American Heart Journal
Volume 157, Issue 1 , Pages 125-131 , January 2009

The use of intravenous enoxaparin in elective percutaneous coronary intervention in patients with renal impairment: Results from the SafeTy and Efficacy of Enoxaparin in PCI patients, an internationaL randomized Evaluation (STEEPLE) trial

  • Harvey D. White, MB, ChB, DSc

      Affiliations

    • Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand
    • Corresponding Author InformationReprint requests: Harvey White, DSc, Green Lane Cardiovascular Service, Auckland City Hospital, Private Bag 92024, 1030 Auckland, New Zealand.
    • ,
  • Richard Gallo, MD

      Affiliations

    • Montreal Heart Institute, Université de Montréal, Montréal, Québec, Canada
    • ,
  • Marc Cohen, MD

      Affiliations

    • Division of Cardiology, Newark Beth Israel Medical Center, Newark, NJ
    • ,
  • Ph. Gabriel Steg, MD

      Affiliations

    • Service de Cardiologie, Hôpital Bichat, Paris, France
    • ,
  • Philip E. Aylward, MB, ChB, PhD

      Affiliations

    • Department of Cardiology, Flinders Medical Center, Adelaide, South Australia, Australia
    • ,
  • Christoph Bode, MD, PhD

      Affiliations

    • Abteilung Innere Medizin III, Universitätsklinikum Freiburg, Freiburg, Germany
    • ,
  • Steve Steinhubl, MD

      Affiliations

    • The Adjunct Faculty, Geisinger Clinic, Geisinger Center for Health Research, Danville, PA
    • ,
  • Gilles Montalescot, MD, PhD

      Affiliations

    • Institut de Cardiologie (AP-HP) and INSERM Unit #856 Centre Hospitalier Universitaire Pitié-Salpêtrière, Paris, France

Received 15 May 2008 ,Accepted 20 August 2008.

References 

  1. Popma JJ, Berger P, Ohman EM, et al. Antithrombotic therapy during percutaneous coronary intervention: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(3 Suppl):576S–599S
  2. Choussat R, Montalescot G, Collet JP, et al. A unique, low dose of intravenous enoxaparin in elective percutaneous coronary intervention. J Am Coll Cardiol. 2002;40:1943–1950
  3. Miller L, Gupta A, Bertolet BD. Use of clopidogrel loading, enoxaparin, and double-bolus eptifibatide in the setting of early percutaneous coronary intervention for acute coronary syndromes. J Invasive Cardiol. 2002;14:247–250
  4. Kereiakes DJ, Grines CL, Fry E, et al. Enoxaparin and abciximab adjunctive pharmacotherapy during percutaneous coronary intervention. J Invasive Cardiol. 2001;13:272–278
  5. Bhatt DL, Lee BI, Casterella PJ, et al. Safety of concomitant therapy with eptifibatide and enoxaparin in patients undergoing percutaneous coronary intervention: results of the Coronary Revascularization Using Integrilin and Single bolus Enoxaparin Study. J Am Coll Cardiol. 2003;41:20–25
  6. Galeote G, Hussein M, Sobrino N, et al. Use of a combination of enoxaparin or unfractionated heparin and abciximab during percutaneous coronary interventions: a randomized pilot study. Rev Esp Cardiol. 2002;55:1261–1266[Article in Spanish]
  7. Madan M, Radhakrishnan S, Reis M, et al. Comparison of enoxaparin versus heparin during elective percutaneous coronary intervention performed with either eptifibatide or tirofiban (the ACTION Trial). Am J Cardiol. 2005;95:1295–1301
  8. Montalescot G, Collet JP, Tanguy ML, et al. Anti-Xa activity relates to survival and efficacy in unselected acute coronary syndrome patients treated with enoxaparin. Circulation. 2004;110:392–398
  9. Hirsh J, Warkentin TE, Shaughnessy SG, et al. Heparin and low-molecular-weight heparin: mechanisms of action, pharmacokinetics, dosing, monitoring, efficacy, and safety. Chest. 2001;119(1 Suppl):64S–94S
  10. Becker RC, Spencer FA, Gibson M, et al. Influence of patient characteristics and renal function on factor Xa inhibition pharmacokinetics and pharmacodynamics after enoxaparin administration in non–ST-segment elevation acute coronary syndromes. Am Heart J. 2002;143:753–759
  11. Chow SL, Zammit K, West K, et al. Correlation of antifactor Xa concentrations with renal function in patients on enoxaparin. J Clin Pharmacol. 2003;43:586–590
  12. Sanderink GJ, Guimart CG, Ozoux ML, et al. Pharmacokinetics and pharmacodynamics of the prophylactic dose of enoxaparin once daily over 4 days in patients with renal impairment. Thromb Res. 2002;105:225–231
  13. Hirsh J, Raschke R. Heparin and low-molecular-weight-heparin: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004;126(3 Suppl):188S–203S
  14. Montalescot G, White HD, Gallo R, et al. Enoxaparin versus unfractionated heparin in elective percutaneous coronary intervention. N Eng J Med. 2006;355:1006–1017
  15. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31–41
  16. Lim W, Dentali F, Eikelboom JW, et al. Meta-analysis: low-molecular-weight heparin and bleeding in patients with severe renal insufficiency. Ann Intern Med. 2006;144:673–684
  17. Thorevska N, Amoateng-Adjepong Y, Sabahi R, et al. Anticoagulation in hospitalized patients with renal insufficiency: a comparison of bleeding rates with unfractionated heparin vs enoxaparin. Chest. 2004;125:856–863
  18. Fox KA, Antman EM, Montalescot G, et al. The impact of renal dysfunction on outcomes in the ExTRACT-TIMI 25 trial. J Am Coll Cardiol. 2007;49:2249–2255
  19. Brophy DF, Wazny LD, Gehr TW, et al. The pharmacokinetics of subcutaneous enoxaparin in end-stage renal disease. Pharmacotherapy. 2001;21:169–174
  20. Integrilin (Eptifibatide) [package insert]. San Francisco (CA): Millennium Pharmaceuticals; 2003;
  21. Tirofiban . [package insert]. Whitehouse Station (NJ): Merck & Co; 2002;

 Registered trial no. NCT00077844.

 The STEEPLE trial was funded by Sanofi Aventis (Paris, France). Dr White reports receiving grant support, consulting fees, and lecture fees from Sanofi Aventis and The Medicines Company (Parsippany, NJ), and grant support from Proctor and Gamble (Cincinnati, OH), Alexion (Cheshire, CT), Schering Plough (Kenilworth, NJ), and Eli Lilly (Indianapolis, IN). Dr Gallo reports having received grant support, consulting fees, and lecture fees from Sanofi Aventis; lecture fees from Abbott Interventional (Chicago, IL), Oryx Pharmaceuticals (Mississauga, Ontario, Canada), and Biovail Pharmaceuticals (Mississauga, Ontario, Canada); and consulting fees from Biovail Pharmaceuticals. Dr Cohen reports receiving grant support from Aventis Pharmaceuticals (Strasbourg, France), consulting fees from Sanofi Aventis and AstraZeneca (London, United Kingdom), and lecture fees from Sanofi Aventis, Merck (Whitehouse Station, NJ), and Schering (Berlin-Wedding, Germany). Dr Steg reports receiving grant support from Sanofi Aventis; consulting fees from Sanofi-Aventis, Takeda (Osaka, Japan), AstraZeneca, Bristol-Myers Squibb (New York, NY), Endotis (Romainville, France), Lilly, Merck Sharpe & Dohme (Whitehouse Station, NJ), GlaxoSmithKline (London, United Kingdom), Pfizer (New York, NY), Servier (Neuilly-sur-Seine, France), The Medicines Company; and speakers bureau from AstraZeneca, Boehringer Ingelheim (Ingelheim, Germany), Bristol-Myers Squibb, GlaxoSmithKline, Merck Sharpe & Dohme, Novartis (Basel, Switzerland), Nycomed (Zurich, Switzerland), Sanofi Aventis, Sankyo (Tokyo, Japan), Servier, The Medicines Company, and ZLB Behring (West Sussex, United Kingdom). Dr Aylward reports receiving grant support from Sanofi Aventis, Proctor and Gamble, Alexion, The Medicines Company, Schering Plough, and Eli Lilly, as well as consulting fees and lecture fees from Sanofi Aventis and Bristol-Myers Squibb. Dr Bode reports receiving consulting and lecture fees from Sanofi Aventis, Lilly, and GlaxoSmithKline; consulting fees from Nycomed; and lecture fees from AstraZeneca. Dr Steinhubl is currently employed by The Medicines Company; before this appointment, Dr Steinhubl reports receiving consulting fees from Sanofi-Aventis, The Medicines Company, AstraZeneca, Eli Lilly, Cardax Pharmaceuticals (Aiea, HI), and Daiichi Sankyo. Dr Montalescot reports receiving grant support, consulting fees, and lecture fees from Sanofi Aventis, Eli Lilly, and Bristol-Myers Squibb; consulting and lecture fees from Schering-Plough and The Medicines Company; and lecture fees from GlaxoSmithKline.

PII: S0002-8703(08)00734-5

doi: 10.1016/j.ahj.2008.08.019

American Heart Journal
Volume 157, Issue 1 , Pages 125-131 , January 2009

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