The basis of this approval is the Horizons-AMI study which was the first drug trial to demonstrate a reduction in deaths from heart attacks in patients undergoing emergency percutaneous coronary intervention (PCI).
The trial showed that patients treated with Angiox compared with today's leading treatment - heparin plus a platelet glycoprotein IIb/IIIa (GPI) inhibitor - were more likely to survive and had less frequent severe bleeds.
Gilles Montalescot, professor of the Pitie-Salpetriere Hopital, France, said: "The HorizonsAMI trial confirms the role of Angiox as an alternative anticoagulant strategy to treat patients with acute myocardial infarction undergoing primary PCI.
"The safety benefit observed with bivalirudin against unfractionated heparin + GPIIb/IIIa inhibitors is a real contribution to interventional cardiology in the contemporary era of evidence based medicine."
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