PARIS. - Thursday, May 22nd 2014 [ME NewsWire]
(BUSINESS WIRE) During the Late Breaking Clinical Trial sessions at EuroPCR yesterday and published simultaneously in the European Heart Journal, Professor Uwe Zeymer of Klinikum Ludwigshafen, Ludwigshafen, Germany and others reported a paper entitled: “Bivalirudin is superior to heparins alone with bailout GP IIb/IIIa inhibitors in patients with ST-segment elevation myocardial infarction transported emergently for primary percutaneous coronary intervention: a pre-specified analysis from the EUROMAX trial”.
The EUROMAX trial studied 2,198 patients with heart attacks (STEMI) during their transport on the way to urgent heart procedures (PPCI) aimed at unblocking coronary arteries occluded by blood clots – the underlying cause of heart attacks. Treatment with bivalirudin (Angiox) was compared to heparin or low-molecular weight heparin (heparins) given with optional glycoprotein inhibitors (GPI). As reported in The New England Journal of Medicine last year, the trial met all of its pre-specified endpoints.
Lead author and presenter of the new analysis Dr Uwe Zeymer MD, of Klinikum Ludwigshafen, Ludwigshafen, Germany said, ‘’The results of this pre-specified subgroup analysis are consistent with the overall trial results. Bivalirudin resulted in significantly lower rates of the primary outcome and major bleeding regardless of routine or bailout only use of GPI.”
Principal investigator of the EUROMAX trial Professor P. Gabriel Steg, MD, of Hôpital Bichat in Paris said, "The results of this pre-specified subgroup analysis are in keeping with the overall trial results and provide evidence that the reductions in the primary endpoint and protocol major bleeding seen with bivalirudin over heparin are consistent regardless of the use of GPI. However, the 1% absolute increase in acute stent thrombosis observed in the overall EUROMAX trial was also seen in this pre-specified analysis.”
In the United States, bivalirudin is marketed under the trade name Angiomax® and is indicated in patients undergoing PCI with provisional use of GPI and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is also indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA. Please see full prescribing information for Angiomax, available at http://www.angiomax.com.
In Europe, bivalirudin is marketed under the trade name Angiox® and is indicated as an anticoagulant for adult patients undergoing PCI, including patients with STEMI undergoing primary PCI. Angiox is also indicated for the treatment of adult patients with unstable angina/non-ST segment elevation MI planned for urgent or early intervention. Please see full prescribing information available at http://www.angiox.com.
In clinical trials comparing Angiomax and heparin, the most common adverse reaction for Angiomax was bleeding (28%). Other common adverse reactions were headache, thrombocytopenia and fever. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax should be used with caution in patients with disease states associated with an increased risk of bleeding.
In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components.
EUROMAX (EUROpean aMbulance Acs angioX trial) was a 2,218 randomized, controlled, open label, international, multicenter study that compared early administration of bivalirudin, which is marketed as Angiox in the European Union, and Angiomax in the US, to heparins with or without glycoprotein inhibitors (GPI). Patients with ST-segment elevation myocardial infarction (STEMI) who were being transported for primary PCI received either bivalirudin or unfractionated or low-molecular-weight heparin with optional GPI (control group). At 30 days, the primary outcome was a composite of death or major bleeding not associated with coronary-artery bypass grafting (CABG), and the principal secondary outcome was a composite of death, reinfarction, or non-CABG major bleeding. Patients who were assigned to the bivalirudin group received a bolus of 0.75 mg per kilogram, followed by an infusion of 1.75 mg per kilogram 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 per kilogram 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.
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