Angiox/Angiomax (Medicines Company) results from EUROMAX trial for AMI

The Medicines Company announced results from the EUROMAX Trial, a 2,218 patient Phase IIIb randomized study of the Company's Angiox (bivalirudin), which is marketed as Angiomax (bivalirudin) in the US. The trial met its pre-specified primary and secondary endpoints, including statistically significant reductions in the primary composite endpoint of death and major bleeding among patients randomized to Angiox. Results were presented as a Late-Breaking Clinical Trial at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) Scientific Symposium and were published simultaneously in The New England Journal of Medicine.

The EUROMAX trial compared administration of Angiox to heparin or low-molecular weight heparin (heparins) with optional glycoprotein inhibitors (GPI) started during emergency transport in patients with STEMI, the most severe form of heart attack, undergoing primary percutaneous coronary intervention (PCI).

Bivalirudin, as compared with the control intervention, reduced the risk of the primary outcome (5.1% vs. 8.5%; relative risk, 0.60; 95% confidence interval [CI], 0.43 to 0.82; P=0.001) and the principal secondary outcome (6.6% vs. 9.2%; relative risk, 0.72; 95% CI, 0.54 to 0.96; P=0.02). Bivalirudin also reduced the risk of major bleeding (2.6% vs. 6.0%; relative risk, 0.43; 95% CI, 0.28 to 0.66; P<0.001). the risk of acute stent thrombosis was higher with bivalirudin (1.1% vs. 0.2%; relative risk, 6.11; 95% ci, 1.37 to 27.24; p="0.007)." there was no significant difference in rates of death (2.9% vs. 3.1%) or reinfarction (1.7% vs. 0.9%). results were consistent across subgroups of patients.>

The EUROMAX results open up the way to using bivalirudin as an anticoagulant at the pre-hospital phase of myocardial infarction in patients being urgently transferred.