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Eur Heart J. 2014 Sep 21;35(36):2460-7. doi: 10.1093/eurheartj/ehu214. Epub 2014 May 21.

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.

Author information

1
Klinikum Ludwigshafen, Institut für Herzinfarktforschung Ludwigshafen, Bremser Str. 79, Ludwigshafen 67063, Germany zeymeru@klilu.de.
2
Department of Cardiology, Isala Klinieken, The Netherlands.
3
Royal Victoria Hospital, Belfast, UK.
4
Department of Nephrology and Medical Intensive Care, Charité, Campus Virchow-Klinikum, Universitätsmedizin Berlin, Berlin, Germany.
5
Department of Cardiology, Institute for Clinical Medicine, University of Copenhagen, Rigshospitalet, Copenhagen.
6
Ospedale Perugia, Italy.
7
Zwolle, St. Antonius Hospital, Nieuwegein, The Netherlands.
8
Hôpital Cardiologique-Centre Hospitalier Universitaire Bordeaux, Université de Bordeaux, Pessac, France.
9
3rd Department of Medicine, Cardiology, Wilhelminenhospital, Vienna.
10
The Medicines Company, Parsippany, NJ, USA.
11
The Emergency Department and SAMU, Lille University Hospital, Lille.
12
Department of Cardiology, Kerckhoff Clinic and Thoraxcenter, Bad Nauheim, Germany.
13
Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France Département Hospitalo-Universitaire FIRE, Université Paris-Diderot, INSERM U-1148, Paris, France NHLI, Imperial College, Royal Brompton Hospital, London, UK.

Abstract

AIMS:

In 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 RESULTS:

In 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).

CONCLUSION:

Bivalirudin, 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.

KEYWORDS:

Bivalirudin; Glycoprotein IIb/IIIa inhibitors; Heparins; Primary percutaneous coronary intervention; ST-segment elevation myocardial infarction

PMID:
24849104
PMCID:
PMC4169872
DOI:
10.1093/eurheartj/ehu214
[Indexed for MEDLINE]
Free PMC Article

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