American Heart Journal
Volume 155, Issue 1 , Pages 113.e1-113.e8 , January 2008

A randomized, double-blind, placebo-controlled study of the safety and efficacy of intravenous MCC-135 as an adjunct to primary percutaneous coronary intervention in patients with acute myocardial infarction: Evaluation of MCC-135 for left ventricular salvage in acute myocardial infarction (EVOLVE)

  • Ik-Kyung Jang, MD, PhD

      Affiliations

    • Massachusetts General Hospital and Harvard Medical School, Boston, MA
    • Corresponding Author InformationReprint requests: Ik-Kyung Jang, MD, PhD, Cardiology Division, Gray/Bigelow 800, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114.
    • ,
  • Neil J. Weissman, MD

      Affiliations

    • Washington Hospital Center, Washington DC
    • ,
  • Michael H. Picard, MD

      Affiliations

    • Massachusetts General Hospital and Harvard Medical School, Boston, MA
    • ,
  • Michael R. Zile, MD

      Affiliations

    • RHJ Department of Veterans Affairs Medical Center, and the Medical University of South Carolina, Charleston, SC
    • ,
  • Veronica Pettigrew, RN, BSN

      Affiliations

    • Mitsubishi Pharma America, Inc., Warren, NJ
    • ,
  • Steven Shen, PhD

      Affiliations

    • Mitsubishi Pharma America, Inc., Warren, NJ
    • ,
  • Jun Tatsuno, MSc

      Affiliations

    • Mitsubishi Pharma Corporation, Osaka, Japan
    • ,
  • Mark G. Hibberd, MD, PhD

      Affiliations

    • CardioCorp Cardiovascular Clinical Research, Lexington, MA
    • ,
  • Dan Tzivoni, MD

      Affiliations

    • Shaare Zedek Medical Centre, Jerusalem, Israel
    • ,
  • Frans J. Th. Wackers, MD

      Affiliations

    • Yale University Radionuclide CORE Laboratory, Yale University, New Haven, CT
    • ,
  • the EVOLVE Investigators

Received 11 April 2007 ,Accepted 20 August 2007.

References 

  1. Montalescot G, Barragan P, Wittenberg O, et al. for the ADMIRAL Investigators Platelet glycoprotein IIb/IIIa inhibition with coronary stenting for acute myocardial infarction. N Engl J Med. 2001;344:1895–1903
  2. Stone GW, Grines CL, Cox DA, et al. Controlled abciximab and device investigation to lower late angioplasty complications (CADILLAC) investigators. Comparison of angioplasty with stenting with or without abciximab in acute myocardial infarction. N Engl J Med. 2002;346:957–966
  3. Shihara M, Tsutsui H, Tsuchihashi M, et al. for the Japanese Coronary Invention Study (JCIS) Group In-hospital and one-year outcomes for patients undergoing percutaneous coronary intervention for acute myocardial infarction. Am J Cardiol. 2002;90:932–936
  4. Williams DO, Holubkov R, Yeh W, et al. Percutaneous coronary intervention in the current era compared with 1985-1986: the National Heart, Lung, and Blood Institute Registries. Circulation. 2000;102:2945–2951
  5. The EPISTENT Investigators . Randomised placebo-controlled and balloon-angioplasty–controlled trial to assess safety of coronary stenting with use of platelet glycoprotein-IIb/IIIa blockade. Lancet. 1998;352:87–92
  6. Topol EJ, Mark DB, Lincoff AM, et al. for the EPISTENT Investigators Outcomes at 1 year and economic implications of platelet glycoprotein IIb/IIIa blockade in patients undergoing coronary stenting: results from a multicentre randomised trial. Lancet. 1999;354:2019–2024
  7. Mehta SR, Yusuf S, Diaz R, et al. Effect of glucose-insulin-potassium infusion on mortality in patients with acute ST elevation myocardial infarction: the CREATE-ECLA randomized controlled trial. JAMA. 2005;293:437–446
  8. Stone GW, Webb J, Cox DA, et al. for EMERALD Investigators Distal microcirculatory protection during percutaneous coronary intervention in acute ST-segment elevation myocardial infarction: A randomized controlled trial. JAMA. 2005;293:1063–1072
  9. Granger CB, Mahaffey KW, Weaver WD, et al. for the COMMA investigators Pexelizumab, an anti-C5 complement antibody, as adjunctive therapy to primary percutaneous coronary intervention in acute myocardial infarction: the COMplement inhibition in Myocardial infarction treated with Angioplasty (COMMA) trial. Circulation. 2003;108:1184–1190
  10. Mahaffey KW, Granger CB, Nicolau JC, et al. for the COMPLY Investigators Effect of pexelizumab, an anti-C5 complement antibody, as adjunctive therapy to fibrinolysis in acute myocardial infarction: the COMPlement inhibition in myocardial infarction treated with thromboLYtics (COMPLY) trial. Circulation. 2003;108:1176–1183
  11. Mahaffey KW, Puma JA, Barbagelata NA, et al. for the AMISTAD Investigators Adenosine as an adjunct to thrombolytic therapy for acute myocardial infarction: results of a multicenter, randomized, placebo-controlled trial: the Acute Myocardial Infarction STudy of ADenosine (AMISTAD) trial. J Am Coll Cardiol. 1999;34:1711–1720
  12. Ross AM, Gibbons RJ, Stone GW, et al. A randomized, double-blinded, placebo-controlled multicenter trial of adenosine as an adjunct to reperfusion in the treatment of acute myocardial infarction (AMISTAD-II). J Am Coll Cardiol. 2005;45:1775–1780
  13. Theroux P, Chaitman BR, Danchin N, et al. for the GUARd During Ischemia Against Necrosis (GUARDIAN) Investigators Inhibition of the sodium-hydrogen exchanger with cariporide to prevent myocardial infarction in high-risk ischemic situations: Main results of the GUARDIAN trial. Circulation. 2000;102:3032–3038
  14. Zeymer U, Suryapranata H, Monassier JP, et al. for the ESCAMI Investigators The Na+/H+ exchange inhibitor eniporide as an adjunct to early reperfusion therapy for acute myocardial infarction: Results of the evaluation of the safety and cardioprotective effects of eniporide in acute myocardial infarction (ESCAMI) trial. J Am Coll Cardiol. 2001;38:1644–1650
  15. Dixon SR, Rizik DG, Griffin JJ, et al. for the COOL-MI Investigators In: A Prospective, Randomized Trial of Mild Hypothermia During Primary Percutaneous Intervention for Acute Myocardial Infarction (COOL-MI): one-Year Clinical Outcome Paper presented at the American College of Cardiology 53rd Annual Meeting; March 7-10; New Orleans, Louisiana. 2004;
  16. O'Neill WW, Martin JL, Dixon SR, et al. for the AMIHOT Investigators Acute Myocardial Infarction With Hyperoxemic Therapy (AMIHOT): a prospective, randomized, multicenter trial. In: Paper presented at the American College of Cardiology 53rd Annual Meeting; March 7-10; New Orleans, Louisiana. 2004;
  17. Verma S, Fedak PW, Weisel RD, et al. Fundamentals of reperfusion injury for the clinical cardiologist. Circulation. 2002;105:2332–2336
  18. Shigekawa M, Iwamoto T. Cardiac Na(+)-Ca(2+) exchange: molecular and pharmacological aspects. Circ Res. 2001;88:864–876
  19. Satoh N, Kitada Y. Cardioprotective effect of MCC-135 is associated with inhibition of Ca2+ overload in ischemic/reperfused hearts. Eur J Pharmacol. 2004;499:179–187
  20. Satoh N, Sato T, Shimada M, et al. Lusitropic effect of MCC-135 is associated with improvement of sarcoplasmic reticulum function in ventricular muscles of rats with diabetic cardiomyopathy. J Pharmacol Exp Ther. 2001;298:1161–1166
  21. Kawasumi H, Satoh N, Abe Y, et al. MCC-135, a new agent for the treatment of heart diseases. Jpn J Pharmacol. 1998;76(suppl I):277P
  22. Yarbrough WM, Mukherjee R, Escobar GP, et al. Modulation of calcium transport improves myocardial contractility and enzyme profiles after prolonged ischemia-reperfusion. Ann Thorac Surg. 2003;76:2054–2061
  23. Jang IK, Pettigrew V, Picard MH, et al. A randomized, double-blind, placebo-controlled study of the safety and efficacy of intravenous MCC-135 as an adjunct to primary percutaneous coronary intervention in patients with acute myocardial infarction: rationale and design of the Evaluation of MCC-135 for Left ventricular Salvage in Acute MI (EVOLVE) study. J Thromb Thrombolysis. 2005;20:147–153
  24. DePuey GE. Imaging guidelines for nuclear cardiology procedures. On line: www.asnc.org Menu: “manage your practice”: guidelines and standards; The American Society of Nuclear Cardiology. 2006;
  25. Liu YH, Sinusas AJ, DeMan P, et al. Quantification of single photon emission computerized tomographic myocardial perfusion images: methodology and validation of the Yale-CQ method. J Nucl Cardiol. 1999;6:190–203
  26. Liu YH, Sinusas AJ, Khaimov D, et al. New hybrid count and geometry-based method for quantification of left ventricular volumes and ejection fraction from ECG-gated SPECT: methodology and validation. J Nucl Cardiol. 2005;12:55–65
  27. Bär FW, Tzivoni D, Dirksen MT, et al. on behalf of the CASTEMI Study Group Results of the first clinical study of adjunctive Caldaret (MCC-135) in patients undergoing primary percutaneous coronary intervention for ST-Elevation Myocardial Infarction: the randomized multicenter CASTEMI study. Eur Heart J. 2006;27:2516–2523
  28. Elashoff JE. nQuery Advisor Version 4.0 User's Guide. Los Angeles, CA: Dixon Associates; 2000.
  29. Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI). Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction. Lancet. 1986;1:397–402

 The study was supported by a grant from Mitsubishi Pharma Corporation, Osaka, Japan.

 Conflict of interest IKJ, MHP, MGH, and FJTW: members of the EVOLVE study scientific advisory committee and received honoraria; NJW, MHP, and FJTW: directors of core laboratory and received payment for their work; VP and SS: full-time employees of Mitsubishi Pharma America Ltd, Warren, NJ; JT: a full-time employee of Mitsubishi Pharma Corporation in Japan; IKJ, MZ, and MH: consultant to Mitsubishi Pharma America Ltd, Warren, NJ.

PII: S0002-8703(07)00706-5

doi: 10.1016/j.ahj.2007.08.020

American Heart Journal
Volume 155, Issue 1 , Pages 113.e1-113.e8 , January 2008

Article Tools

* Image Usage & Resolution