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

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 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.

• Authors: David Erlinge, Sasha Koul, Elmir Omerovic, Ole Fröbert, Rikard Linder, Mikael Danielewicz, Mehmet Hamid, Dimitrios Venetsanos, Loghman Henareh, Björn Pettersson, Henrik Wagner, Per Grimfjärd, Jens Jensen, Robin Hofmann, Anders Ulvenstam, Sebastian Völz, Petur Petursson, Ollie Östlund, Giovanna Sarno, Lars Wallentin, Fredrik Scherstén, Peter Eriksson, Stefan James
• Journal: European heart journal. Acute cardiovascular care (Eur Heart J Acute Cardiovasc Care) Vol. 8 Issue 6 Pg. 492-501 (Sep 2019) ISSN: 2048-8734 [Electronic] England
• PMID: 30281320 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anticoagulants
• Antithrombins
• Hirudins
• Peptide Fragments
• Platelet Aggregation Inhibitors
• Platelet Glycoprotein GPIIb-IIIa Complex
• Purinergic P2Y Receptor Antagonists
• Recombinant Proteins
• Heparin
• Prasugrel Hydrochloride
• Ticagrelor
• bivalirudin

Topics

• Aged
• Anticoagulants (therapeutic use)
• Antithrombins (therapeutic use)
• Female
• Hemorrhage (epidemiology)
• Heparin (therapeutic use)
• Hirudins
• Humans
• Male
• Myocardial Infarction (epidemiology)
• Non-ST Elevated Myocardial Infarction (drug therapy)
• Peptide Fragments (therapeutic use)
• Percutaneous Coronary Intervention (methods)
• Platelet Aggregation Inhibitors (therapeutic use)
• Platelet Glycoprotein GPIIb-IIIa Complex (antagonists & inhibitors)
• Prasugrel Hydrochloride (therapeutic use)
• Purinergic P2Y Receptor Antagonists (therapeutic use)
• Recombinant Proteins (therapeutic use)
• Stents (adverse effects)
• Sweden (epidemiology)
• Thrombosis
• Ticagrelor (therapeutic use)