Impact of time to therapy and presence of collaterals on the efficacy of FX06 in acute ST elevation myocardial infarction: a substudy of the F.I.R.E., the Efficacy of FX06 in the prevention of myocardial reperfusion injury trial.
To determine whether the efficacy of FX06 was dependent upon the timing of reperfusion therapy or the presence of collaterals in the Efficacy of FX06 in the prevention of myocardial reperfusion injury (F.I.R.E.) trial.



Two hundred and thirty-four (234) patients presenting with acute ST-segment elevation myocardial infarction were randomised to FX06 or matching placebo given as an intravenous bolus at reperfusion. Infarct size was assessed at 5-7 days and four months after myocardial infarction by cardiac magnetic resonance imaging determined total late enhancement and necrotic core zone. Patients were stratified according to presentation status (time-to-therapy <3 hours, n=108; time-to-therapy=3-6 hours, n=115) and presence of collaterals (yes, 46; no, 177). There were no statistically significant differences between groups at day 5-7. At four months, we observed statistically significant reductions of both measures of infarct size (0.3% vs. 2.4%, p=0.038; 8.0% vs. 16.0%, p=0.032) in the group given FX06 and presenting early. There was also a statistically significant reduction of total late enhancement zone among patients given FX06 with collaterals (7.3% vs. 15.2%, p=0.043). No differences were evident among late presenters or those without collaterals.



FX06 significantly reduced infarct size at four months in the early presenters and in those with collaterals.
Hallén
Jonas
J
Department of Cardiology, Oslo University Hospital, Aker and University of Oslo, Norway. jonahall@medisin.uio.no <jonahall@medisin.uio.no>
Petzelbauer
Peter
P
Schwitter
Jürg
J
Geudelin
Bernard
B
Buser
Peter
P
Atar
Dan
D
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D015415:Biomarkers / Q000097:blood; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003097:Collateral Circulation; D003326:Coronary Circulation; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000008:administration & dosage*; D006801:Humans; D007275:Injections, Intravenous; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D015428:Myocardial Reperfusion Injury / Q000209:etiology / Q000473:pathology / Q000503:physiopathology / Q000517:prevention & control*; D009206:Myocardium / Q000473:pathology; D010446:Peptide Fragments / Q000008:administration & dosage*; D013318:Stroke Volume; D013997:Time Factors; D016896:Treatment Outcome; D019210:Troponin I / Q000097:blood; D016277:Ventricular Function, Left
D015415:Biomarkers; D002317:Cardiovascular Agents; D005338:Fibrin Fibrinogen Degradation Products; D010446:Peptide Fragments; D019210:Troponin I; C033786:fibrinogen Bbeta (15-42)