coll Cardiol 2008 Feb 12; 51(6): 618–26

    Article  PubMed  CAS  Google Scholar 

  103. Laarman GJ, Suttorp MJ, Dirksen MT, et al. Paclitaxeleluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med 2006 Sep 14; 355(11): 1105–13

    Article  PubMed  CAS  Google Scholar 

  104. Stone GW, Lansky AJ, Pocock SJ, et al. Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction. N Engl J Med 2009 May 7; 360(19): 1946–59

    Article  PubMed  CAS  Google Scholar 

  105. Iijima R, Ndrepepa G, Mehilli J, et al. Impact of diabetes mellitus on long-term outcomes in the drug-eluting stent era. Am Heart J 2007 Oct; 154(4): 688–93

    Article  PubMed  CAS  Google Scholar 

  106. Roy P, Okabe T, Pinto Slottow TL, et al. Correlates of clinical restenosis following intracoronary implantation of drugeluting stents. Am J Cardiol 2007 Sep 15; 100(6): 965–9

    Article  PubMed  Google Scholar 

  107. Buch AN, Javaid A, Steinberg DH, et al. Outcomes after sirolimus- and paclitaxel-eluting stent implantation in patients with insulin-treated diabetes mellitus. Am J Cardiol 2008 May 1; 101(9): 1253–8

    Article  PubMed  CAS  Google Scholar 

  108. Stankovic G, Cosgrave J, Chieffo A, et al. Impact of sirolimus-eluting and paclitaxel-eluting stents on outcome in patients with diabetes mellitus and stenting in more than one coronary artery. Am J Cardiol 2006 Aug 1; 98(3): 362–6

    Article  PubMed  CAS  Google Scholar 

  109. Daemen J, Garcia-Garcia HM, Kukreja N, et al. The longterm value of sirolimus- and paclitaxel-eluting stents over bare metal stents in patients with diabetes mellitus. Eur Heart J 2007 Jan; 28(1): 26–32

    Article  PubMed  CAS  Google Scholar 

  110. Garg P, Normand SL, Silbaugh TS, et al. Drug-eluting or bare-metal stenting in patients with diabetes mellitus: results from the Massachusetts Data Analysis Center Registry. Circulation 2008 Nov 25; 118(22): 2277–85

    Article  PubMed  CAS  Google Scholar 

  111. Kaiser C, Brunner-La Rocca HP, Buser PT, et al. Incremental cost-effectiveness of drug-eluting stents compared with a third-generation bare-metal stent in a real-world setting: randomised Basel Stent Kosten Effektivitats Trial (BASKET). Lancet 2005 Sep 10–16; 366(9489): 921–9

    Article  PubMed  CAS  Google Scholar 

  112. Cohen DJ, Bakhai A, Shi C, et al. Cost-effectiveness of sirolimus-eluting stents for treatment of complex coronary stenoses: results from the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions (SIRIUS) trial. Circulation 2004 Aug 3; 110(5): 508–14

    Article  PubMed  Google Scholar 

  113. NICE technology appraisal guidance. 152 drug-eluting stents for the treatment of coronary artery disease [online]. Available from URL: http://www.nice.org.uk/Guidance/TA152 [Accessed 2009 Aug 4]}

  114. Elezi S, Dibra A, Folkerts U, et al. Cost analysis from two randomized trials of sirolimus-eluting stents versus paclitaxeleluting stents in high-risk patients with coronary artery disease. J Am Coll Cardiol 2006 Jul 18; 48(2): 262–7

    Article  PubMed  CAS  Google Scholar 

  115. 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 Jun 5; 115(22): 2842–7

    Article  PubMed  Google Scholar 

  116. Chen MS, John JM, Chew DP, et al. Bare metal stent restenosis is not a benign clinical entity. Am Heart J 2006 Jun; 151(6): 1260–4

    Article  PubMed  Google Scholar 

  117. Garg P, Cohen DJ, Gaziano T, et al. Balancing the risks of restenosis and stent thrombosis in bare-metal versus drugeluting stents: results of a decision analytic model. J Am Coll Cardiol 2008 May 13; 51(19): 1844–53

    Article  PubMed  CAS  Google Scholar 

  118. King III SB, Smith Jr SC, Hirshfeld Jr 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 Guidelines: 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 Jan 15; 117(2): 261–95 770

    Article  PubMed  Google Scholar 

  119. Byrne RA, Kastrati A. Duration of antiplatelet therapy following intracoronary stenting: are changes needed? Eur Heart J suppl 2008; 10 Suppl. I: I25–9

    Article  Google Scholar 

  120. 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 Aug 14; 116(7): 745–54

    Article  PubMed  CAS  Google Scholar 

  121. Eisenstein EL, Anstrom KJ, Kong DF, et al. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA 2007 Jan 10; 297(2): 159–6

    Article  PubMed  CAS  Google Scholar 

  122. Byrne RA, Schulz S, Mehilli J, et al. Rationale and design of a randomized, double-blind, placebo-controlled trial of 6 versus 12 months clopidogrel therapy after implantation of a drug-eluting stent: The Intracoronary Stenting and Antithrombotic Regimen: Safety And Efficacy of 6 Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE) study. Am Heart J 2009 Apr;157(4): 620–4

    Article  PubMed  CAS  Google Scholar 

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Aknowledgements

Robert A. Byrne was supported by a Research Fellowship in Atherothrombosis from the European Society of Cardiology. The funding authority had no input into the manuscript preparation. ## Adnan Kastrati reports having received lecture fees from Bristol-Myers, Cordis, Lilly and sanofi-aventis. The other authors have no conflicts of interest that are directly relevant to the content of this review.

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  1. Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität, Lazarettstrasse 36, 80636, Munich, Germany

    Robert A. Byrne, Nikolaus Sarafoff, Adnan Kastrati &  Albert Schömig

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Byrne, R.A., Sarafoff, N., Kastrati, A. et al. Drug-Eluting Stents in Percutaneous Coronary Intervention. Drug-Safety 32, 749–770 (2009). https://doi.org/10.2165/11316500-000000000-00000

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