No reduction in composite of all-cause death, new myocardial infarction; increase in bleeding
TUESDAY, Sept. 3 (HealthDay News) -- For patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) undergoing a planned early invasive strategy, the novel intravenous direct factor Xa inhibitor otamixaban does not reduce the rate of ischemic events compared with unfractionated heparin plus eptifibatide, according to a study published online Sept. 1 in the Journal of the American Medical Association to coincide with presentation at the annual European Society of Cardiology Congress, held from Aug. 31 to Sept. 4 in Amsterdam.
Philippe Gabriel Steg, M.D., from the Université Paris-Diderot, and colleagues conducted a randomized trial that enrolled 13,229 patients with NSTE-ACS at 568 active sites in 55 countries. Participants were randomized to otamixaban (bolus and infusion; 5,105 patients) or unfractionated heparin plus eptifibatide at the time of percutaneous coronary intervention (5,466 patients).
The researchers found that the rates of a composite of all-cause death or new myocardial infarction through day seven were 5.5 percent in otamixaban-treated patients and 5.7 percent in unfractionated-heparin-plus-eptifibatide-treated patients (adjusted relative risk, 0.99; P = 0.93). No differences were seen between the groups with respect to secondary end points, including procedural thrombotic complications. Otamixaban correlated with a significant increase in the primary safety outcome of Thrombosis in Myocardial Infarction major or minor bleeding (3.1 versus 1.5 percent; relative risk, 2.13). Consistent results were seen across pre-specified subgroups.
"These findings do not support the use of otamixaban for patients with NSTE-ACS undergoing planned early percutaneous coronary intervention," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including sanofi, which funded the study.
Abstract (http://jama.jamanetwork.com/article.aspx?articleid=1734212#Abstract )Full Text (http://jama.jamanetwork.com/article.aspx?articleid=1734212 )More Information (http://www.escardio.org/ESC2013 )