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| |  FX06 Improves Outcomes After Primary Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction: Presented at ESC By Chris Berrie MUNICH, Germany -- September 5, 2008 -- The fibrin-derived peptide FX06 is safe and well tolerated and significantly reduces necrotic core infarct zone in patients undergoing percutaneous coronary intervention (PCI) for acute ST-segment elevation myocardial infarction (STEMI), according to an international, multicentre, double-blind, randomised, placebo-controlled, phase 2 trial. The study's findings were presented here on September 2 at the European Society of Cardiology 2008 Congress (ESC) by Dan Atar, MD, Aker University Hospital, University of Oslo, Oslo, Norway, on behalf of the FX06 in ischemia and Reperfusion study investigators. "Early reperfusion by PCI is the treatment of choice for STEMI, and sudden reinitiation of blood flow achieved with PCI can lead to further myocardial damage, termed reperfusion injury," he said. As FX06 can preserve endothelial barrier function and has anti-inflammatory effects, Dr. Atar and colleagues conducted their study to investigate the cardioprotective efficacy of FX06 as an adjunct to reperfusion therapy in patients with acute STEMI. They enrolled patients with a first myocardial infarction undergoing primary PCI, who had a single lesion with complete occlusion of 1 target vessel, pain to balloon time <6 hours, and ST-segment elevation of 2 mm or greater in 3 or more leads on an electrocardiogram. The primary outcome was infarct size, measured by contrast-enhanced magnetic resonance imaging after 5 days. Secondary outcomes included myocardial scar at 4 months, left ventricular (LV) function at 5 days and 4 months, biomarkers, and a combination of major adverse cardiac event. A total of 120 patients with a mean age of 59.8 years (male, 80.0%) were randomised to placebo, and 114 patients with a mean age of 60.0 years (male, 72.8%) received FX06 400 mg IV. Baseline patient characteristics, concomitant medications, and procedural data were well balanced between the 2 treatment groups. In the intention-to-treat population, at 5 days there were no significant differences between FX06 and placebo for total late enhancement zone (21.68 vs 27.34 g, respectively) and incidence of microvascular obstruction (27.6% vs 37.5%). However, the necrotic core was significantly reduced in the FX06 group (1.77 vs 4.20 g; P = .019). At 4 months post-PCI, there were no significant differences for total late enhancement zone (15.37 vs 19.32 g) and scar mass (1.79 vs 2.84 g). The LV ejection fraction was well preserved in all patients at this analysis (49.6% vs 48.6%). "This represents a very high ejection fraction in these infarction patients and is testimony to very successful recanalisation," added Dr. Atar. There were no significant reductions in the biomarkers of cardiac necrosis, troponin I, and creatine kinase myocardial branch. For clinical outcomes, there were no significant differences in the 2 treatment groups for major adverse cardiac event. Similarly, rates of all-cause mortality were similar (2.6% vs 4.2%), and there were no differences in adverse events and serious adverse events between FX06 and placebo. Dr. Atar concluded, "This study may suggest a cardioprotective role of FX06 as an adjunct to PCI, as most likely this effect occurred while reducing reperfusion injury." Funding for this study was provided by Fibrex Medical Research & Development GmbH. [Presentation title: A Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Measure the Effect of FX06 on Ischaemia Reperfusion Injury in Patients With Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention (The F.I.R.E. Trial). Abstract 3212]
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