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European heart journal · Sep 2014
Randomized Controlled Trial Multicenter Study Comparative StudyBivalirudin 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.
- 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, and Philippe Gabriel Steg.
- Klinikum Ludwigshafen, Institut für Herzinfarktforschung Ludwigshafen, Bremser Str. 79, Ludwigshafen 67063, Germany zeymeru@klilu.de.
- Eur. Heart J. 2014 Sep 21; 35 (36): 2460-7.
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.© The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology.
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