The CHMP has issued a positive opinion for Angiox (bivalirudin) for use in heart attack patients undergoing emergency heart procedures.
The recommendation could extend the use of Angiox (bivalirudin) to include patients with heart attacks (so-called ST segment elevation myocardial infarction) undergoing an emergency heart procedure called primary percutaneous coronary intervention (PCI).
The basis of the approval is the HORIZONS-AMI study, the first drug trial to demonstrate a reduction in deaths from heart attacks in patients undergoing emergency PCI. The trial showed that patients treated with Angiox compared with today’s leading treatment – heparin plus a platelet glycoprotein IIb/IIIa inhibitor (GPI) – were more likely to survive and had less frequent severe bleeds.
Professeur Ph. Gabriel Steg, from Centre Hôpitalier Bichat in Paris, France, commented: “The sustained reduction in all-cause and cardiovascular mortality achieved by bivalirudin in the context of primary PCI, compared to the standard of care, provides a compelling case for switching to bivalirudin as the preferred anticoagulant for primary PCI.”
The HORIZONS-AMI trial compared Angiox to heparin plus a GPI in 3,602 patients presenting with the most severe form of heart attack, ST segment elevation myocardial infarction (STEMI), undergoing an emergency (primary) PCI. Results at 30 days showed that Angiox significantly improved overall mortality, including a reduction in the incidence of heart-related deaths by 38% (1.8% vs. 2.9%).
Angiox also reduced the incidence of major bleeding by 42%, reduced the incidence of adverse clinical events by 26%, and demonstrated comparable rates of major adverse cardiac events.
Long-term results of the data have recently been published, including one-year data in The Lancet and two-year data presented at the 2009 Transcatheter Cardiovascular Therapeutics (TCT) conference. These data show a significant 38% reduction in cardiac mortality at 30 days, which was maintained at 43% (at one year) and 41% (at two years).
“The HORIZONS-AMI 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,” said Professor Gilles Montalescot of the Pitié-Salpêtrière Hôpital, France.