EUROMAX 30-Day Results Meet Endpoints for Bivalirudin

October 30, 2013—The Medicines Company (Parsippany, NJ) announced that results from the EUROMAX trial were presented by Principal Investigator Professor Philippe Gabriel Steg, MD, as a late-breaking clinical trial at the TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California. The results were published simultaneously online by Prof. Steg, et al in The New England Journal of Medicine.

According to the Medicines Company, EUROMAX is a 2,218-patient randomized, controlled, open-label, international, multicenter, phase IIIb study comparing administration of the company's Angiox (bivalirudin), which is marketed as Angiomax in the United States, to unfractionated or low-molecular-weight heparin (heparins) with optional glycoprotein inhibitors (GPI) started during emergency transport in patients with ST-segment elevated myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). At 30 days, the primary outcome was a composite of death or major bleeding not associated with coronary artery bypass graft (CABG) surgery, and the principal secondary outcome was a composite of death, reinfarction, or non-CABG major bleeding.

Patients who were assigned to the Angiox group received a bolus of 0.75 mg/kg, followed by an infusion of 1.75 mg/kg per hour, which should be continued for at least 4 hours after PCI. The protocol also specified that the dose during the post-PCI interval should be 0.25 mg/kg per hour; however, continuation of the higher dose used during PCI was also permitted. Bailout use of a GPI was allowed in the event of giant thrombus or no reflow.

The company reported that the EUROMAX trial met its prespecified primary and secondary endpoints, including statistically significant reductions in the primary composite endpoint of death and major bleeding among patients randomized to Angiox. Patients treated with Angiox versus heparin showed a 40% relative risk reduction (5.1% vs 8.5%; P = .001) in the primary composite endpoint of death and non-CABG-related bleeding 30 days after their PCI. There was a 28% relative risk reduction in the principal secondary composite outcomes of death, reinfarction, or major bleeding (6.6% vs 9.2%; P = .02) and a 57% relative risk reduction of major bleeding (2.6% vs 6%; P < .001).

“EUROMAX was a large, international, randomized trial in acute myocardial infarction management with early triage and initiation of therapy, in a contemporary treatment setting in which half the patients underwent PCI via the radial access approach and received either prasugrel or ticagrelor, one of the new P2Y12 inhibitors,” Prof. Steg, of Hôpital Bichat in Paris, France, said in the company's press release. “These results pave the way for routine use of bivalirudin as an anticoagulant during the prehospital phase of acute myocardial infarction management, during transport of patients for emergency primary angioplasty.”