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.
OBJECTIVE
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.


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).


CONCLUSIONS
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.
Klinikum Ludwigshafen, Institut für Herzinfarktforschung Ludwigshafen, Bremser Str. 79, Ludwigshafen 67063, Germany zeymeru@klilu.de.
Uwe
U
Zeymer
Department of Cardiology, Isala Klinieken, The Netherlands.
Arnoud
A
van 't Hof
Royal Victoria Hospital, Belfast, UK.
Jennifer
J
Adgey
Department of Nephrology and Medical Intensive Care, Charité, Campus Virchow-Klinikum, Universitätsmedizin Berlin, Berlin, Germany.
Lutz
L
Nibbe
Department of Cardiology, Institute for Clinical Medicine, University of Copenhagen, Rigshospitalet, Copenhagen.
Peter
P
Clemmensen
Ospedale Perugia, Italy.
Claudio
C
Cavallini
Zwolle, St. Antonius Hospital, Nieuwegein, The Netherlands.
Jurrien
J
ten Berg
Hôpital Cardiologique-Centre Hospitalier Universitaire Bordeaux, Université de Bordeaux, Pessac, France.
Pierre
P
Coste
3rd Department of Medicine, Cardiology, Wilhelminenhospital, Vienna.
Kurt
K
Huber
The Medicines Company, Parsippany, NJ, USA.
Efthymios N
EN
Deliargyris
The Medicines Company, Parsippany, NJ, USA.
Jonathan
J
Day
The Medicines Company, Parsippany, NJ, USA.
Debra
D
Bernstein
The Emergency Department and SAMU, Lille University Hospital, Lille.
Patrick
P
Goldstein
Department of Cardiology, Kerckhoff Clinic and Thoraxcenter, Bad Nauheim, Germany.
Christian
C
Hamm
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.
Philippe Gabriel
PG
Steg
D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D000991:Antithrombins / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D004638:Emergency Treatment; D005260:Female; D006493:Heparin / Q000627:therapeutic use*; D006629:Hirudins; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000601:surgery; D010446:Peptide Fragments / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D011994:Recombinant Proteins / Q000627:therapeutic use; D014187:Transportation of Patients
D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin
Bivalirudin; Glycoprotein IIb/IIIa inhibitors; Heparins; Primary percutaneous coronary intervention; ST-segment elevation myocardial infarction