Effect of Intravenous FX06 as an Adjunct to Primary Percutaneous Coronary Intervention for Acute ST-Segment Elevation Myocardial Infarction. Results of the F.I.R.E. (Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury) Trial

Journal of the American College of Cardiology

Volumn 53, Issue 8, 2009, Pages 720-729

  Atar, Dan ^a   Petzelbauer, Peter ^b   Schwitter, Jürg ^c   Huber, Kurt ^d   Rensing, Benno ^e   Kasprzak, Jaroslaw D ^f   Butter, Christian ^g   Grip, Lars ^h   Hansen, Peter R ⁱ   Süselbeck, Tim ^j   Clemmensen, Peter M ^k   Marin Galiano, Marcos ^l   Geudelin, Bernard ^m   Buser, Peter T ⁿ  

^a AKER UNIVERSITY HOSPITAL   (Norway)

^b MEDICAL UNIVERSITY OF VIENNA   (Austria)

^c UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^d Wilhelminenhospital ^*  (Austria)

^e ST ANTONIUS HOSPITAL   (Netherlands)

^f MEDICAL UNIVERSITY OF LODZ   (Poland)

^g Heart Center Brandenburg in Bernau Cardiology   (Germany)

^h SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

ⁱ GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

^j UNIVERSITY OF HEIDELBERG   (Germany)

^k Rigshospitalet   (Denmark)

^l IFE Europe GmbH   (Germany)

^m Fibrex Medical Research and Development GmbH   (Austria)

ⁿ UNIVERSITY HOSPITAL BASEL   (Switzerland)

more..

Author keywords

acute myocardial infarction; cardiac magnetic resonance imaging; FX06; percutaneous coronary intervention; reperfusion injury; ST segment elevation

Indexed keywords

FIBRIN DERIVATIVE; FX 06; GADOLINIUM; TROPONIN I; UNCLASSIFIED DRUG;

ACUTE CORONARY SYNDROME; ACUTE HEART INFARCTION; ADULT; AGED; ARTICLE; CARDIOGENIC SHOCK; CLINICAL TRIAL; CONTRAST ENHANCEMENT; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOLLOW UP; HEART DEATH; HEART FAILURE; HEART INFARCTION SIZE; HEART VENTRICLE FIBRILLATION; HEART VENTRICLE TACHYCARDIA; HUMAN; LUNG EDEMA; MAGNETIC RESONANCE ANGIOGRAPHY; MAJOR CLINICAL STUDY; MALE; ORTHOSTATIC HYPOTENSION; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REPERFUSION INJURY; REVASCULARIZATION; SIDE EFFECT; SINGLE DRUG DOSE; ST SEGMENT ELEVATION; STENT THROMBOSIS;

ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; COMBINED MODALITY THERAPY; DOUBLE-BLIND METHOD; ELECTROCARDIOGRAPHY; FEMALE; FIBRIN FIBRINOGEN DEGRADATION PRODUCTS; HUMANS; INJECTIONS, INTRAVENOUS; MAGNETIC RESONANCE IMAGING; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; MYOCARDIAL REPERFUSION INJURY; MYOCARDIUM; NECROSIS; PEPTIDE FRAGMENTS; THROMBOLYTIC THERAPY;

EID: 60049083078     PISSN: 07351097     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jacc.2008.12.017     Document Type: Article

References (45)

1. Silber S., Albertsson P., Aviles F.F., et al. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J 26 (2005) 804-847
2. Yellon D.M., and Hausenloy D.J. Myocardial reperfusion injury. N Engl J Med 357 (2007) 1121-1135
3. Bolli R., and Marban E. Molecular and cellular mechanisms of myocardial stunning. Physiol Rev 79 (1999) 609-634
4. Halestrap A.P., Clarke S.J., and Javadov S.A. Mitochondrial permeability transition pore opening during myocardial reperfusion-a target for cardioprotection. Cardiovasc Res 61 (2004) 372-385
5. Dirksen M.T., Laarman G.J., Simoons M.L., and Duncker D.J. Reperfusion injury in humans: a review of clinical trials on reperfusion injury inhibitory strategies. Cardiovasc Res 74 (2007) 343-355
6. Armstrong P.W., Granger C.B., Adams P.X., et al. Pexelizumab for acute ST-elevation myocardial infarction in patients undergoing primary percutaneous coronary intervention: a randomized controlled trial. JAMA 297 (2007) 43-51
7. Bates E., Bode C., Costa M., et al. Intracoronary KAI-9803 as an adjunct to primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction. Circulation 117 (2008) 886-896
8. Mahaffey K.W., Puma J.A., Barbagelata N.A., et al. 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 34 (1999) 1711-1720
9. Kitakaze M., Asakura M., Kim J., et al. Human atrial natriuretic peptide and nicorandil as adjuncts to reperfusion treatment for acute myocardial infarction (J-WIND): two randomised trials. Lancet 370 (2007) 1483-1493
10. Thibault H., Piot C., Staat P., et al. Long-term benefit of postconditioning. Circulation 117 (2008) 1037-1044
11. Piot C., Croisille P., Staat P., et al. Effect of cyclosporine on reperfusion injury in acute myocardial infarction. N Engl J Med 359 (2008) 473-481
12. Kudryk B., Robinson D., Netre C., et al. Measurement in human blood of fibrinogen/fibrin fragments containing the B beta 15-42 sequence. Thromb Res 25 (1982) 277-291
13. Fareed J., Hoppensteadt D.A., Leya F., et al. Useful laboratory tests for studying thrombogenesis in acute cardiac syndromes. Clin Chem 44 (1998) 1845-1853
14. Petzelbauer P., Zacharowski P.A., Miyazaki Y., et al. The fibrin-derived peptide Bbeta15-42 protects the myocardium against ischemia-reperfusion injury. Nat Med 11 (2005) 298-304
15. Roesner J.P., Petzelbauer P., Koch A., et al. The fibrin-derived peptide Bbeta15-42 is cardioprotective in a pig model of myocardial ischemia-reperfusion injury. Crit Care Med 35 (2007) 1730-1735
16. Zacharowski K., Zacharowski P.A., Friedl P., et al. The effects of the fibrin-derived peptide Bbeta(15-42) in acute and chronic rodent models of myocardial ischemia-reperfusion. Shock 27 (2007) 631-637
17. Roesner J., Petzelbauer P., Koch A., et al. Bbeta15-42 (FX06) reduces pulmonary, myocardial, liver and small intestine damage in a pig model of hemorrhagic shock and reperfusion. Crit Care Med 37 (2009) 598-605
18. Atar D., Huber K., Rupprecht H.J., et al. Rationale and design of the 'F.I.R.E.' study. A multicenter, double-blind, randomized, placebo-controlled study to measure the effect of FX06 (a fibrin-derived peptide Bbeta(15-42)) on ischemia-reperfusion injury in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention. Cardiology 108 (2007) 117-123
19. Knuesel P.R., Nanz D., Wyss C., et al. Characterization of dysfunctional myocardium by positron emission tomography and magnetic resonance: relation to functional outcome after revascularization. Circulation 108 (2003) 1095-1100
20. Ryf S., Rutz A.K., Boesiger P., and Schwitter J. Is post-systolic shortening a reliable indicator of myocardial viability?. An MR tagging and late-enhancement study. J Cardiovasc Magn Reson 8 (2006) 445-451
21. Kim R.J., Wu E., Rafael A., et al. The use of contrast-enhanced magnetic resonance imaging to identify reversible myocardial dysfunction. N Engl J Med 343 (2000) 1445-1453
22. Bartko J.J. The intraclass correlation coefficient as a measure of reliability. Psychol Rep 19 (1966) 3-11
23. Hudsmith L.E., Petersen S.E., Francis J.M., Robson M.D., and Neubauer S. Normal human left and right ventricular and left atrial dimensions using steady state free precession magnetic resonance imaging. J Cardiovasc Magn Reson 7 (2005) 775-782
24. Rehwald W.G., Fieno D.S., Chen E.L., Kim R.J., and Judd R.M. Myocardial magnetic resonance imaging contrast agent concentrations after reversible and irreversible ischemic injury. Circulation 105 (2002) 224-229
25. Schwitter J., Saeed M., Wendland M.F., et al. Influence of severity of myocardial injury on distribution of macromolecules: extravascular versus intravascular gadolinium-based magnetic resonance contrast agents. J Am Coll Cardiol 30 (1997) 1086-1094
26. Wu K.C., Kim R.J., Bluemke D.A., et al. Quantification and time course of microvascular obstruction by contrast-enhanced echocardiography and magnetic resonance imaging following acute myocardial infarction and reperfusion. J Am Coll Cardiol 32 (1998) 1756-1764
27. Wu K.C., Zerhouni E.A., Judd R.M., et al. Prognostic significance of microvascular obstruction by magnetic resonance imaging in patients with acute myocardial infarction. Circulation 97 (1998) 765-772
28. Arheden H., Saeed M., Higgins C.B., et al. Measurement of the distribution volume of gadopentetate dimeglumine at echo-planar MR imaging to quantify myocardial infarction: comparison with 99mTc-DTPA autoradiography in rats. Radiology 211 (1999) 698-708
29. Vestweber D. VE-cadherin: the major endothelial adhesion molecule controlling cellular junctions and blood vessel formation. Arterioscler Thromb Vasc Biol 28 (2008) 223-232
30. Dejana E., Orsenigo F., and Lampugnani M.G. The role of adherens junctions and VE-cadherin in the control of vascular permeability. J Cell Sci 121 (2008) 2115-2122
31. Ryden L., Sjoquist P.-O., and Wang Q.-D. Pharmacological tools for the limitation of myocardial reperfusion injury. Experimental evidence. Eur Heart J Suppl 3 Suppl C (2001) C28-C35
32. Gibbons R.J., Miller T.D., and Christian T.F. Infarct size measured by single photon emission computed tomographic imaging with (99m)Tc-sestamibi: a measure of the efficacy of therapy in acute myocardial infarction. Circulation 101 (2000) 101-108
33. Miller T.D., Christian T.F., Hopfenspirger M.R., et al. Infarct size after acute myocardial infarction measured by quantitative tomographic 99mTc sestamibi imaging predicts subsequent mortality. Circulation 92 (1995) 334-341
34. Carlsson M., Arheden H., Higgins C.B., and Saeed M. Magnetic resonance imaging as a potential gold standard for infarct quantification. J Electrocardiol 41 (2008) 614-620
35. Wagner A., Mahrholdt H., Holly T.A., et al. Contrast-enhanced MRI and routine single photon emission computed tomography (SPECT) perfusion imaging for detection of subendocardial myocardial infarcts: an imaging study. Lancet 361 (2003) 374-379
36. Klem I., Shah D., White R., et al. Prognostic value of cardiovascular magnetic resonance assessment of left ventricular function and scar-a multicenter study. (abstr). Eur Heart J 27 Suppl (2006) 28
37. Wu E., Ortiz J.T., Tejedor P., et al. Infarct size by contrast enhanced cardiac magnetic resonance is a stronger predictor of outcomes than left ventricular ejection fraction or end-systolic volume index: prospective cohort study. Heart 94 (2008) 730-736
38. Janssens S., Dubois C., Bogaert J., et al. Autologous bone marrow-derived stem-cell transfer in patients with ST-segment elevation myocardial infarction: double-blind, randomised controlled trial. Lancet 367 (2006) 113-121
39. Yan A.T., Shayne A.J., Brown K.A., et al. Characterization of the peri-infarct zone by contrast-enhanced cardiac magnetic resonance imaging is a powerful predictor of post-myocardial infarction mortality. Circulation 114 (2006) 32-39
40. Thiele H., Kappl M.J., Linke A., et al. Influence of time-to-treatment, TIMI-flow grades, and ST-segment resolution on infarct size and infarct transmurality as assessed by delayed enhancement magnetic resonance imaging. Eur Heart J 28 (2007) 1433-1439
41. Luo A.K., and Wu K.C. Imaging microvascular obstruction and its clinical significance following acute myocardial infarction. Heart Fail Rev 11 (2006) 305-312
42. Nijveldt R., Beek A.M., Hirsch A., et al. Functional recovery after acute myocardial infarction: comparison between angiography, electrocardiography, and cardiovascular magnetic resonance measures of microvascular injury. J Am Coll Cardiol 52 (2008) 181-189
43. Beek A.M., Kuhl H.P., Bondarenko O., et al. Delayed contrast-enhanced magnetic resonance imaging for the prediction of regional functional improvement after acute myocardial infarction. J Am Coll Cardiol 42 (2003) 895-901
44. Kwong R.Y., Chan A.K., Brown K.A., et al. Impact of unrecognized myocardial scar detected by cardiac magnetic resonance imaging on event-free survival in patients presenting with signs or symptoms of coronary artery disease. Circulation 113 (2006) 2733-2743
45. Mahrholdt H., Wagner A., Holly T.A., et al. Reproducibility of chronic infarct size measurement by contrast-enhanced magnetic resonance imaging. Circulation 106 (2002) 2322-2327