American Heart Journal
Volume 158, Issue 5 , Pages 726-733 , November 2009

Design and rationale of the Evaluation of M118 IN pErcutaNeous Coronary intErvention (EMINENCE) trial

  • Chiara Melloni, MD, MHS

      Affiliations

    • Duke Clinical Research Institute, Durham, NC
    • Corresponding Author InformationReprint requests: Chiara Melloni, MD, MHS, 2400 Pratt St., Durham, NC, 27705.
  • ,
  • Ian Fier, MBA

      Affiliations

    • Momenta Pharmaceuticals, Cambridge, MA
  • ,
  • James Roach, MD

      Affiliations

    • Momenta Pharmaceuticals, Cambridge, MA
  • ,
  • Andrzej S. Kosinski, PhD

      Affiliations

    • Duke Clinical Research Institute, Durham, NC
  • ,
  • Samuel Broderick, MS

      Affiliations

    • Duke Clinical Research Institute, Durham, NC
  • ,
  • Kristina Sigmon, MA, MS

      Affiliations

    • Duke Clinical Research Institute, Durham, NC
  • ,
  • Shelley Myles, BSc, RN

      Affiliations

    • Duke Clinical Research Institute, Durham, NC
  • ,
  • Richard C. Becker, MD

      Affiliations

    • Duke Clinical Research Institute, Durham, NC
  • ,
  • Sunil V. Rao, MD

      Affiliations

    • Duke Clinical Research Institute, Durham, NC
  • ,
  • on behalf of the EMINENCE Investigators

Received 12 June 2009 ,Accepted 25 August 2009.

References 

  1. Hirsh J, Guyatt G, Albers GW, et al. Executive summary: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest. 2008;133:71S–109S
  2. Smith SC, Feldman TE, Hirshfeld JW, et al. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention. Circulation. 2006;113:e166–e286
  3. Mehta SR, Steg PG, Granger CB, et al. Randomized, blinded trial comparing fondaparinux with unfractionated heparin in patients undergoing contemporary percutaneous coronary intervention: Arixtra Study in Percutaneous Coronary Intervention: a Randomized Evaluation (ASPIRE) Pilot Trial. Circulation. 2005;111:1390–1397
  4. Lincoff AM, Bittl JA, Harrington RA, et al. Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial. JAMA. 2003;289:853–863
  5. Ferguson JJ, Califf RM, Antman EM, et al. Enoxaparin vs unfractionated heparin in high-risk patients with non–ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial. JAMA. 2004;292:45–54
  6. The OASIS V Investigators . Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med. 2006;354:1464–1476
  7. Kastrati A, Neumann FJ, Mehilli J, et al. Bivalirudin versus unfractionated heparin during percutaneous coronary intervention. N Engl J Med. 2008;359:688–696
  8. Hirsh J, Bauer KA, Donati MB, et al. Parenteral anticoagulants: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest. 2008;133:141S–159S
  9. Stone GW, McLaurin BT, Cox DA, et al. Bivalirudin for patients with acute coronary syndromes. N Engl J Med. 2006;355:2203–2216
  10. Stone GW, Witzenbichler B, Guagliumi G, et al. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med. 2008;358:2218–2230
  11. Braunwald E, Antman EM, Beasley JW, et al. ACC/AHA 2002 guideline update for the management of patients with unstable angina and non–ST-segment elevation myocardial infarction—summary article. J Am Coll Cardiol. 2002;40:1366–1374
  12. Fier I, Guerrero JL, Venkataraman G, et al. Efficacy of M118, a rationally engineered low-molecular-weight heparin, in a canine model of arterial thrombosis. In: Presented at ACC; 2007; New Orleans, LA. 2007;
  13. Volovyk Z, Qi Y, Becker R, et al. A rationally designed heparin, M118, has anticoagulant activity similar to unfractionated heparin and different from Lovenox in a cell-based model of thrombin generation. J Thromb Thrombolysis. 2009;28:132–139
  14. Boudriau S, Morelli G, Rivard D, et al. Safety, tolerability, pharmacokinetics and pharmacodynamics of M118, a novel, rationally engineered low-molecular-weight heparin given as a subcutaneous injection in a rising dose cohort regimen in healthy subjects. In: Presented at IXth World Conference on Clinical Pharmacology and Therapeutics; Quebec, Canada. 2008;
  15. Fier I, Morelli G, Abu-Rashid M, et al. Pharmacokinetic and pharmacodynamic properties of M118, a novel, rationally engineered low-molecular-weight heparin, following IV injection in human volunteers. In: Presented at American Society for Clinical Pharmacology and Therapeutics Annual Meeting; Orlando, FL. 2008;
  16. Fier I, Morelli G, Richey M, et al. M118, a novel, rationally engineered low-molecular-weight heparin, with potent anti-xa and anti-IIa activities is reversible by protamine sulfate, and monitorable with act following multiple IV injections. In: Presented at American Society for Clinical Pharmacology and Therapeutics Annual Meeting; Washington, DC. 2009;
  17. Abu-Rashid M, Morelli S, St-Fleur D, et al. Lack of drug-drug interactions with M118, a novel, rationally engineered low-molecular-weight heparin, when co-administered with multiple doses of aspirin and clopidogrel. In: Presented at IXth World Conference on Clinical Pharmacology and Therapeutics; Quebec, Canada. 2008;
  18. Patti G, Colonna G, Pasceri V, et al. Randomized trial of high loading dose of clopidogrel for reduction of periprocedural myocardial infarction in patients undergoing coronary intervention: results from the ARMYDA-2 (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) study. Circulation. 2005;111:2099–2106
  19. ESPRIT Investigators . Novel dosing regimen of eptifibatide in planned coronary stent implantation (ESPRIT): a randomised, placebo-controlled trial. Lancet. 2000;356:2037–2044
  20. Chew DP, Bhatt DL, Lincoff AM, et al. Defining the optimal activated clotting time during percutaneous coronary intervention: aggregate results from 6 randomized, controlled trials. Circulation. 2001;103:961–966
  21. Tolleson TR, O'Shea JC, Bittl JA, et al. Relationship between heparin anticoagulation and clinical outcomes in coronary stent intervention: observations from the ESPRIT trial. J Am Coll Cardiol. 2003;41:386–393
  22. Yusuf S, Mehta SR, Chrolavicius S, et al. Effects of fondaparinux on mortality and reinfarction in patients with acute ST-segment elevation myocardial infarction: the OASIS-6 randomized trial. JAMA. 2006;295:1519–1530
  23. Furie B, Furie BC. Molecular and cellular biology of blood coagulation. N Engl J Med. 1992;326:800–806

 Gregory W. Barsness, MD, served as guest editor for this article.

PII: S0002-8703(09)00656-5

doi: 10.1016/j.ahj.2009.08.020

American Heart Journal
Volume 158, Issue 5 , Pages 726-733 , November 2009