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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EThe HORIZONS AMI trial showed that bivalirudin therapy in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous intervention (PCI) reduced mortality and bleeding for up to 3 years compared with heparin plus a glycoprotein IIb\/IIIa inhibitor [Stone GW et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2008]. However, according to the results of the European Ambulance Acute Coronary Syndrome Angiography Trial [EUROMAX; Steg PG et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2013], several issues remain. The objective of the EUROMAX trial was to examine whether bivalirudin, initiated in patients with STEMI while being transported in the ambulance for primary PCI, was superior to heparin and provisional use of glycoprotein IIb\/IIIa inhibitors.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EMyocardial Infarction\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EMyocardial Infarction\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology \u0026amp; Cardiovascular Medicine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ECardiology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInterventional Techniques \u0026amp; Devices\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EThe HORIZONS AMI trial showed that bivalirudin therapy in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous intervention (PCI) reduced mortality and bleeding for up to 3 years compared with heparin plus a glycoprotein IIb\/IIIa inhibitor [Stone GW et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2008]. According to Philippe Gabriel Steg, MD, Universite Paris-Diderot, Paris, France, who presented the results of the European Ambulance Acute Coronary Syndrome Angiography Trial [EUROMAX; Steg PG et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2013], several issues remain, including the role of bivalirudin in the ambulance for patients triaged to primary PCI; the potential for reducing the risk of acute stent thrombosis with a prolonged bivalirudin infusion post-PCI; and the impact of contemporary practice (frequent use of radial arterial access and novel oral P2Y12 inhibitors) on the efficacy and safety of bivalirudin.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe objective of the EUROMAX trial was to examine whether bivalirudin, initiated in patients with STEMI while being transported in the ambulance for primary PCI, was superior to heparin and provisional use of glycoprotein IIb\/IIIa inhibitors.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EPatients with STEMI who presented within 12 hours after the onset of symptoms and were scheduled for primary PCI (n=2218) were randomized in the ambulance or at a non-PCI hospital to treatment with bivalirudin (0.75 mg\/kg bolus followed by 1.75 mg\/kg\/hour infusion; n=1089) or to unfractionated heparin with or without a glycoprotein IIb\/IIIa inhibitor (n=1109). To address prior concerns for increased acute stent thrombosis seen in patients treated with bivalirudin in the HORIZONS AMI trial, bivalirudin infusion in EUROMAX was continued post-PCI for at least 4 hours. Bailout use of a glycoprotein IIb\/IIIa inhibitor was also allowed in the bivalirudin group if needed. During the course of the trial, the primary endpoint was changed. The original primary endpoint was the composite endpoint of death, reinfarction, or major bleeding. After a change in the study protocol, the primary and secondary endpoints were switched so that the primary endpoint was the composite of all-cause mortality or major bleeding at 30 days and the key secondary endpoint was mortality, reinfarction, or major bleeding at 30 days. The change in the primary endpoint was made in order to reduce the necessary sample size and occurred while the investigators were still unaware of study outcomes. Major bleeding was defined as intracranial, retroperitoneal, or intraocular bleeding; access-site hemorrhage requiring radiologic or surgical intervention; a reduction in the hemoglobin level of more than 4 g\/dL (2.5 mmol\/L) without an overt source of bleeding or a reduction in the hemoglobin level of more than 3 g\/dL with an overt source of bleeding; reintervention for bleeding; or use of any blood-product transfusion that was not related to coronary artery bypass surgery.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EBaseline characteristics were similar between the two groups, with the exception of diabetes (bivalirudin, 11.7% vs heparin, 15.3%; p\u0026lt;0.05) and prior MI (bivalirudin, 7.4% vs heparin, 10.2%; p\u0026lt;0.05). The primary endpoint occurred in 5.1% of patients treated with bivalirudin compared with 8.5% of those treated with heparin (RR, 0.60; 95% CI, 0.43 to 0.82; p=0.001).\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe secondary endpoint occurred in 6.6% of the bivalirudin group versus 9.2% of the heparin group (RR, 0.72; 95% CI, 0.54 to 0.96; p=0.02). There was no significant difference between the bivalirudin and heparin groups in cardiac deaths (2.5% vs 3.0%; RR, 0.83; 95% CI, 0.50 to 1.38; p=0.48) and noncardiac deaths (0.5% vs 0.1%; RR, 5.09; 95% CI, 0.60 to 43.51; p=0.12). Major bleeding was reported in 2.6% of the bivalirudin groups versus 6.0% of the heparin group (RR, 0.43; 95% CI, 0.28 to 0.66; p\u0026lt;0.001). The composite endpoint of death, reinfarction, ischemia-driven reinfarction, stroke, and major bleeding was reported in 7.8% of the bivalirudin group compared with 10.6% of the heparin group (RR, 0.73; 95% CI, 0.56 to 0.96; p=0.02). The benefits of bivalirudin were consistent across the reported subgroups.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe rate of definite stent thrombosis within 24 hours was higher in the bivalirudin group (1.1%) compared with the heparin group (0.2%; RR, 6.11; 95% CI, 1.37 to 27.24; p=0.007).\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EThe EUROMAX trial had several limitations, including its open-label design. Additionally, the trial was not powered to assess 30-day mortality.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EThis trial showed that in patients with STEMI who were being transported for primary PCI, the initiation of bivalirudin prior to hospital admission reduced the primary endpoint of death or bleeding and the secondary endpoint of death, bleeding, or reinfarction when compared with heparin. However, the rate of acute stent thrombosis was higher with bivalirudin compared with heparin-treated patients. The investigators attributed the benefits of bivalirudin to the substantial reduction in major bleeding. Prof. Steg concluded that these results support the use of bivalirudin for the prehospital management of STEMI prior to primary PCI.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2013 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/13\/19\/18.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nznkap\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}