BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI) triaged to primarypercutaneous 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.
RCT Entities:
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.
Authors: Uwe Zeymer; Arnoud van 't Hof; Jennifer Adgey; Lutz Nibbe; Peter Clemmensen; Claudio Cavallini; Jurrien ten Berg; Pierre Coste; Kurt Huber; Efthymios N Deliargyris; Jonathan Day; Debra Bernstein; Patrick Goldstein; Christian Hamm; Philippe Gabriel Steg Journal: Eur Heart J Date: 2014-05-21 Impact factor: 29.983
Authors: Stephanie Armstrong; Adele Langlois; Despina Laparidou; Mark Dixon; Jason P Appleton; Philip M Bath; Helen Snooks; A Niroshan Siriwardena Journal: BMC Med Res Methodol Date: 2017-09-16 Impact factor: 4.615