Design and methods of European Ambulance Acute Coronary Syndrome Angiography Trial (EUROMAX): An international randomized open-label ambulance trial of bivalirudin versus standard-of-care anticoagulation in patients with acute ST-segment-elevation myocardial infarction transferred for primary percutaneous coronary intervention

Philippe Gabriel Steg, Arnoud Van'T Hof, Peter Clemmensen, Frédéric Lapostolle, Dariusz Dudek, Martial Hamon, Claudio Cavallini, Giovanni Gordini, Kurt Huber, Pierre Coste, Michel Thicoipe, Lutz Nibbe, Jacob Steinmetz, Jurrien Ten Berg, Gerrit Jan Eggink, Uwe Zeymer, Marco Campo Dell'Orto, Vojko Kanic, Efthymios N. Deliargyris, Jonathan DayDiana Schuette, Christian W. Hamm, Patrick Goldstein

    Publikation: Bidrag til tidsskriftArtikelForskningpeer review

    Abstrakt

    Background In patients with ST-segment elevation myocardial infarction (STEMI) triaged to primary percutaneous coronary intervention (PCI), anticoagulation often is initiated in the ambulance during transfer to a PCI site. In this prehospital setting, bivalirudin has not been compared with standard-of-care anticoagulation. In addition, it has not been tested in conjunction with the newer P2Y12 inhibitors prasugrel or ticagrelor. Design EUROMAX is a randomized, international, prospective, open-label ambulance trial comparing bivalirudin with standard-of-care anticoagulation with or without glycoprotein IIb/IIIa inhibitors in 2200 patients with STEMI and intended for primary percutaneous coronary intervention (PCI), presenting either via ambulance or to centers where PCI is not performed. Patients will receive either bivalirudin given as a 0.75 mg/kg bolus followed immediately by a 1.75-mg/kg per hour infusion for ≥30 minutes prior to primary PCI and continued for ≥4 hours after the end of the procedure at the reduced dose of 0.25 mg/kg per hour, or heparins at guideline-recommended doses, with or without routine or bailout glycoprotein IIb/IIIa inhibitor treatment according to local practice. The primary end point is the composite incidence of death or non-coronary-artery-bypass-graft related protocol major bleeding at 30 days by intention to treat. Conclusion The EUROMAX trial will test whether bivalirudin started in the ambulance and continued for 4 hours after primary PCI improves clinical outcomes compared with guideline-recommended standard-of-care heparin-based regimens, and will also provide information on the combination of bivalirudin with prasugrel or ticagrelor.

    OriginalsprogEngelsk
    Sider (fra-til)960-967.e6
    TidsskriftAmerican heart journal
    Vol/bind166
    Udgave nummer6
    DOI
    StatusUdgivet - dec. 2013

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