title: Bivalirudin started during emergency transport for primary PCI.
abstract: BACKGROUND
  Bivalirudin, as compared with heparin and glycoprotein IIb/IIIa inhibitors, has been shown to reduce rates of bleeding and death in patients undergoing primary percutaneous coronary intervention (PCI). Whether these benefits persist in contemporary practice characterized by prehospital initiation of treatment, optional use of glycoprotein IIb/IIIa inhibitors and novel P2Y12 inhibitors, and radial-artery PCI access use is unknown.
  
  
  METHODS
  We randomly assigned 2218 patients with ST-segment elevation myocardial infarction (STEMI) who were being transported for primary PCI to receive either bivalirudin or unfractionated or low-molecular-weight heparin with optional glycoprotein IIb/IIIa inhibitors (control group). The primary outcome at 30 days 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.
  
  
  RESULTS
  Bivalirudin, as compared with the control intervention, reduced the risk of the primary outcome (5.1% vs. 8.5%; relative risk, 0.60; 95% confidence interval [CI], 0.43 to 0.82; P=0.001) and the principal secondary outcome (6.6% vs. 9.2%; relative risk, 0.72; 95% CI, 0.54 to 0.96; P=0.02). Bivalirudin also reduced the risk of major bleeding (2.6% vs. 6.0%; relative risk, 0.43; 95% CI, 0.28 to 0.66; P<0.001). The risk of acute stent thrombosis was higher with bivalirudin (1.1% vs. 0.2%; relative risk, 6.11; 95% CI, 1.37 to 27.24; P=0.007). There was no significant difference in rates of death (2.9% vs. 3.1%) or reinfarction (1.7% vs. 0.9%). Results were consistent across subgroups of patients.
  
  
  CONCLUSIONS
  Bivalirudin, started during transport for primary PCI, improved 30-day clinical outcomes with a reduction in major bleeding but with an increase in acute stent thrombosis. (Funded by the Medicines Company; EUROMAX ClinicalTrials.gov number, NCT01087723.).
authors.affiliation: The authors' affiliations are listed in the Appendix.
authors.forename: Philippe Gabriel
authors.initials: PG
authors.lastname: Steg
authors.forename: Arnoud
authors.initials: A
authors.lastname: van 't Hof
authors.forename: Christian W
authors.initials: CW
authors.lastname: Hamm
authors.forename: Peter
authors.initials: P
authors.lastname: Clemmensen
authors.forename: Frédéric
authors.initials: F
authors.lastname: Lapostolle
authors.forename: Pierre
authors.initials: P
authors.lastname: Coste
authors.forename: Jurrien
authors.initials: J
authors.lastname: Ten Berg
authors.forename: Pierre
authors.initials: P
authors.lastname: Van Grunsven
authors.forename: Gerrit Jan
authors.initials: GJ
authors.lastname: Eggink
authors.forename: Lutz
authors.initials: L
authors.lastname: Nibbe
authors.forename: Uwe
authors.initials: U
authors.lastname: Zeymer
authors.forename: Marco
authors.initials: M
authors.lastname: Campo dell' Orto
authors.forename: Holger
authors.initials: H
authors.lastname: Nef
authors.forename: Jacob
authors.initials: J
authors.lastname: Steinmetz
authors.forename: Louis
authors.initials: L
authors.lastname: Soulat
authors.forename: Kurt
authors.initials: K
authors.lastname: Huber
authors.forename: Efthymios N
authors.initials: EN
authors.lastname: Deliargyris
authors.forename: Debra
authors.initials: D
authors.lastname: Bernstein
authors.forename: Diana
authors.initials: D
authors.lastname: Schuette
authors.forename: Jayne
authors.initials: J
authors.lastname: Prats
authors.forename: Tim
authors.initials: T
authors.lastname: Clayton
authors.forename: Stuart
authors.initials: S
authors.lastname: Pocock
authors.forename: Martial
authors.initials: M
authors.lastname: Hamon
authors.forename: Patrick
authors.initials: P
authors.lastname: Goldstein
mesh_terms: D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use*; D001026:Coronary Artery Bypass; D003328:Coronary Thrombosis / Q000209:etiology; D004632:Emergency Medical Services; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced / Q000517:prevention & control; D006493:Heparin / Q000627:therapeutic use; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000401:mortality / Q000628:therapy; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D015607:Stents; D014187:Transportation of Patients
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin