Pooled analysis supports use of bivalirudin in STEMI

WASHINGTON — Bivalirudin was associated with reduced mortality and major bleeding compared with heparin with or without a glycoprotein IIb/IIIa inhibitor in patients with STEMI undergoing primary PCI, according to results of a pooled analysis of the EUROMAX and HORIZONS-AMI trials presented here.

P. Gabriel Steg, MD, of Bichat Hospital and the University of Paris, presented the findings and suggested that safe and effective anticoagulation in patients with STEMI undergoing primary PCI is necessary for reducing complications and improving survival outcomes. The current presentation reported on two recent trials — EUROMAX and HORIZONS-AMI — that investigated the most commonly used anticoagulation regimens in patients undergoing primary PCI: unfractionated heparin with or without a glycoprotein IIb/IIIa inhibitor (GPI) and bivalirudin (Angiomax, The Medicines Company) monotherapy.

The current study included 5,800 patients from the two studies. Steg, who is an Editorial Board member of Cardiology Today’s Intervention, and researchers conducted a 30-day patient-level pooled analysis of outcomes from the two investigations.

P. Gabriel Steg

Death or non-CABG major bleeding served as the primary outcome measure in the EUROMAX study.

Heparin ± GPI yielded a 10.4% rate of the primary outcome vs. 6.4% for bivalirudin (P<.0001). For the key secondary outcome — death/MI/protocol non-CABG major bleeding — the rates were 11.4% for the heparin regimen and 7.8% for bivalirudin (P<.0001).

There were two co-primary endpoints in the HORIZONS-AMI trial: The first was a composite of death, MI, ischemia-driven revascularization, stroke and non-CABG major bleeding, and the second was protocol non-CABG major bleeding. For the first endpoint, the rates were 12.3% for the heparin regimen and 9.1% for bivalirudin (P=.0001). For the second, it was 8.2% for heparin and 4.2% for bivalirudin (P<.0001).

Steg noted that in the overall pooled analysis, acute stent thrombosis was 0.2% for the heparin ± GPI regimen and 1.3% for bivalirudin (P<.0001).

“The message is very simple: The benefits we saw in both [the EUROMAX and HORIZONS-AMI] trials were maintained in the pooled analysis,” Steg told Cardiology Today’s Intervention. “There was a reduction in the primary outcome of EUROMAX that combines death and major bleeding. There was also a benefit on HORIZONS-AMI for two co-primary outcomes: major bleeding, which was markedly reduced by bivalirudin compared to [unfractionated heparin], and the other co-primary outcome, which was net adverse clinical events.”

Perhaps most importantly, Steg added that there was a benefit in terms of CV mortality in the pooled analysis. “Additionally, we noted that there was a reduction in transfusion … [and] a reduction in thrombocytopenia with bivalirudin,” he said.

Regarding the rise in stent thrombosis, Steg noted that the events all occurred within 4 hours of infusion.

For more information:

Steg PG. Abstract Session 920: ACS Therapies — Year in Review and Novel Potential Strategies. Presented at: American College of Cardiology Scientific Sessions ; March 29-31, 2014; Washington, DC.

Disclosure: Steg reports serving as a consultant, speaker and committee member for The Medicines Company, and consulting and speaker services for several manufacturers of antithrombotics.