title: ST-segment resolution with bivalirudin versus heparin and routine glycoprotein IIb/IIIa inhibitors started in the ambulance in ST-segment elevation myocardial infarction patients transported for primary percutaneous coronary intervention: The EUROMAX ST-segment resolution substudy.
abstract: BACKGROUND
  Myocardial reperfusion after primary percutaneous coronary intervention (PCI) can be assessed by the extent of post-procedural ST-segment resolution. The European Ambulance Acute Coronary Syndrome Angiography (EUROMAX) trial compared pre-hospital bivalirudin and pre-hospital heparin or enoxaparin with or without GPIIb/IIIa inhibitors (GPIs) in primary PCI. This nested substudy was performed in centres routinely using pre-hospital GPI in order to compare the impact of randomized treatments on ST-resolution after primary PCI.
  
  
  METHODS
  Residual cumulative ST-segment deviation on the single one hour post-procedure electrocardiogram (ECG) was assessed by an independent core laboratory and was the primary endpoint. It was calculated that 762 evaluable patients were needed to show non-inferiority (85% power, alpha 2.5%) between randomized treatments.
  
  
  RESULTS
  A total of 871 participated with electrocardiographic data available in 824 patients (95%). Residual ST-segment deviation one hour after PCI was 3.8±4.9 mm versus 3.9±5.2 mm for bivalirudin and heparin+GPI, respectively ( p=0.0019 for non-inferiority). Overall, there were no differences between randomized treatments in any measures of ST-segment resolution either before or after the index procedure.
  
  
  CONCLUSIONS
  Pre-hospital treatment with bivalirudin is non-inferior to pre-hospital heparin + GPI with regard to residual ST-segment deviation or ST-segment resolution, reflecting comparable myocardial reperfusion with the two strategies.
authors.affiliation: 1 Isala Hospital, The Netherlands.
authors.forename: Arnoud
authors.initials: A
authors.lastname: Van't Hof
authors.affiliation: 1 Isala Hospital, The Netherlands.
authors.forename: Francesco
authors.initials: F
authors.lastname: Giannini
authors.affiliation: 2 St Antonius Hospital, The Netherlands.
authors.forename: Jurrien
authors.initials: J
authors.lastname: Ten Berg
authors.affiliation: 3 EMS RAV IJsselland, The Netherlands.
authors.forename: Rudolf
authors.initials: R
authors.lastname: Tolsma
authors.affiliation: 4 The Heart Centre, Copenhagen University Hospital, Denmark.
authors.forename: Peter
authors.initials: P
authors.lastname: Clemmensen
authors.affiliation: 5 The Medicines Company, USA.
authors.forename: Debra
authors.initials: D
authors.lastname: Bernstein
authors.affiliation: 6 Centre Hospitalier Universitaire Bordeaux, Université de Bordeaux, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Coste
authors.affiliation: 7 Centre Hospitalier Régional Universitaire de Lille, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Goldstein
authors.affiliation: 8 Klinikum Ludwigshafen, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Zeymer
authors.affiliation: 9 Kerckhoff Heart and Thoraxcenter, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Hamm
authors.affiliation: 5 The Medicines Company, USA.
authors.forename: Efthymios
authors.initials: E
authors.lastname: Deliargyris
authors.affiliation: 10 Université Paris-Diderot, France.
authors.forename: Philippe G
authors.initials: PG
authors.lastname: Steg
mesh_terms: D000077284:Abciximab; D000368:Aged; D000552:Ambulances; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D000925:Anticoagulants / Q000008:administration & dosage; D000991:Antithrombins / Q000008:administration & dosage; D017023:Coronary Angiography; D004305:Dose-Response Relationship, Drug; D004562:Electrocardiography / Q000187:drug effects*; D004632:Emergency Medical Services / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006493:Heparin / Q000008:administration & dosage*; D006629:Hirudins / Q000008:administration & dosage*; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000008:administration & dosage*; D062645:Percutaneous Coronary Intervention; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D011994:Recombinant Proteins / Q000008:administration & dosage; D012189:Retrospective Studies; D000072657:ST Elevation Myocardial Infarction / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D013997:Time Factors; D014187:Transportation of Patients; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D007140:Immunoglobulin Fab Fragments; D010446:Peptide Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin; D000077284:Abciximab
keywords: ST-segment resolution; bivalirudin; heparins; percutaneous coronary intervention