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 Day; Diana Schuette; Christian W Hamm; Patrick Goldstein

doi:10.1016/j.ahj.2013.08.025

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

Department of Clinical Medicine

11 Citations (Scopus)

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. 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.

Original language	English
Journal	American Heart Journal
Volume	166
Issue number	6
Pages (from-to)	960–967.e6
Number of pages	8
ISSN	0002-8703
DOIs	https://doi.org/10.1016/j.ahj.2013.08.025
Publication status	Published - Dec 2013

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Steg, P. G., van 't Hof, A., Clemmensen, P., Lapostolle, F., Dudek, D., Hamon, M., Cavallini, C., Gordini, G., Huber, K., Coste, P., Thicoipe, M., Nibbe, L., Steinmetz, J., Ten Berg, J., Eggink, G. J., Zeymer, U., Campo Dell' Orto, M., Kanic, V., Deliargyris, E. N., ... Goldstein, P. (2013). 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 . American Heart Journal, 166(6), 960–967.e6. https://doi.org/10.1016/j.ahj.2013.08.025

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 . / Steg, Philippe Gabriel; van 't Hof, Arnoud; Clemmensen, Peter et al.

In: American Heart Journal, Vol. 166, No. 6, 12.2013, p. 960–967.e6.

Research output: Contribution to journal › Journal article › Research › peer-review

Steg, PG, van 't Hof, A, Clemmensen, P, Lapostolle, F, Dudek, D, Hamon, M, Cavallini, C, Gordini, G, Huber, K, Coste, P, Thicoipe, M, Nibbe, L, Steinmetz, J, Ten Berg, J, Eggink, GJ, Zeymer, U, Campo Dell' Orto, M, Kanic, V, Deliargyris, EN, Day, J, Schuette, D, Hamm, CW & Goldstein, P 2013, '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 ', American Heart Journal, vol. 166, no. 6, pp. 960–967.e6. https://doi.org/10.1016/j.ahj.2013.08.025

Steg PG, van 't Hof A, Clemmensen P, Lapostolle F, Dudek D, Hamon M et al. 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 . American Heart Journal. 2013 Dec;166(6): 960–967.e6. doi: 10.1016/j.ahj.2013.08.025

Steg, Philippe Gabriel ; van 't Hof, Arnoud ; Clemmensen, Peter et al. / 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 . In: American Heart Journal. 2013 ; Vol. 166, No. 6. pp. 960–967.e6.

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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. 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.",

author = "Steg, {Philippe Gabriel} and {van 't Hof}, Arnoud and Peter Clemmensen and Fr{\'e}d{\'e}ric Lapostolle and Dariusz Dudek and Martial Hamon and Claudio Cavallini and Giovanni Gordini and Kurt Huber and Pierre Coste and Michel Thicoipe and Lutz Nibbe and Jacob Steinmetz and {Ten Berg}, Jurrien and Eggink, {Gerrit Jan} and Uwe Zeymer and {Campo Dell' Orto}, Marco and Vojko Kanic and Deliargyris, {Efthymios N} and Jonathan Day and Diana Schuette and Hamm, {Christian W} and Patrick Goldstein",

year = "2013",

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doi = "10.1016/j.ahj.2013.08.025",

language = "English",

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TY - JOUR

T1 - Design and methods of European Ambulance Acute Coronary Syndrome Angiography Trial (EUROMAX)

T2 - 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

AU - Steg, Philippe Gabriel

AU - van 't Hof, Arnoud

AU - Clemmensen, Peter

AU - Lapostolle, Frédéric

AU - Dudek, Dariusz

AU - Hamon, Martial

AU - Cavallini, Claudio

AU - Gordini, Giovanni

AU - Huber, Kurt

AU - Coste, Pierre

AU - Thicoipe, Michel

AU - Nibbe, Lutz

AU - Steinmetz, Jacob

AU - Ten Berg, Jurrien

AU - Eggink, Gerrit Jan

AU - Zeymer, Uwe

AU - Campo Dell' Orto, Marco

AU - Kanic, Vojko

AU - Deliargyris, Efthymios N

AU - Day, Jonathan

AU - Schuette, Diana

AU - Hamm, Christian W

AU - Goldstein, Patrick

PY - 2013/12

Y1 - 2013/12

N2 - 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.

AB - 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.

U2 - 10.1016/j.ahj.2013.08.025

DO - 10.1016/j.ahj.2013.08.025

M3 - Journal article

SN - 0002-8703

VL - 166

SP - 960–967.e6

JO - American Heart Journal

JF - American Heart Journal

IS - 6

ER -