title: 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.
abstract: 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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Université Paris-Diderot, Sorbonne Paris Cité, Paris, France; INSERM U-698, Paris, France; Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Assistance Publique - Hôpitaux de Paris, Paris, France. Electronic address: gabriel.steg@bch.aphp.fr.
authors.forename: Philippe Gabriel
authors.initials: PG
authors.lastname: Steg
authors.forename: Arnoud
authors.initials: A
authors.lastname: van 't Hof
authors.forename: Peter
authors.initials: P
authors.lastname: Clemmensen
authors.forename: Frédéric
authors.initials: F
authors.lastname: Lapostolle
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.forename: Martial
authors.initials: M
authors.lastname: Hamon
authors.forename: Claudio
authors.initials: C
authors.lastname: Cavallini
authors.forename: Giovanni
authors.initials: G
authors.lastname: Gordini
authors.forename: Kurt
authors.initials: K
authors.lastname: Huber
authors.forename: Pierre
authors.initials: P
authors.lastname: Coste
authors.forename: Michel
authors.initials: M
authors.lastname: Thicoipe
authors.forename: Lutz
authors.initials: L
authors.lastname: Nibbe
authors.forename: Jacob
authors.initials: J
authors.lastname: Steinmetz
authors.forename: Jurrien
authors.initials: J
authors.lastname: Ten Berg
authors.forename: Gerrit Jan
authors.initials: GJ
authors.lastname: Eggink
authors.forename: Uwe
authors.initials: U
authors.lastname: Zeymer
authors.forename: Marco
authors.initials: M
authors.lastname: Campo dell' Orto
authors.forename: Vojko
authors.initials: V
authors.lastname: Kanic
authors.forename: Efthymios N
authors.initials: EN
authors.lastname: Deliargyris
authors.forename: Jonathan
authors.initials: J
authors.lastname: Day
authors.forename: Diana
authors.initials: D
authors.lastname: Schuette
authors.forename: Christian W
authors.initials: CW
authors.lastname: Hamm
authors.forename: Patrick
authors.initials: P
authors.lastname: Goldstein
mesh_terms: D000552:Ambulances; D000925:Anticoagulants / Q000627:therapeutic use*; D000991:Antithrombins / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000627:therapeutic use; D006629:Hirudins; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000188:drug therapy*; D010360:Patient Transfer / Q000379:methods; D010446:Peptide Fragments / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention / Q000379:methods; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin