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Bivalirudin versus heparin monotherapy in myocardial infarction

Erlinge, D. LU ; Omerovic, E.; Fröbert, Ole; Linder, R.; Danielewicz, Mikael; Abdel-Hamid, Mohamed; Swahn, E.; Henareh, L.; Wagner, H. LU and Hårdhammar, Peter, et al. (2017) In New England Journal of Medicine 377(12). p.1132-1142
Abstract

BACKGROUND: The comparative efficacy of various anticoagulation strategies has not been clearly established in patients with acute myocardial infarction who are undergoing percutaneous coronary intervention (PCI) according to current practice, which includes the use of radial-artery access for PCI and administration of potent P2Y12 inhibitors without the planned use of glycoprotein IIb/IIIa inhibitors. METHODS: In this multicenter, randomized, registry-based, open-label clinical trial, we enrolled patients with either ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) who were undergoing PCI and receiving treatment with a potent... (More)

BACKGROUND: The comparative efficacy of various anticoagulation strategies has not been clearly established in patients with acute myocardial infarction who are undergoing percutaneous coronary intervention (PCI) according to current practice, which includes the use of radial-artery access for PCI and administration of potent P2Y12 inhibitors without the planned use of glycoprotein IIb/IIIa inhibitors. METHODS: In this multicenter, randomized, registry-based, open-label clinical trial, we enrolled patients with either ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) who were undergoing PCI and receiving treatment with a potent P2Y12 inhibitor (ticagrelor, prasugrel, or cangrelor) without the planned use of glycoprotein IIb/IIIa inhibitors. The patients were randomly assigned to receive bivalirudin or heparin during PCI, which was performed predominantly with the use of radial-artery access. The primary end point was a composite of death from any cause, myocardial infarction, or major bleeding during 180 days of follow-up. RESULTS: A total of 6006 patients (3005 with STEMI and 3001 with NSTEMI) were enrolled in the trial. At 180 days, a primary end-point event had occurred in 12.3% of the patients (369 of 3004) in the bivalirudin group and in 12.8% (383 of 3002) in the heparin group (hazard ratio, 0.96; 95% confidence interval [CI], 0.83 to 1.10; P=0.54). The results were consistent between patients with STEMI and those with NSTEMI and across other major subgroups. Myocardial infarction occurred in 2.0% of the patients in the bivalirudin group and in 2.4% in the heparin group (hazard ratio, 0.84; 95% CI, 0.60 to 1.19; P=0.33), major bleeding in 8.6% and 8.6%, respectively (hazard ratio, 1.00; 95% CI, 0.84 to 1.19; P=0.98), definite stent thrombosis in 0.4% and 0.7%, respectively (hazard ratio, 0.54; 95% CI, 0.27 to 1.10; P=0.09), and death in 2.9% and 2.8%, respectively (hazard ratio, 1.05; 95% CI, 0.78 to 1.41; P=0.76). CONCLUSIONS: Among patients undergoing PCI for myocardial infarction, the rate of the composite of death from any cause, myocardial infarction, or major bleeding was not lower among those who received bivalirudin than among those who received heparin monotherapy.

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published
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New England Journal of Medicine
volume
377
issue
12
pages
1132 - 1142
publisher
Massachusetts Medical Society
external identifiers
  • scopus:85029571113
  • wos:000411348500007
ISSN
0028-4793
DOI
10.1056/NEJMoa1706443
language
English
LU publication?
yes
id
e4ba7cdd-12bf-4a3c-a9f5-319872ffbbb8
date added to LUP
2017-10-10 16:14:56
date last changed
2018-09-02 04:42:13
@article{e4ba7cdd-12bf-4a3c-a9f5-319872ffbbb8,
  abstract     = {<p>BACKGROUND: The comparative efficacy of various anticoagulation strategies has not      been      clearly established in patients with acute myocardial infarction who are undergoing      percutaneous      coronary intervention (PCI) according to current practice, which includes      the      use of radial-artery access for PCI and administration of potent P2Y<sub>12</sub> inhibitors      without      the planned use of glycoprotein IIb/IIIa inhibitors. METHODS: In this multicenter,      randomized,      registry-based, open-label clinical trial, we enrolled patients with      either      ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) who      were      undergoing PCI and receiving treatment with a potent P2Y<sub>12</sub> inhibitor (ticagrelor,      prasugrel,      or cangrelor) without the planned use of glycoprotein IIb/IIIa inhibitors.      The      patients were randomly assigned to receive bivalirudin or heparin during PCI,      which      was performed predominantly with the use of radial-artery access. The primary      end      point was a composite of death from any cause, myocardial infarction, or major      bleeding      during 180 days of follow-up. RESULTS: A total of 6006 patients (3005 with      STEMI      and 3001 with NSTEMI) were enrolled in the trial. At 180 days, a primary end-point      event      had occurred in 12.3% of the patients (369 of 3004) in the bivalirudin group      and      in 12.8% (383 of 3002) in the heparin group (hazard ratio, 0.96; 95% confidence      interval      [CI], 0.83 to 1.10; P=0.54). The results were consistent between patients      with      STEMI and those with NSTEMI and across other major subgroups. Myocardial infarction      occurred      in 2.0% of the patients in the bivalirudin group and in 2.4% in the heparin      group      (hazard ratio, 0.84; 95% CI, 0.60 to 1.19; P=0.33), major bleeding in 8.6%      and      8.6%, respectively (hazard ratio, 1.00; 95% CI, 0.84 to 1.19; P=0.98), definite      stent      thrombosis in 0.4% and 0.7%, respectively (hazard ratio, 0.54; 95% CI, 0.27      to      1.10; P=0.09), and death in 2.9% and 2.8%, respectively (hazard ratio, 1.05; 95%      CI,      0.78 to 1.41; P=0.76). CONCLUSIONS: Among patients undergoing PCI for myocardial      infarction,      the rate of the composite of death from any cause, myocardial infarction,      or      major bleeding was not lower among those who received bivalirudin than among those      who      received heparin monotherapy.</p>},
  author       = {Erlinge, D. and Omerovic, E. and Fröbert, Ole and Linder, R. and Danielewicz, Mikael and Abdel-Hamid, Mohamed and Swahn, E. and Henareh, L. and Wagner, H. and Hårdhammar, Peter and Sjögren, Iwar and Stewart, J. and Grimfjärd, Per and Jensen, J. and Aasa, Mikael and Robertsson, L and Lindroos, P. and Haupt, Jan and Wikström, H. and Ulvenstam, A. and Bhiladvala, P. and Lindvall, B. and Lundin, A. and Tödt, T. and Ioanes, D. and Råmunddal, Truls and Kellerth, Thomas and Zagozdzon, L. and Götberg, M. and Andersson, J. and Angerås, Oskar and Östlund, Olof and Lagerqvist, B. and Held, Claes and Wallentin, L. and Scherstén, F. and Eriksson, P. and Koul, S. and James, S},
  issn         = {0028-4793},
  language     = {eng},
  month        = {09},
  number       = {12},
  pages        = {1132--1142},
  publisher    = {Massachusetts Medical Society},
  series       = {New England Journal of Medicine},
  title        = {Bivalirudin versus heparin monotherapy in myocardial infarction},
  url          = {http://dx.doi.org/10.1056/NEJMoa1706443},
  volume       = {377},
  year         = {2017},
}