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; Hof, Arnoud van ’t; Clemmensen, Peter; Lapostolle, Frédéric; Dudek, Dariusz; Hamon, Martial; Cavallini, Claudio; Gordini, Giovanni; Huber, Kurt; Coste, Pierre; Thicoïpé, M.; Nibbe, Lutz; Steinmetz, Jacob; Berg, Jurriën Ten; Eggink, Gerrit; Zeymer, Uwe; Orto, Marco Campo dell’; Kanic, Vojko; Deliargyris, Efthymios N.; Day, Jonathan; Schuette, Diana; Hamm, Christian W.; Goldstein, Patrick

doi:10.1016/j.ahj.2013.08.025

Cited by 15 publications

(19 citation statements)

References 41 publications

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“…8,11 Continuous variables are reported as medians and interquartile ranges. Categorical variables are reported as frequencies and percentages.…”

Section: Discussionmentioning

confidence: 99%

“…11 In brief, patients ≥18 years presenting with ST-segment-elevation acute coronary syndrome intended for primary PCI within 2 hours of first medical contact were randomized to bivalirudin or heparins with optional GPI. The study was approved by an Institutional Review Board and all patients provided initial abridged written or oral consent, which was then subsequently confirmed by a formal written informed consent.…”

Section: Methodsmentioning

confidence: 99%

“…Detailed definitions of the individual end points have been previously published. 11 All deaths, bleeding, reinfarction, ischemia-driven revascularization, stent thrombosis, and strokes were adjudicated by an independent, blinded Clinical Events Committee.…”

Section: What the Study Addsmentioning

confidence: 99%

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Impact of Arterial Access Site on Outcomes After Primary Percutaneous Coronary Intervention

Hamon

Coste

Hof

et al. 2015

Circ: Cardiovascular Interventions

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Background-In European Ambulance Acute Coronary Syndrome Angiography (EUROMAX), bivalirudin improved 30-day clinical outcomes with reduced major bleeding compared with heparins plus optional glycoprotein IIb/IIIa inhibitors. We assessed whether choice of access site (radial or femoral) had an impact on 30-day outcomes and whether it interacted with the benefit of bivalirudin. Methods and Results-In EUROMAX, choice of arterial access was left to operator discretion. Overall, 47% of patients underwent radial and 53% femoral access. Baseline risk was higher in the femoral access group. Unadjusted proportions for the primary outcome (death or noncoronary artery bypass graft protocol major bleeding at 30 days) were lower with radial access, however, without differences in major or major plus minor bleeding proportions. After multivariable adjustment, ischemic outcomes were no longer different between access site groups, except for a lower risk of stroke in radial patients. Bivalirudin was associated with lower proportions of the primary outcome in both the radial (odds ratio, 0.58; 95% CI, 0.33-1.03; P=0.058) and the femoral groups (odds ratio, 0.59; 95% CI, 0.37-0.93; P=0.022; interaction P=0.97). Bleeding was significantly lower in the bivalirudin group both in the radial-and femoral-treated patients but no significant difference was observed in ischemic outcomes. In multivariable analysis, bivalirudin emerged as the only independent predictor of reduced major bleeding (odds ratio, 0.45; 95% CI, 0.27-0.74; P=0.002). Conclusions-In this prespecified analysis from EUROMAX, radial access was preferred in lower risk patients and did not improve clinical outcomes. Bivalirudin was associated with less bleeding irrespective of access site. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01087723.(Circ Cardiovasc Interv. 2015;8:e002049.

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“…8,11 Continuous variables are reported as medians and interquartile ranges. Categorical variables are reported as frequencies and percentages.…”

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Impact of Arterial Access Site on Outcomes After Primary Percutaneous Coronary Intervention

Hamon

Coste

Hof

et al. 2015

Circ: Cardiovascular Interventions

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“…6 Moreover, cardiovascular mortality was reduced after 30 days and at 3-year follow-up. 7 However, the use of GPI is not always routine in clinical practice anymore and might have contributed to the increase in bleeding complications seen in the control arm. In the EUROMAX trial, the use of GPI was not mandated, but was left to the standard practice of participating centres.…”

Section: Introductionmentioning

confidence: 99%

Bivalirudin is superior to heparins alone with bailout GP IIb/IIIa inhibitors in patients with ST-segment elevation myocardial infarction transported emergently for primary percutaneous coronary intervention: a pre-specified analysis from the EUROMAX trial

Zeymer

Hof

Adgey

et al. 2014

European Heart Journal

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AimsIn the HORIZONS trial, in-hospital treatment with bivalirudin reduced bleeding and mortality in primary percutaneous coronary intervention (PCI) compared with heparin and routine glycoprotein IIb/IIIa inhibitors (GPI). It is unknown whether this advantage of bivalirudin is observed in comparison with heparins only with GPI used as bailout.Methods and resultsIn the EUROMAX study, 2198 patients with ST-segment elevation myocardial infarction (STEMI) were randomized during transport for primary PCI to bivalirudin or to heparins with optional GPI. Primary and principal outcome was the composites of death or non-CABG-related major bleeding at 30 days. This pre-specified analysis compared patients receiving bivalirudin (n = 1089) with those receiving heparins with routine upstream GPI (n = 649) and those receiving heparins only with GPI use restricted to bailout (n = 460). The primary outcome death and major bleeding occurred in 5.1% with bivalirudin, 7.6% with heparin plus routine GPI (HR 0.67 and 95% CI 0.46–0.97, P = 0.034), and 9.8% with heparins plus bailout GPI (HR 0.52 and 95% CI 0.35–0.75, P = 0.006). Following adjustment by logistic regression, bivalirudin was still associated with significantly lower rates of the primary outcome (odds ratio 0.53, 95% CI 0.33–0.87) and major bleeding (odds ratio 0.44, 95% CI 0.24–0.82) compared with heparins alone with bailout GPI. Rates of stent thrombosis were higher with bivalirudin (1.6 vs. 0.6 vs. 0.4%, P = 0.09 and 0.09).ConclusionBivalirudin, started during transport for primary PCI, reduces major bleeding compared with both patients treated with heparin only plus bailout GPI and patients treated with heparin and routine GPI, but increased stent thrombosis.

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“…Another large study, the EUROMAX (European Ambulance Acute Coronary Syndrome Angiography) trial, tested in 2,218 STEMI patients whether prehospital administration of bivalirudin continued for 4 hours after primary PCI improves clinical outcomes compared with the guideline-recommended UFH or enoxaparin [24]. The investigators revealed that bivalirudin, as compared with the control intervention, reduced the risk of the primary outcome, which was a composite of death or major bleeding not associated with coronary artery bypass grafting (CABG) at 30 days, (5.1% v. 8.5%; RR 0.60; 95% CI 0.43-0.82; p = 0.001) and the principal secondary outcome, defined as a composite of death, re-MI, or non-CABG major bleeding (6.6% v. 9.2%; RR 0.72; 95% CI 0.54-0.96; p = 0.02).…”

Section: Results Of Initial Randomized Clinical Trials: a Rising Star…mentioning

confidence: 99%

A systematic review on the role of bivalirudin in patients undergoing percutaneous coronary interventions: primus inter pares or a falling star?

Obońska

Koziński²,

Obońska³

et al. 2015

Medical Research Journal

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Intracoronary thrombosis triggered by ruptured or eroded atherosclerotic plaques constitutes the predominant underlying cause of acute coronary syndromes (ACS). Thrombin is considered a central enzyme in hemostasis and thrombosis, and a well-established target for anticoagulant therapies. Bivalirudin was introduced in the clinical practice as a promising, reversible, direct thrombin inhibitor with a predictable anticoagulant effect. Initial randomized clinical trials demonstrated that bivalirudin compared with heparin on top of a glycoprotein IIb/IIIa inhibitor was associated with a significant reduction of major bleeding and favorable net clinical outcomes in patients undergoing percutaneous coronary interventions (PCI). The HORIZON-AMI trial even indicated mortality benefit in bivalirudin-treated patients. Thereby, the 2011 and 2012 European Society of Cardiology Guidelines on the management of non-ST-segment elevation ACS and ST-segment elevation myocardial infarction positioned bivalirudin as the anticoagulant of choice in the PCI setting. Further randomized studies, better reflecting routine clinical practice, revealed significantly increased rates of stent thrombosis and myocardial infarction in the bivalirudin arm. Additionally, these findings were corroborated in the subsequent meta-analyses. Speculations that excessive occurrence of stent thrombosis and myocardial infarction may be caused by too short duration of post PCI bivalirudin infusion did not find confirmation in the latest MATRIX trial. In this systematic review, we aim to assess the efficacy and safety of bivalirudin therapy in patients undergoing PCI and to formulate recommendations on the bivalirudin use for clinicians. In our opinion, the research evidence and pharmacoeconomic considerations strongly support the use of bivalirudin in PCI patients at high risk of bleeding complications, while in other situations old and inexpensive UFH or enoxaparin remain the first line antithrombotic drugs.

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Cited by 15 publications

References 41 publications

Impact of Arterial Access Site on Outcomes After Primary Percutaneous Coronary Intervention

Impact of Arterial Access Site on Outcomes After Primary Percutaneous Coronary Intervention

Bivalirudin is superior to heparins alone with bailout GP IIb/IIIa inhibitors in patients with ST-segment elevation myocardial infarction transported emergently for primary percutaneous coronary intervention: a pre-specified analysis from the EUROMAX trial

A systematic review on the role of bivalirudin in patients undergoing percutaneous coronary interventions: primus inter pares or a falling star?

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