Bivalirudin Started during Emergency Transport for Primary PCI

Philippe Gabriel Steg; Arnoud van 't Hof; Christian W Hamm; Peter Clemmensen; Frédéric Lapostolle; Pierre Coste; Jurrien Ten Berg; Pierre Van Grunsven; Gerrit Jan Eggink; Lutz Nibbe; Uwe Zeymer; Marco Campo Dell' Orto; Holger Nef; Jacob Steinmetz; Louis Soulat; Kurt Huber; Efthymios N Deliargyris; Debra Bernstein; Diana Schuette; Jayne Prats; Tim Clayton; Stuart Pocock; Martial Hamon; Patrick Goldstein; the EUROMAX Investigators

doi:10.1056/nejmoa1311096

Bivalirudin Started during Emergency Transport for Primary PCI

Philippe Gabriel Steg, Arnoud van 't Hof, Christian W Hamm, Peter Clemmensen, Frédéric Lapostolle, Pierre Coste, Jurrien Ten Berg, Pierre Van Grunsven, Gerrit Jan Eggink, Lutz Nibbe, Uwe Zeymer, Marco Campo Dell' Orto, Holger Nef, Jacob Steinmetz, Louis Soulat, Kurt Huber, Efthymios N Deliargyris, Debra Bernstein, Diana Schuette, Jayne PratsTim Clayton, Stuart Pocock, Martial Hamon, Patrick Goldstein, the EUROMAX Investigators

Department of Clinical Medicine

376 Citations (Scopus)

Abstract

BACKGROUND: Bivalirudin, as compared with heparin and glycoprotein IIb/IIIa inhibitors, has been shown to reduce rates of bleeding and death in patients undergoing primary percutaneous coronary intervention (PCI). Whether these benefits persist in contemporary practice characterized by prehospital initiation of treatment, optional use of glycoprotein IIb/IIIa inhibitors and novel P2Y₁₂ inhibitors, and radial-artery PCI access use is unknown. METHODS: We randomly assigned 2218 patients with ST-segment elevation myocardial infarction (STEMI) who were being transported for primary PCI to receive either bivalirudin or unfractionated or low-molecular-weight heparin with optional glycoprotein IIb/IIIa inhibitors (control group). The primary outcome at 30 days was a composite of death or major bleeding not associated with coronary-artery bypass grafting (CABG), and the principal secondary outcome was a composite of death, reinfarction, or non-CABG major bleeding. RESULTS: Bivalirudin, as compared with the control intervention, reduced the risk of the primary outcome (5.1% vs. 8.5%; relative risk, 0.60; 95% confidence interval [CI], 0.43 to 0.82; P=0.001) and the principal secondary outcome (6.6% vs. 9.2%; relative risk, 0.72; 95% CI, 0.54 to 0.96; P=0.02). Bivalirudin also reduced the risk of major bleeding (2.6% vs. 6.0%; relative risk, 0.43; 95% CI, 0.28 to 0.66; P<0.001). The risk of acute stent thrombosis was higher with bivalirudin (1.1% vs. 0.2%; relative risk, 6.11; 95% CI, 1.37 to 27.24; P=0.007). There was no significant difference in rates of death (2.9% vs. 3.1%) or reinfarction (1.7% vs. 0.9%). Results were consistent across subgroups of patients. CONCLUSIONS: Bivalirudin, started during transport for primary PCI, improved 30-day clinical outcomes with a reduction in major bleeding but with an increase in acute stent thrombosis.

Original language	English
Journal	New England Journal of Medicine
Volume	369
Issue number	23
Pages (from-to)	2207-2217
Number of pages	11
ISSN	0028-4793
DOIs	https://doi.org/10.1056/nejmoa1311096
Publication status	Published - 2013

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Steg, P. G., van 't Hof, A., Hamm, C. W., Clemmensen, P., Lapostolle, F., Coste, P., Berg, J. T., Van Grunsven, P., Eggink, G. J., Nibbe, L., Zeymer, U., Orto, M. C. D., Nef, H., Steinmetz, J., Soulat, L., Huber, K., Deliargyris, E. N., Bernstein, D., Schuette, D., ... Investigators, T. EUROMAX. (2013). Bivalirudin Started during Emergency Transport for Primary PCI. New England Journal of Medicine, 369(23), 2207-2217. https://doi.org/10.1056/nejmoa1311096

Steg, PG, van 't Hof, A, Hamm, CW, Clemmensen, P, Lapostolle, F, Coste, P, Berg, JT, Van Grunsven, P, Eggink, GJ, Nibbe, L, Zeymer, U, Orto, MCD, Nef, H, Steinmetz, J, Soulat, L, Huber, K, Deliargyris, EN, Bernstein, D, Schuette, D, Prats, J, Clayton, T, Pocock, S, Hamon, M, Goldstein, P & Investigators, TEUROMAX 2013, 'Bivalirudin Started during Emergency Transport for Primary PCI', New England Journal of Medicine, vol. 369, no. 23, pp. 2207-2217. https://doi.org/10.1056/nejmoa1311096

@article{189aae4d23de427abefb439b35275b56,

title = "Bivalirudin Started during Emergency Transport for Primary PCI",

abstract = "BACKGROUND: Bivalirudin, as compared with heparin and glycoprotein IIb/IIIa inhibitors, has been shown to reduce rates of bleeding and death in patients undergoing primary percutaneous coronary intervention (PCI). Whether these benefits persist in contemporary practice characterized by prehospital initiation of treatment, optional use of glycoprotein IIb/IIIa inhibitors and novel P2Y12 inhibitors, and radial-artery PCI access use is unknown. METHODS: We randomly assigned 2218 patients with ST-segment elevation myocardial infarction (STEMI) who were being transported for primary PCI to receive either bivalirudin or unfractionated or low-molecular-weight heparin with optional glycoprotein IIb/IIIa inhibitors (control group). The primary outcome at 30 days was a composite of death or major bleeding not associated with coronary-artery bypass grafting (CABG), and the principal secondary outcome was a composite of death, reinfarction, or non-CABG major bleeding. RESULTS: Bivalirudin, as compared with the control intervention, reduced the risk of the primary outcome (5.1% vs. 8.5%; relative risk, 0.60; 95% confidence interval [CI], 0.43 to 0.82; P=0.001) and the principal secondary outcome (6.6% vs. 9.2%; relative risk, 0.72; 95% CI, 0.54 to 0.96; P=0.02). Bivalirudin also reduced the risk of major bleeding (2.6% vs. 6.0%; relative risk, 0.43; 95% CI, 0.28 to 0.66; P<0.001). The risk of acute stent thrombosis was higher with bivalirudin (1.1% vs. 0.2%; relative risk, 6.11; 95% CI, 1.37 to 27.24; P=0.007). There was no significant difference in rates of death (2.9% vs. 3.1%) or reinfarction (1.7% vs. 0.9%). Results were consistent across subgroups of patients. CONCLUSIONS: Bivalirudin, started during transport for primary PCI, improved 30-day clinical outcomes with a reduction in major bleeding but with an increase in acute stent thrombosis.",

author = "Steg, {Philippe Gabriel} and {van 't Hof}, Arnoud and Hamm, {Christian W} and Peter Clemmensen and Fr{\'e}d{\'e}ric Lapostolle and Pierre Coste and Berg, {Jurrien Ten} and {Van Grunsven}, Pierre and Eggink, {Gerrit Jan} and Lutz Nibbe and Uwe Zeymer and Orto, {Marco Campo Dell'} and Holger Nef and Jacob Steinmetz and Louis Soulat and Kurt Huber and Deliargyris, {Efthymios N} and Debra Bernstein and Diana Schuette and Jayne Prats and Tim Clayton and Stuart Pocock and Martial Hamon and Patrick Goldstein and Investigators, {the EUROMAX}",

year = "2013",

doi = "10.1056/nejmoa1311096",

language = "English",

volume = "369",

pages = "2207--2217",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "23",

}

TY - JOUR

T1 - Bivalirudin Started during Emergency Transport for Primary PCI

AU - Steg, Philippe Gabriel

AU - van 't Hof, Arnoud

AU - Hamm, Christian W

AU - Clemmensen, Peter

AU - Lapostolle, Frédéric

AU - Coste, Pierre

AU - Berg, Jurrien Ten

AU - Van Grunsven, Pierre

AU - Eggink, Gerrit Jan

AU - Nibbe, Lutz

AU - Zeymer, Uwe

AU - Orto, Marco Campo Dell'

AU - Nef, Holger

AU - Steinmetz, Jacob

AU - Soulat, Louis

AU - Huber, Kurt

AU - Deliargyris, Efthymios N

AU - Bernstein, Debra

AU - Schuette, Diana

AU - Prats, Jayne

AU - Clayton, Tim

AU - Pocock, Stuart

AU - Hamon, Martial

AU - Goldstein, Patrick

AU - Investigators, the EUROMAX

PY - 2013

Y1 - 2013

N2 - BACKGROUND: Bivalirudin, as compared with heparin and glycoprotein IIb/IIIa inhibitors, has been shown to reduce rates of bleeding and death in patients undergoing primary percutaneous coronary intervention (PCI). Whether these benefits persist in contemporary practice characterized by prehospital initiation of treatment, optional use of glycoprotein IIb/IIIa inhibitors and novel P2Y12 inhibitors, and radial-artery PCI access use is unknown. METHODS: We randomly assigned 2218 patients with ST-segment elevation myocardial infarction (STEMI) who were being transported for primary PCI to receive either bivalirudin or unfractionated or low-molecular-weight heparin with optional glycoprotein IIb/IIIa inhibitors (control group). The primary outcome at 30 days was a composite of death or major bleeding not associated with coronary-artery bypass grafting (CABG), and the principal secondary outcome was a composite of death, reinfarction, or non-CABG major bleeding. RESULTS: Bivalirudin, as compared with the control intervention, reduced the risk of the primary outcome (5.1% vs. 8.5%; relative risk, 0.60; 95% confidence interval [CI], 0.43 to 0.82; P=0.001) and the principal secondary outcome (6.6% vs. 9.2%; relative risk, 0.72; 95% CI, 0.54 to 0.96; P=0.02). Bivalirudin also reduced the risk of major bleeding (2.6% vs. 6.0%; relative risk, 0.43; 95% CI, 0.28 to 0.66; P<0.001). The risk of acute stent thrombosis was higher with bivalirudin (1.1% vs. 0.2%; relative risk, 6.11; 95% CI, 1.37 to 27.24; P=0.007). There was no significant difference in rates of death (2.9% vs. 3.1%) or reinfarction (1.7% vs. 0.9%). Results were consistent across subgroups of patients. CONCLUSIONS: Bivalirudin, started during transport for primary PCI, improved 30-day clinical outcomes with a reduction in major bleeding but with an increase in acute stent thrombosis.

AB - BACKGROUND: Bivalirudin, as compared with heparin and glycoprotein IIb/IIIa inhibitors, has been shown to reduce rates of bleeding and death in patients undergoing primary percutaneous coronary intervention (PCI). Whether these benefits persist in contemporary practice characterized by prehospital initiation of treatment, optional use of glycoprotein IIb/IIIa inhibitors and novel P2Y12 inhibitors, and radial-artery PCI access use is unknown. METHODS: We randomly assigned 2218 patients with ST-segment elevation myocardial infarction (STEMI) who were being transported for primary PCI to receive either bivalirudin or unfractionated or low-molecular-weight heparin with optional glycoprotein IIb/IIIa inhibitors (control group). The primary outcome at 30 days was a composite of death or major bleeding not associated with coronary-artery bypass grafting (CABG), and the principal secondary outcome was a composite of death, reinfarction, or non-CABG major bleeding. RESULTS: Bivalirudin, as compared with the control intervention, reduced the risk of the primary outcome (5.1% vs. 8.5%; relative risk, 0.60; 95% confidence interval [CI], 0.43 to 0.82; P=0.001) and the principal secondary outcome (6.6% vs. 9.2%; relative risk, 0.72; 95% CI, 0.54 to 0.96; P=0.02). Bivalirudin also reduced the risk of major bleeding (2.6% vs. 6.0%; relative risk, 0.43; 95% CI, 0.28 to 0.66; P<0.001). The risk of acute stent thrombosis was higher with bivalirudin (1.1% vs. 0.2%; relative risk, 6.11; 95% CI, 1.37 to 27.24; P=0.007). There was no significant difference in rates of death (2.9% vs. 3.1%) or reinfarction (1.7% vs. 0.9%). Results were consistent across subgroups of patients. CONCLUSIONS: Bivalirudin, started during transport for primary PCI, improved 30-day clinical outcomes with a reduction in major bleeding but with an increase in acute stent thrombosis.

U2 - 10.1056/nejmoa1311096

DO - 10.1056/nejmoa1311096

M3 - Journal article

C2 - 24171490

SN - 0028-4793

VL - 369

SP - 2207

EP - 2217

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 23

ER -

Bivalirudin Started during Emergency Transport for Primary PCI

Abstract

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