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EUROMAX: Bivalirudin superior to heparin in pre-hospital setting for patients with STEMI
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SAN FRANCISCO — Giving patients with STEMI the anticoagulant bivalirudin in a pre-hospital setting produced better outcomes than with heparin administration, according to findings presented at TCT 2013.
P. Gabriel Steg, MD, of Hôpital Bichat, Paris, presented findings from the EUROMAX trial indicating that patients with STEMI in need of primary PCI who were infused with bivalirudin (Angiox, The Medicines Company) in an ambulance or a non-PCI-capable hospital had better 30-day outcomes related to death, reinfarction and bleeding compared with those infused with heparin with or without glycoprotein IIb/IIIa inhibitors. However, patients assigned bivalirudin had a higher rate of stent thrombosis than those assigned heparin.
P. Gabriel Steg
Although the HORIZONS-AMI trial established the safety and efficacy of bivalirudin, researchers wanted to further explore issues raised in that trial, Steg said during a press conference. Specific issues included “the role of bivalirudin in the ambulance for primary PCI” and “the impact of contemporary practice, [such as] the use of novel P2Y12 inhibitors, increased use of radial arterial access, and the lack of systematic use of [glycoprotein IIb/IIIa inhibitors] in clinical practice on the ratio of efficacy and safety with bivalirudin.”
Patients with STEMI (n=2,218) were randomized in an ambulance or non-PCI-capable hospital to receive either bivalirudin (n=1,089) or heparin with or without glycoprotein IIb/IIIa inhibitors depending on established local practice. The primary outcome was a composite of death and non–CABG-related major bleeding at 30 days and the key secondary outcome was a composite of death, recurrence of MI and non-CABG-related major bleeding at 30 days, Steg said.
Patients assigned bivalirudin had a 40% relative risk reduction in the primary outcome (5.1% vs. 8.4%; P=.002) and a 28% relative risk reduction in the key secondary outcome (6.7% vs. 9.1%; P=.03) compared with those assigned heparin.
“This was largely driven by a large reduction in non-CABG major bleeding,” Steg said. Bivalirudin was associated with a 57% relative risk reduction in non-CABG major bleeding compared with heparin (2.7% vs. 6.1%; P=.002).
Stent thrombosis occurred more often in the bivalirudin group than the heparin group (1.6% vs. 0.5%; RR=2.89; 95% CI, 1.14-7.29), primarily because of a difference in acute stent thrombosis, Steg said. However, he said, that did not produce a difference between groups in the composite of reinfarction, ischemia-driven revascularization or stent thrombosis (2.7% vs. 1.9%; RR=1.41; 95% CI, 0.81-2.45).
For more information:
Steg PG. Plenary Session VII: Late Breaking Clinical Trials II. Presented at: TCT 2013; Oct. 27-Nov. 1, 2013; San Francisco.
Disclosure: The study was funded by The Medicines Company. Steg is a speaker and consultant for The Medicines Company and reports financial ties to several other device and pharmaceutical companies.
Perspective
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Barry Cohen, MD
The EUROMAX study using pre-hospital bivalirudin in STEMI patients demonstrated a significantly lower rate of bleeding driving the composite of death, reinfarction and major non–CABG-related bleeding when compared with unfractionated heparin with or without GIIb/IIIa inhibitors. The authors correctly highlight whether the radial access will negate the benefit and the concern of higher stent thrombosis in the bivalirudin cohort. Perhaps newer antiplatelet agents will decrease the stent thrombosis; however, a randomized clinical trial will be required to answer that question.
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