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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

Dan Atar, MD, FACC^_*,_*, Peter Petzelbauer, MD, PhD, Jürg Schwitter, MD, Kurt Huber, MD, FACC, Benno Rensing, MD^||, Jaroslaw D. Kasprzak, MD, PhD^¶, Christian Butter, MD^#, Lars Grip, MD, PhD^_**, Peter R. Hansen, MD, PhD, Tim Süselbeck, MD, Peter M. Clemmensen, MD, PhD, Marcos Marin-Galiano, PhD^||||, Bernard Geudelin, MD^¶¶, Peter T. Buser, MD, FACC^## for the F.I.R.E. Investigators

^_* Division of Cardiology and Faculty of Medicine, Aker University Hospital, University of Oslo, Oslo, Norway
Medical University of Vienna, Vienna, Austria
Department of Cardiology, Zurich University Hospital, Zurich, Switzerland
Department of Cardiology and Emergency Medicine, Wilhelminenhospital, Vienna, Austria
^|| Department of Cardiology, St. Antonius Ziekenhuis, Nieuwegein, the Netherlands
^¶ Szpital im. Bieganskiego, II Chair of Cardiology, Medical University of Lódz, Lódz, Poland
^# Heart Center Brandenburg in Bernau-Cardiology, Brandenburg, Germany
^_** Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden
Copenhagen University Hospital Gentofte, Hellerup, Denmark
Universitätsklinikum Mannheim I. Medizinische Klinik/Kardiologie, Mannheim, Germany
Rigshospitalet, Copenhagen University Hospital, Blegdamsvej, Copenhagen, Denmark
^|||| IFE Europe GmbH, Essen, Germany
^¶¶ Fibrex Medical Research and Development GmbH, Vienna, Austria
^## University Hospital Basel, Department of Cardiology, Basel, Switzerland

View larger version (25K): [in this window] [in a new window] [Download PPT slide]   Figure 1 Study Design CMR = cardiac magnetic resonance imaging; ECG = electrocardiogram; LGE = late gadolinium enhanced; PCI = percutaneous coronary intervention; TIMI = Thrombolysis In Myocardial Infarction.

View larger version (66K): [in this window] [in a new window] [Download PPT slide]   Figure 2 3 Different Zones on LGE CMR Images of Infarcts Three different zones—microvascular obstruction (MVO) zone (red arrows), necrotic core zone (green arrows), and total LGE zone (purple arrows)—on LGE CMR images of infarcts are shown. Image is from 5 days after myocardial infarction. This image is for representational purposes only, as not all patient images look the same. LV = left ventricle; other abbreviations as in Figure 1.

View larger version (16K): [in this window] [in a new window] [Download PPT slide]   Figure 3 Trial Profile *Number of patients for whom infarct sizes as measured by cardiac magnetic resonance imaging (CMR) are available; the number of patients for whom other results are available may differ. ECG = electrocardiogram; MI = myocardial infarction.

View larger version (21K): [in this window] [in a new window] [Download PPT slide]   Figure 4 Reduction of Mass of Infarct Size, Necrotic Core, and Total LGE Zones The mass of affected tissue and median values with 25th and 75th percentile range, 5 days after myocardial infarction, is shown. *Wilcoxon rank sum test. LGE = late gadolinium enhanced.

View larger version (21K): [in this window] [in a new window] [Download PPT slide]   Figure 5 Reduction of Necrotic Core and Total LGE Zone Size as % of LV Percent of left ventricle (LV) and median values with 25th and 75th percentile ranges 5 days after myocardial infarction is shown. *Wilcoxon rank sum test. LGE = late gadolinium enhanced.