American Heart Journal
Volume 157, Issue 5 , Pages 811-817.e1 , May 2009

Efficacy of Xience/promus versus Cypher in rEducing Late Loss after stENTing (EXCELLENT) trial: Study design and rationale of a Korean multicenter prospective randomized trial

  • Kyung Woo Park, MD

      Affiliations

    • Cardiovascular Center, Seoul National University Main Hospital, Seoul, South Korea
  • ,
  • Jung-Han Yoon, MD

      Affiliations

    • Yonsei University Wonju Severance Hospital, Wonju, South Korea
  • ,
  • Jung-Sun Kim, MD

      Affiliations

    • Yonsei University Severance Hospital, Seoul, South Korea
  • ,
  • Joo-Yong Hahn, MD

      Affiliations

    • Sung-Kyun-Kwan University Samsung Medical Center, Seoul, South Korea
  • ,
  • Young-Seok Cho, MD

      Affiliations

    • Seoul National University Bundang Hospital, Sungnam, South Korea
  • ,
  • In-Ho Chae, MD

      Affiliations

    • Seoul National University Bundang Hospital, Sungnam, South Korea
  • ,
  • Hyeon-Cheol Gwon, MD

      Affiliations

    • Sung-Kyun-Kwan University Samsung Medical Center, Seoul, South Korea
  • ,
  • Taehoon Ahn, MD

      Affiliations

    • Gachon University Gil Medical Center, Incheon, South Korea
  • ,
  • Byung-Hee Oh, MD

      Affiliations

    • Cardiovascular Center, Seoul National University Main Hospital, Seoul, South Korea
  • ,
  • Jeong-Euy Park, MD

      Affiliations

    • Sung-Kyun-Kwan University Samsung Medical Center, Seoul, South Korea
  • ,
  • Won-Heum Shim, MD

      Affiliations

    • Yonsei University Severance Hospital, Seoul, South Korea
  • ,
  • Eak-Kyun Shin, MD

      Affiliations

    • Gachon University Gil Medical Center, Incheon, South Korea
  • ,
  • Yang-Soo Jang, MD

      Affiliations

    • Yonsei University Severance Hospital, Seoul, South Korea
    • Corresponding Author InformationReprint requests: Hyo-Soo Kim, MD, PhD / Yang-Soo Jang, MD, PhD, Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital/Yonsei University Severance Hospital, 28 Yongon-dong Chongno-gu, Seoul 110-744, South Korea.
  • ,
  • Hyo-Soo Kim, MD

      Affiliations

    • Cardiovascular Center, Seoul National University Main Hospital, Seoul, South Korea
    • Corresponding Author InformationReprint requests: Hyo-Soo Kim, MD, PhD / Yang-Soo Jang, MD, PhD, Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital/Yonsei University Severance Hospital, 28 Yongon-dong Chongno-gu, Seoul 110-744, South Korea.

Received 16 August 2008 ,Accepted 10 February 2009.

References 

  1. Costa RA, Lansky AJ, Mintz GS, et al. Angiographic results of the first human experience with everolimus-eluting stents for the treatment of coronary lesions (the FUTURE I trial). Am J Cardiol. 2005;95:113–116
  2. Serruys PW, Ong ATL, Piek JJ, et al. A randomized comparison of a durable polymer everolimus-eluting stent with a bare metal coronary stent: the SPIRIT FIRST trial. Eurointervention. 2005;1:58–65
  3. Serruys PW, Ruygrok P, Neuzner J, et al. A randomized comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent: the SPIRIT II trial. Eurointervention. 2006;2:286–294
  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. 2008;299:1903–1913
  5. Windecker S, Remondino A, Eberli FR, et al. Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization. N Engl J Med. 2005;353:653–662
  6. 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
  7. Goy JJ, Stauffer JC, Siegenthaler M, et al. 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
  8. 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
  9. 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
  10. Grines CL, Bonow RO, Casey DE, et al. Prevention of premature discontinuation of dual antiplatelet therapy in patients with coronary artery stents: a science advisory from the AHA, ACC SCAI, ACS, and ADA, with representation from the ACP. Circulation. 2007;115:813–818
  11. 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
  12. Camenzind E, Steg PG, Wijns W. Stent thrombosis late after implantation of first-generation drug-eluting stents: a cause for concern. Circulation. 2007;115:1440–1455
  13. 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
  14. Schofer J, Schlüter M, Gershlick AH, 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
  15. Schampaert E, Cohen EA, Schlüter 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
  16. Stone GW, Moses JW, Ellis SG, et al. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med. 2007;356:998–1008
  17. Sousa JE, Costa MA, Abizaid A, et al. Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries. Circulation. 2001;103:192–195
  18. Morice MC, Serruys PW, Sousa JE, 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
  19. Carter AJ, Brodeur A, Collingwood R, et al. Experimental efficacy of an everolimus eluting cobalt chromium stent. Catheter Cardiovasc Interv. 2006;68:97–103
  20. Sakamoto H, Ishikawa T, Mutoh M, et al. Effectiveness of a sirolimus-eluting stent (Cypher) for diffuse in-stent restenosis inside a bare metal stent. Int Heart J. 2006;47:651–661
  21. Ge L, Iakovou I, Cosgrave J, et al. Immediate and mid-term outcomes of sirolimus-eluting stent implantation for chronic total occlusions. Eur Heart J. 2005;26:1056–1062
  22. Sheiban I, Villata G, Bollati M, et al. Next-generation drug-eluting stents in coronary artery disease: focus on everolimus-eluting stent (Xience V). Vasc Health Risk Manag. 2008;4:31–38
  23. Wessely R, Schömig A, Kastrati A. Sirolimus and paclitaxel on polymer-based drug-eluting stents: similar but different. J Am Coll Cardiol. 2006;47:708–714
  24. 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 observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol. 2006;48:2584–2591
  25. Mehta SR, Yusuf S, Peters RJ, et al. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet. 2001;358:527–533
  26. Steinhubl SR, Berger PB, Mann JT, et al. Clopidogrel for the reduction of events during observation. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA. 2002;288:2411–2420
  27. Eisenstein EL, Anstrom KJ, Kong DF, et al. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA. 2007;297:159–168

 ClinicalTrials.gov identifier: NCT00698607.

PII: S0002-8703(09)00134-3

doi: 10.1016/j.ahj.2009.02.008

American Heart Journal
Volume 157, Issue 5 , Pages 811-817.e1 , May 2009