Design and rationale of the Reduction of Infarct Expansion and Ventricular Remodeling with Erythropoietin after Large Myocardial Infarction (REVEAL) trial

American Heart Journal

Volumn 160, Issue 5, 2010, Pages

  Melloni, Chiara ^a,b   Rao, Sunil V ^a,b,c   Povsic, Thomas J ^a,b   Melton, Laura ^b   Kim, Raymond J ^a,b   Kilaru, Rakhi ^b   Patel, Manesh R ^a,b   Talan, Mark ^d   Ferrucci, Luigi ^d   Longo, Dan L ^d   Lakatta, Edward G ^d   Najjar, Samer S ^d,e   Harrington, Robert A ^a,b  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

^c DURHAM VA MEDICAL CENTER   (United States)

^d NATIONAL INSTITUTE ON AGING   (United States)

^e MEDSTAR HEALTH RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; RECOMBINANT ERYTHROPOIETIN;

ACUTE HEART INFARCTION; ARTICLE; CELL COUNT; CINEANGIOCARDIOGRAPHY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG EFFECT; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; ENDOTHELIUM CELL; FEMALE; HEART INFARCTION SIZE; HEART LEFT VENTRICLE EJECTION FRACTION; HEART LEFT VENTRICLE MASS; HEART LEFT VENTRICLE SIZE; HEART LEFT VENTRICLE VOLUME; HEART MUSCLE REPERFUSION; HEART VENTRICLE REMODELING; HUMAN; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NUCLEAR MAGNETIC RESONANCE IMAGING; PERCUTANEOUS CORONARY INTERVENTION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; STEM CELL; STROKE; TRANSIENT ISCHEMIC ATTACK; TREATMENT OUTCOME;

EID: 78649377581     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2010.09.007     Document Type: Article

References (59)

1. Antman E.M., Hand M., and Armstrong P.W. 2007 Focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines J Am Coll Cardiol 51 2008 210 247
2. Fox K.A., Steg P.G., and Eagle K.A. Decline in rates of death and heart failure in acute coronary syndromes, 1999-2006 JAMA 297 2007 1892 1900
3. Pfeffer M., and Braunwald E. Ventricular remodeling after myocardial infarction. Experimental observations and clinical implications Circulation 81 1990 1161 1172
4. Biagini E., van Geuns R.J., and Baks T. Comparison between contrast echocardiography and magnetic resonance imaging to predict improvement of myocardial function after primary coronary intervention Am J Cardiol 97 2006 361 366
5. Verma A., Meris A., and Skali H. Prognostic implications of left ventricular mass and geometry following myocardial infarction: the VALIANT (VALsartan In Acute myocardial iNfarcTion) Echocardiographic Study JACC Cardiovasc Imaging 1 2008 582 591
6. The APEX Investigators Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention A randomized controlled trial. JAMA 297 2007 43 51
7. Baran K.W., Nguyen M., and McKendall G.R. Double-blind, randomized trial of an anti-CD18 antibody in conjunction with recombinant tissue plasminogen activator for acute myocardial infarction: limitation of myocardial infarction following thrombolysis in acute myocardial infarction (LIMIT AMI) study Circulation 104 2001 2778 2783
8. Faxon D.P., Gibbons R.J., and Chronos N.A. The effect of blockade of the CD11/CD18 integrin receptor on infarct size in patients with acute myocardial infarction treated with direct angioplasty: the results of the HALT-MI study J Am Coll Cardiol 40 2002 1199 1204
9. Wright G.L., Hanlon P., and Amin K. Erythropoietin receptor expression in adult rat cardiomyocytes is associated with an acute cardioprotective effect for recombinant erythropoietin during ischemia-reperfusion injury FASEB 18 2004 1031 1033
10. Cai Z., Manalo D.J., and Wei G. Hearts from rodents exposed to intermittent hypoxia or erythropoietin are protected against ischemia-reperfusion injury Circulation 108 2003 79 85
11. Parsa C.J., Matsumoto A., and Kim J. A novel protective effect of erythropoietin in the infarcted heart J Clin Invest 112 2003 999 1007
12. Moon C., Krawczyk M., and Ahn D. Erythropoietin reduces myocardial infarction and left ventricular functional decline after coronary artery ligation in rats Proc Natl Acad Sci U S A 100 2003 11612 11617
13. Lipšic E., Schoemaker R.G., and van der Meer P. Protective effects of erythropoietin in cardiac ischemia: from bench to bedside J Am Coll Cardiol 48 2006 2161 2167
14. van der Meer P., Lipšic E., and Henning R.H. Erythropoietin induces neovascularization and improves cardiac function in rats with heart failure after myocardial infarction J Am Coll Cardiol 46 2005 125 133
15. Lipšic E., Westenbrink B.D., and van der Meer P. Low-dose erythropoietin improves cardiac function in experimental heart failure without increasing haematocrit Eur J Heart Fail 10 2008 22 29
16. Hirata A., Minamino T., and Asanuma H. Erythropoietin enhances neovascularization of ischemic myocardium and improves left ventricular dysfunction after myocardial infarction in dogs J Am Coll Cardiol 48 2006 176 184
17. Mancini D.M., Katz S.D., and Lang C.C. Effect of erythropoietin on exercise capacity in patients with moderate to severe chronic heart failure Circulation 107 2003 294 299
18. Ehrenreich H., Hasselblatt M., and Dembowski C. Erythropoietin therapy for acute stroke is both safe and beneficial Mol Med 8 2002 495 505
19. Liem A., van de Woestijne A.P., and Bruijns E. Effect of EPO administration on myocardial infarct size in patients with non-STE acute coronary syndromes; results from a pilot study Int J Cardiol 131 2009 285 287
20. Ehrenreich H., Weissenborn K., and Prange H. Recombinant human erythropoietin in the treatment of acute ischemic stroke Stroke 40 2009 e647 56
21. Ghali J.K., Anand I.S., and Abraham W.T. Randomized double-blind trial of darbepoetin alfa in patients with symptomatic heart failure and anemia Circulation 117 2008 526 535
22. Ott I., Schulz S., and Mehilli J. Erythropoietin in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a randomized, double-blind trial Circ Cardiovasc Interv 2010 [Epub ahead of print]. DOI: 10.1161/CIRCINTERVENTIONS.109.904425
23. Kim R.J., Albert T.S., and Wible J.H. Performance of delayed-enhancement MRI using gadoversetamide contrast for the detection and assessment of myocardial infarction: an international, multicenter, double-blinded, randomized trial Circulation 117 2008 629 637
24. Patel M.R., Worthley S.G., and Stebbins A. Pexelizumab and infarct size in patients with acute myocardial infarction undergoing primary PCI: a delayed enhancement cardiac magnetic resonance substudy from the APEX-AMI trial JACC Cardiovasc Imaging 3 2010 52 60
25. Povsic T.J., Zavodni K.L., and Vainorius E. Common endothelial progenitor cell assays identify discrete endothelial progenitor cell populations Am Heart J 157 2009 335 344
26. Povsic T.J., Adams S.D., and Zavodni K.L. Aldehyde dehydrogenase activity allows reliable EPC enumeration in stored peripheral blood samples J Thromb Thrombolysis 28 2009 259 265
27. Cutlip D.E., Windecker S., and Mehran R. Clinical end points in coronary stent trials: a case for standardized definitions Circulation 115 2007 2344 2351
28. Marzo F., Lavorgna A., and Coluzzi G. Erythropoietin in heart and vessels: focus on transcription and signalling pathways J Thromb Thrombolysis 26 2008 183 187
29. Anagnostou A., Liu Z., and Steiner M. Erythropoietin receptor mRNA expression in human endothelial cells Proc Natl Acad Sci U S A 91 1994 3974 3978 (Pubitemid 24139555)
30. Heeschen C., Aicher A., and Lehmann R. Erythropoietin is a potent physiologic stimulus for endothelial progenitor cell mobilization Blood 102 2003 1340 1346
31. Bahlmann F.H., De Groot K., and Spandau J.M. Erythropoietin regulates endothelial progenitor cells Blood 103 2004 921 926
32. Takahashi T., Kalka C., and Masuda H. Ischemia- and cytokine-induced mobilization of bone marrow-derived endothelial progenitor cells for neovascularization Nat Med 5 1999 434 438 (Pubitemid 29180584)
33. Urao N., Okigaki M., and Yamada H. Erythropoietin-mobilized endothelial progenitors enhance reendothelialization via Akt-endothelial nitric oxide synthase activation and prevent neointimal hyperplasia Circ Res 98 2006 1405 1413
34. Anagnostou A., Lee E.S., and Kessimian N. Erythropoietin has a mitogenic and positive chemotactic effect on endothelial cells Proc Natl Acad Sci U S A 87 1990 5978 5982
35. Shingo T., Sorokan S.T., and Shimazaki T. Erythropoietin regulates the in vitro and in vivo production of neuronal progenitors by mammalian forebrain neural stem cells J Neurosci 21 2001 9733 9743
36. Andreotti F., Agati L., and Conti E. Update on phase II studies of erythropoietin in acute myocardial infarction. Rationale and design of Exogenous erythroPoietin in Acute Myocardial Infarction: New Outlook aNd Dose Association Study (EPAMINONDAS) J Thromb Thrombolysis 28 2009 48995 (EudraCTno. 200500485386)
37. van der Meer P., Lipšic E., and van Gilst W.H. Erythropoietin: from hematopoiesis to cardioprotection Cardiovasc Drugs Ther 19 2005 7 8
38. Bogoyevitch M.A. An update on the cardiac effects of erythropoietin cardioprotection by erythropoietin and the lessons learnt from studies in neuroprotection Cardiovasc Res 63 2004 208 216
39. Brines M., Grasso G., and Fiordaliso F. Erythropoietin mediates tissue protection through an erythropoietin and common beta-subunit heteroreceptor Proc Natl Acad Sci U S A 101 2004 14907 14912
40. Tramontano A.F., Muniyappa R., and Black A.D. Erythropoietin protects cardiac myocytes from hypoxia-induced apoptosis through an Akt-dependent pathway Biochem Biophys Res Commun 308 2003 990 994
41. Kocher A.A., Schuster M.D., and Szabolcs M.J. Neovascularization of ischemic myocardium by human bone-marrow-derived angioblasts prevents cardiomyocyte apoptosis, reduces remodeling and improves cardiac function Nat Med 7 2001 430 436
42. Calvillo L., Latini R., and Kajstura J. Recombinant human erythropoietin protects the myocardium from ischemia-reperfusion injury and promotes beneficial remodeling Proc Natl Acad Sci U S A 100 2003 4802 4806
43. Lipšic E., van der Meer P., and Henning R.H. Timing of erythropoietin treatment for cardioprotection in ischemia/reperfusion J Cardiovasc Pharmacol 44 2004 473 479
44. Moon C., Krawczyk M., and Paik D. Cardioprotection by recombinant human erythropoietin following acute experimental myocardial infarction: dose response and therapeutic window Cardiovasc Drugs Ther 19 2005 243 250
45. Silverberg D.S., Wexler D., and Sheps D. The effect of correction of mild anemia in severe, resistant congestive heart failure using subcutaneous erythropoietin and intravenous iron: a randomized controlled study J Am Coll Cardiol 37 2001 1775 1780
46. Palazzuoli A., Silverberg D., and Iovine F. Erythropoietin improves anemia exercise tolerance and renal function and reduces B-type natriuretic peptide and hospitalization in patients with heart failure and anemia Am Heart J 152 2006 1096.e9 1096.e15
47. Lipsic E., van der Meer P., and Voors A.A. A single bolus of a long-acting erythropoietin analogue darbepoetin alfa in patients with acute myocardial infarction: a randomized feasibility and safety study Cardiovasc Drugs Ther 20 2006 135 141
48. Ferrario M., Arbustini E., and Massa M. High-dose erythropoietin in patients with acute myocardial infarction: A pilot, randomised, placebo-controlled study Int J Cardiol 2009 [Epub ahead of print]
49. Binbrek A.S., Rao N.S., and Al Khaja N. Erythropoietin to augment myocardial salvage induced by coronary thrombolysis in patients with ST segment elevation acute myocardial infarction Am J Cardiol 104 2009 1035 1040
50. Mehta J.L. Erythropoietin in cardioprotection: does it have a future or is it all in the past? Cardiovasc Res 79 2008 549 550
51. Voors A.A., Belonje A.M., and Zijlstra F. A single dose of erythropoietin in ST-elevation myocardial infarction Eur Heart J 2010 Epub ahead of print]. DOI: 10.1093/eurheartj/ehq304
52. Mitka M. New limits advised for anemia drugs JAMA 299 2008 2016
53. Kim R.J., Shah D.J., and Judd R.M. How we perform delayed enhancement imaging J Cardiovasc Magn Reson 5 2003 505 514
54. Sievers B., Elliott M.D., and Hurwitz L.M. Rapid detection of myocardial infarction by sub-second, free-breathing delayed contrast-enhancement cardiovascular magnetic resonance Circulation 115 2007 236 244
55. Weinsaft J.W., Kim H.W., and Shah D. Detection of left ventricular thrombus by delayed-enhancement CMR: Prevalence and markers in patients with systolic dysfunction J Am Coll Cardiol 52 2008 148 157
56. Pennell D.J., Sechtem U.P., and Higgins C.B. Clinical indications for cardiovascular magnetic resonance (CMR): Consensus Panel report Eur Heart J 25 2004 1940 1965
57. Kim H.W., Farzaneh-Far A., and Klem I. Magnetic resonance imaging of the heart V. Fuster, R.A. O'Rourke, P. Poole-Wilson, Hurst's The Heart 13th ed. 2010 McGraw Hill New York (N.Y.)
58. Kim R.J., Fieno D.S., and Parrish T.B. Relationship of MRI delayed contrast enhancement to irreversible injury, infarct age, and contractile function Circulation 100 1999 1992 2002
59. Kim H.W., Farzaneh-Far A., and Kim R.J. Cardiovascular magnetic resonance in patients with myocardial infarction - current and emerging applications J Am Coll Cardiol 55 2010 1 16