THURSDAY, Jan. 29 (HealthDay News) -- In patients undergoing percutaneous coronary intervention to treat acute ST-segment elevation myocardial infarction (STEMI), using intravenous FX06, a fibrin-derived naturally occurring peptide, significantly reduces the necrotic core zone, but does not change scar size or troponin I levels, according to study findings published online Jan. 28 in the Journal of the American College of Cardiology.
Dan Atar, M.D., Ph.D., of the University of Oslo in Oslo, Norway, and colleagues conducted a study of 234 patients undergoing treatment for acute STEMI, who were randomized to receive either FX06 or placebo as an intravenous bolus at the time of reperfusion.
In the treatment group, there was a 58 percent reduction in the necrotic core zone compared to the placebo group, but 48-hour troponin I levels were similar between the two groups, and after a period of four months scar size was also comparable between the placebo and treatment group patients, the investigators report. The drug was well tolerated and adverse effects were similar for the two groups, the authors note.
"Although this study did not show a significant reduction in the total late gadolinium enhanced zone, it did show a reduction of necrotic core size after injection of FX06 as an adjunct to standard care in STEMI patients undergoing percutaneous coronary intervention," Atar and colleagues write. "These findings warrant further scrutiny in an adequately powered dose-finding and clinical outcome trial."
Several of the study authors report a financial relationship with Fibrex Medical, the manufacturer of FX06.