ACC: Bivalirudin associated with reductions in cardiac death, major bleeding in STEMI patients undergoing PCI

Prof. Steg

Compared to a combination of heparin and a glycoprotein (GP) IIb/IIIa inhibitor, use of bivalirudin (Angiomax) is associated with significant absolute reductions in risk for cardiac death and major non-coronary artery bypass graft (CABG) bleeding, according to data presented at the American College of Cardiology 63rd Annual Scientific Session (ACC.14), in Washington, D.C.

“The totality of the findings in this analysis confirm the earlier findings of the EUROMAX and HORIZONS-AMI trials, and support the fact that bivalirudin should remain the preferred anticoagulant of choice for clinicians treating STEMI patients undergoing primary PCI,” said Prof. Gabriel Steg, MD, of Hôpital Bichat in Paris in a statement.

In a pooled analysis of 5,800 patients from the EUROMAX and HORIZONS-AMI trials, 2 international clinical trials comparing bivalirudin versus heparin with or without GP IIb/IIIa inhibitors in patients with ST-segment elevation acute myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI), data showed a significant absolute reduction in cardiac death of 0.9%; absolute reduction in major non-CABG-related bleeding of 3.6%; absolute reduction in transfusion of 1.7%; and absolute reduction in net adverse clinical events (NACE) of 3.1%. The analysis also showed an increased risk of stent thrombosis, driven by an increase in acute stent thrombosis absolute risk of 1.0%. The findings were consistent across all examined subgroups.

“Despite the increase in acute stent thrombosis, the reduction in CV mortality is present and in itself should be sufficient to prefer bivalirudin in this setting,” said Prof. Steg. “If your default strategy for these patients is heparin with GPI, you should switch to a bivalirudin strategy.”

EUROMAX (EUROpean aMbulance Acs angioX trial) and HORIZONS-AMI studies were presented and published individually in September 2008 and October 2013, in The Lancet and The New England Journal of Medicine respectively.

EUROMAX was a 2,218 randomized, controlled, open-label, international, multicenter study that compared early administration of bivalirudin, which is marketed as Angiox in the European Union, and Angiomax in the US, to heparins with or without GP inhibitors. Patients with STEMI who were being transported for primary PCI received either bivalirudin or unfractionated or low-molecular-weight heparin with optional GP inhibitor (control group). At 30 days, the primary outcome was a composite of death or major bleeding not associated with CABG, and the principal secondary outcome was a composite of death, reinfarction, or non-CABG major bleeding.

HORIZONS-AMI, co-funded by a grant from The Medicines Company, was the largest study to focus on the appropriate use of anticoagulation medications and stents in patients experiencing STEMI and undergoing primary PCI. This landmark trial was a prospective, single-blind, randomized, multicenter study conducted in 11 countries. Patients undergoing angioplasty were randomly assigned to receive either bivalirudin with provisional use of GP inhibitor or heparin plus GP inhibitor. Patients enrolled in the HORIZONS-AMI trial also were assigned randomly to receive either Taxus drug-eluting stents or a bare-metal stent. The 2 primary end points of the trial were major bleeding and net adverse clinical events, a composite of major adverse cardiovascular events (death, reinfarction, stroke or ischemic target vessel revascularization) and major bleeding at 30 days. The major secondary end point was major adverse cardiovascular events at 30 days.