American Journal of Cardiology
Volume 102, Issue 12 , Pages 1624-1630 , 15 December 2008

Overview of the 2007 Food and Drug Administration Circulatory System Devices Panel Meeting on the Xience V Everolimus-Eluting Coronary Stent

Received 30 July 2008 ,Revised 7 August 2008 ,Accepted 7 August 2008.

References 

  1. 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
  2. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, 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
  3. 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;27:2784–2814
  4. Lagerqvist B, James SK, Stenestrand U, Lindback J, Nilsson T, Wallentin L. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med. 2007;356:1009–1019
  5. Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, et al Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005;293:2126–2130
  6. Pfisterer M, Brunner-La Rocca HP, Buser PT, Rickenbacher P, Hunziker P, Mueller C, 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
  7. Lopez-Minguez JR, Nogales JM, Morales A, Alonso R, Gonzalez R, Merchan A. Clinical and angiographic follow-up in patients with Cypher or Taxus stents in populations with high percentage of trial-excluded lesions. Cardiovasc Revasc Med. 2005;6:92–98
  8. Roy P, Buch AN, Javaid A, Okabe T, Raya V, Pinto Slottow TL, et al Impact of “off-label” utilization of drug-eluting stents on clinical outcomes in patients undergoing percutaneous coronary intervention. Am J Cardiol. 2008;101:293–299
  9. Roy P, Okabe T, Pinto Slottow TL, Steinberg DH, Smith K, Torguson R, et al Correlates of clinical restenosis following intracoronary implantation of drug-eluting stents. Am J Cardiol. 2007;100:965–969
  10. Cosgrave J, Agostoni P, Ge L, Iakovou I, Chieffo A, Biondi-Zoccai GG, et al Clinical outcome following aleatory implantation of paclitaxel-eluting or sirolimus-eluting stents in complex coronary lesions. Am J Cardiol. 2005;96:1663–1668
  11. Boam A, Kozeli D. Guidance for industry coronary drug-eluting stents—nonclinical and clinical studies. http://www.fda.gov/cdrh/ode/guidance/6255comp.pdfAccessed May 2, 2008
  12. Johnson G, Simhambhatla M, Coleman L, Stone G, Krucoff M, Sudhir K. Xience V everolimus-eluting coronary stent system: Abbott Vascular presentation. Presented at: FDA Circulatory System Device Panel meeting; November 29, 2007; Gaithersburg, Maryland. Available at: http://www.fda.gov/ohrms/dockets/ac/07/slides/2007-4333s1-02%20-FDA%20Presentation%20v3.pdf. Accessed May 2, 2008.
  13. Agler H, Fiorentino R, Yan X, Duggirala H. Xience V everolimus-eluting coronary stent system: FDA review. Presented at: FDA Circulatory System Device Panel meeting; November 29, 2007; Gaithersburg, Maryland.
  14. Serruys PW, Ong ATL, Piek J, Neumann F-J, van der Giessen WJ, Wiemer M, 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
  15. Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, 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
  16. Ellis SG, Colombo A, Grube E, Popma J, Koglin J, Dawkins KD, et al. Incidence, timing, and correlates of stent thrombosis with the polymeric paclitaxel drug-eluting stent: a TAXUS II, IV, V, and VI meta-analysis of 3,445 patients followed for up to 3 years. J Am Coll Cardiol. 2007;49:1043–1051
  17. Mauri L, Hsieh WH, Massaro JM, Ho KK, D'Agostino R, Cutlip DE. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med. 2007;356:1020–1029
  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. Pocock SJ, Lansky AJ, Mehran R, Popma JJ, Fahy MP, Na Y, 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;51:23–32

PII: S0002-9149(08)01387-8

doi: 10.1016/j.amjcard.2008.08.013

American Journal of Cardiology
Volume 102, Issue 12 , Pages 1624-1630 , 15 December 2008