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EUROMAX substudy: Bivalirudin bests 2 heparin, GPI strategies
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PARIS — Routine upstream treatment with bivalirudin reduced the combined endpoint of death and major bleeding when compared with heparin plus routine glycoprotein IIb/IIIa inhibition and heparin only plus bailout glycoprotein IIb/IIIa inhibition, according to a substudy of the EUROMAX trial.
Uwe Zeymer, MD, of the Institut für Herzinfarktforschung Ludwigshafen, Germany, and investigator of the EUROMAX trial, presented the study at EuroPCR and said that although the HORIZONS-AMI trial demonstrated reductions of mortality and bleeding with in-hospital treatment of bivalirudin (Angiomax, The Medicines Company), there was some criticism of the trial because today not everyone is using glycoprotein IIb/IIIa inhibitors (GPI) with primary PCI. “Therefore, it’s unknown if this advantage of bivalirudin is seen in comparison with heparin only plus the strategy of bailout GPI,” he said.
This led Zeymer and colleagues to perform an analysis of the EUROMAX trial, which included 2,198 patients who were randomly assigned 1:1 to either heparin with or without GPI (n=1,109) or bivalirudin with provisional GPI only (n=1,089). Overall, 58.5% of patients in the heparin arm received routine GPI and 41.5% received no GPI, 25.4% of whom were treated with bailout GPI.
According to results, the primary endpoint — defined as death or major bleeding— was significantly lower in the bivalirudin group compared with the routine GPI (5.1% vs. 7.4%; P=.0425) and the bailout GPI (5.1% vs. 9.8%; P=.0006) groups.
Additional analysis showed that compared with the heparin plus bailout GPI group, those who received bivalirudin experienced reductions in the secondary endpoint of death, MI or major bleeding (P=.01), as well as major bleeding (P<.001) and the combined endpoint of death, MI, ischemia-driven revascularization, stroke or major bleeding (P=.006).
The endpoints of all-cause death, cardiac death, MACE, reinfarction and stent thrombosis were not significantly different between the bivalirudin and the heparin plus bailout GPI group. – by Brian Ellis
For more information:
Zeymer U. Hot line: Adjunctive pharmacology. Presented at: EuroPCR; May 20-23, 2014; Paris.
Disclosure: Zeymer reports receiving honoraria from The Medicines Company.
Perspective
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Dominick J. Angiolillo, MD, PhD
We have very consistent data coming from the EUROMAX and HORIZONS-AMI trials, but we also have conflicting findings from the HEAT-PPCI trial presented at the American College of Cardiology Scientific Sessions this year by our colleagues in Liverpool. There are significant differences in trial design — such as HEAT-PPCI being a single-center study — that can contribute to these findings. The HEAT-PPCI trial does have its merits because it was a very large study performed in an all-comer patient population in which antithrombotic treatment regimens commonly utilized by the investigators in their practice were considered for the randomized comparison. In both arms there was a bailout strategy of glycoprotein IIb/IIIa use and the investigators were unable to confirm a benefit of bivalirudin vs. heparin, as there was a lower risk of ischemic events in the heparin arm with no differences in bleeding. These are data that need to be further digested. But this analysis of the EUROMAX trial does continue to support the role of bivalirudin in primary PCI.
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