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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
References
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- . 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
- . Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med. 2007;356:1009–1019
- Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005;293:2126–2130
- . 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
- . 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
- 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
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- Clinical outcome following aleatory implantation of paclitaxel-eluting or sirolimus-eluting stents in complex coronary lesions. Am J Cardiol. 2005;96:1663–1668
- . Guidance for industry coronary drug-eluting stents—nonclinical and clinical studies. http://www.fda.gov/cdrh/ode/guidance/6255comp.pdfAccessed May 2, 2008
- 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.
- 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.
- 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
- 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
- . 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
- . Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med. 2007;356:1020–1029
- Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med. 2007;356:998–1008
- 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
© 2008 Elsevier Inc. All rights reserved.
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American Journal of Cardiology
Volume 102, Issue 12
, Pages 1624-1630
, 15 December 2008
