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Bivalirudin versus heparin monotherapy in non-ST-segment elevation myocardial infarction

Erlinge, David LU ; Koul, Sasha LU ; Omerovic, Elmir ; Fröbert, Ole ; Linder, Rikard ; Danielewicz, Mikael ; Hamid, Mehmet ; Venetsanos, Dimitrios ; Henareh, Loghman and Pettersson, Björn , et al. (2019) In European heart journal. Acute cardiovascular care 8(6). p.492-501
Abstract

BACKGROUND: The optimal anti-coagulation strategy for patients with non-ST-elevation myocardial infarction treated with percutaneous coronary intervention is unclear in contemporary clinical practice of radial access and potent P2Y12-inhibitors. The aim of this study was to investigate whether bivalirudin was superior to heparin monotherapy in patients with non-ST-elevation myocardial infarction without routine glycoprotein IIb/IIIa inhibitor use.

METHODS: In a large pre-specified subgroup of the multicentre, prospective, randomised, registry-based, open-label clinical VALIDATE-SWEDEHEART trial we randomised patients with non-ST-elevation myocardial infarction undergoing percutaneous coronary intervention, treated with ticagrelor... (More)

BACKGROUND: The optimal anti-coagulation strategy for patients with non-ST-elevation myocardial infarction treated with percutaneous coronary intervention is unclear in contemporary clinical practice of radial access and potent P2Y12-inhibitors. The aim of this study was to investigate whether bivalirudin was superior to heparin monotherapy in patients with non-ST-elevation myocardial infarction without routine glycoprotein IIb/IIIa inhibitor use.

METHODS: In a large pre-specified subgroup of the multicentre, prospective, randomised, registry-based, open-label clinical VALIDATE-SWEDEHEART trial we randomised patients with non-ST-elevation myocardial infarction undergoing percutaneous coronary intervention, treated with ticagrelor or prasugrel, to bivalirudin or heparin monotherapy with no planned use of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention. The primary endpoint was the rate of a composite of all-cause death, myocardial infarction or major bleeding within 180 days.

RESULTS: A total of 3001 patients with non-ST-elevation myocardial infarction, were enrolled. The primary endpoint occurred in 12.1% (182 of 1503) and 12.5% (187 of 1498) of patients in the bivalirudin and heparin groups, respectively (hazard ratio of bivalirudin compared to heparin treatment 0.96, 95% confidence interval 0.78-1.18, p=0.69). The results were consistent in all major subgroups. All-cause death occurred in 2.0% versus 1.7% (hazard ratio 1.15, 0.68-1.94, p=0.61), myocardial infarction in 2.3% versus 2.5% (hazard ratio 0.91, 0.58-1.45, p=0.70), major bleeding in 8.9% versus 9.1% (hazard ratio 0.97, 0.77-1.24, p=0.82) and definite stent thrombosis in 0.3% versus 0.2% (hazard ratio 1.33, 0.30-5.93, p=0.82).

CONCLUSION: Bivalirudin as compared to heparin during percutaneous coronary intervention for non-ST-elevation myocardial infarction did not reduce the composite of all-cause death, myocardial infarction or major bleeding in non-ST-elevation myocardial infarction patients receiving current recommended treatments with modern P2Y12-inhibitors and predominantly radial access.

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Contribution to journal
publication status
published
subject
in
European heart journal. Acute cardiovascular care
volume
8
issue
6
pages
492 - 501
publisher
SAGE Publications
external identifiers
  • pmid:30281320
ISSN
2048-8734
DOI
10.1177/2048872618805663
language
English
LU publication?
yes
id
12f78ff2-e49c-4b42-9ee7-755a3ccfc7d3
date added to LUP
2020-06-16 12:01:02
date last changed
2020-09-24 09:08:42
@article{12f78ff2-e49c-4b42-9ee7-755a3ccfc7d3,
  abstract     = {<p>BACKGROUND: The optimal anti-coagulation strategy for patients with non-ST-elevation myocardial infarction treated with percutaneous coronary intervention is unclear in contemporary clinical practice of radial access and potent P2Y12-inhibitors. The aim of this study was to investigate whether bivalirudin was superior to heparin monotherapy in patients with non-ST-elevation myocardial infarction without routine glycoprotein IIb/IIIa inhibitor use.</p><p>METHODS: In a large pre-specified subgroup of the multicentre, prospective, randomised, registry-based, open-label clinical VALIDATE-SWEDEHEART trial we randomised patients with non-ST-elevation myocardial infarction undergoing percutaneous coronary intervention, treated with ticagrelor or prasugrel, to bivalirudin or heparin monotherapy with no planned use of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention. The primary endpoint was the rate of a composite of all-cause death, myocardial infarction or major bleeding within 180 days.</p><p>RESULTS: A total of 3001 patients with non-ST-elevation myocardial infarction, were enrolled. The primary endpoint occurred in 12.1% (182 of 1503) and 12.5% (187 of 1498) of patients in the bivalirudin and heparin groups, respectively (hazard ratio of bivalirudin compared to heparin treatment 0.96, 95% confidence interval 0.78-1.18, p=0.69). The results were consistent in all major subgroups. All-cause death occurred in 2.0% versus 1.7% (hazard ratio 1.15, 0.68-1.94, p=0.61), myocardial infarction in 2.3% versus 2.5% (hazard ratio 0.91, 0.58-1.45, p=0.70), major bleeding in 8.9% versus 9.1% (hazard ratio 0.97, 0.77-1.24, p=0.82) and definite stent thrombosis in 0.3% versus 0.2% (hazard ratio 1.33, 0.30-5.93, p=0.82).</p><p>CONCLUSION: Bivalirudin as compared to heparin during percutaneous coronary intervention for non-ST-elevation myocardial infarction did not reduce the composite of all-cause death, myocardial infarction or major bleeding in non-ST-elevation myocardial infarction patients receiving current recommended treatments with modern P2Y12-inhibitors and predominantly radial access.</p>},
  author       = {Erlinge, David and Koul, Sasha and Omerovic, Elmir and Fröbert, Ole and Linder, Rikard and Danielewicz, Mikael and Hamid, Mehmet and Venetsanos, Dimitrios and Henareh, Loghman and Pettersson, Björn and Wagner, Henrik and Grimfjärd, Per and Jensen, Jens and Hofmann, Robin and Ulvenstam, Anders and Völz, Sebastian and Petursson, Petur and Östlund, Ollie and Sarno, Giovanna and Wallentin, Lars and Scherstén, Fredrik and Eriksson, Peter and James, Stefan},
  issn         = {2048-8734},
  language     = {eng},
  number       = {6},
  pages        = {492--501},
  publisher    = {SAGE Publications},
  series       = {European heart journal. Acute cardiovascular care},
  title        = {Bivalirudin versus heparin monotherapy in non-ST-segment elevation myocardial infarction},
  url          = {http://dx.doi.org/10.1177/2048872618805663},
  doi          = {10.1177/2048872618805663},
  volume       = {8},
  year         = {2019},
}