American Journal of Cardiology
Volume 102, Issue 9, Supplement , Pages 12J-17J , 3 November 2008

The Question of Drug-Eluting Stent Safety: Then and Now

  • Christian Spaulding, MD

      Affiliations

    • Corresponding Author InformationAddress for reprints: Christian Spaulding, MD, Cardiology Department, Cochin Hospital, René Descartes University, 27 Rue du Fg St. Jacques, 75014, Paris, France

References 

  1. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, et al. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions: a randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346:1773–1780
  2. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, 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
  3. Schofer J, Schlüter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, et al. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet. 2003;362:1093–1099
  4. Schampaert E, Cohen EA, Schlüter M, Reeves F, Traboulsi M, Title LM, 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
  5. Grube E, Silber S, Hauptmann KE, Mueller R, Buellesfeld L, Gerckens U, 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
  6. Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, 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
  7. Tanabe K, Serruys PW, Grube E, Smits PC, Selbach G, van der Giessen WJ, et al TAXUS III Trial: in-stent restenosis treated with stent-based delivery of paclitaxel incorporated in a slow-release polymer formulation. Circulation. 2003;107:559–564
  8. Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, et al. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004;350:221–231
  9. Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D, 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;294:1215–1223
  10. Dawkins KD, Grube E, Guagliumi G, Banning AP, Zmudka K, Colombo A, 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
  11. McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, et al Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004;364:1519–1521
  12. Kotani J, Awata M, Nanto S, Uematsu M, Oshima F, Minamiguchi H, et al. Incomplete neointimal coverage of sirolimus-eluting stents: angioscopic findings. J Am Coll Cardiol. 2006;47:2108–2111
  13. Camenzind E, Steg PG, Wijns W. Safety of drug-eluting stents: insights from meta analysis. Presented at the European Society of Cardiology Annual Congress; September 2-6 2006;Barcelona, Spain. Hotline I; 707009
  14. Reuters. Cardiologists question the risks in using drug-coated stents. New York Times; September 5, 2006 http://www.nytimes.com/2006/09/05/business/worldbusiness/05stents.htmlAccessed January 28, 2008
  15. Feder BJ. Newer stents pose dangers, 2 doctors say. New York Times; October 12, 2006 http://www.nytimes.com/2006/10/12/health/12stent.htmlAccessed January 28, 2008
  16. US drug-eluting stent market set to grow to $3 billion by 2011, despite short-term decline [press release]. Waltham, Massachusetts: Millennium Research Group, MRG News; February 26, 2007 http://www.mrg.net/news_newwin.php?news_id=209Accessed January 28, 2008
  17. US Food and Drug Administration. Update to FDA statement on coronary drug-eluting stents. 2007;http://www.fda.gov/cdrh/news/010407.htmlAccessed January 28, 2008
  18. Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice MC, et al Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med. 2007;356:998–1008
  19. Spaulding C, Daemen J, Boersma E, Cutlip DE, Serruys PW. A pooled analysis comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med. 2007;356:989–997
  20. Kastrati A, Mehilli J, Pache J, Kaiser C, Valgimigli M, Kelbaek H, et al Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med. 2007;356:1030–1039
  21. Lagerqvist B, James SK, Stenestrand U, Lindbäck J, Nilsson T, Wallentin L SCAAR Study Group. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med. 2007;356:1009–1019
  22. James S, Carlsson J, Lindbäck J, Nilsson T, Stenestrand U, Wallentin L, et al. Long term mortality after drug eluting stents in Sweden: an additional year of follow-up. Presented at the European Society of Cardiology Annual Congress; September 1–5 2007;Vienna, Austria. Clinical trial update I; 1021
  23. Tu JV, Bowen J, Chiu M, Ko DT, Austin PC, He Y, et al. Effectiveness and safety of drug-eluting stents in Ontario. N Engl J Med. 2007;357:1393–1402
  24. Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, 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
  25. Stettler C, Wandel S, Allemann S, Kastrati A, Morice M, Schömig A, et al Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007;370:937–948
  26. Stone GW, Ellis SG, Colombo A, Dawkins KD, Grube E, Cutlip DE, 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
  27. King SB, Smith SC, Hirshfeld JW, Jacobs AK, Morrison DA, Williams DO 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. 2007 Focused update of the ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention. Circulation. 2008;117:261–295

 Statement of author disclosure: Please see the Author Disclosures section at the end of this article.

PII: S0002-9149(08)01493-8

doi: 10.1016/j.amjcard.2008.09.004

American Journal of Cardiology
Volume 102, Issue 9, Supplement , Pages 12J-17J , 3 November 2008

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