Original title: Bivalirudin Versus Heparin With or Without Glycoprotein IIb/IIIa Inhibitors in Patients With STEMI Undergoing Primary Percutaneous Coronary Intervention: Pooled Patient-Level Analysis From the HORIZONS-AMI and EUROMAX Trials. Reference: Stone GW et al. J Am CollCardiol. 2015 Jan 6;65(1):27-38.
The HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) that included 3602 STEMI patients undergoing PCI, showed that bivalirudin had lower bleeding and mortality rates but higher acute stent thrombosis comparted to heparin combined with glycoprotein IIb/IIIa inhibitors.
Since the HORIZONS-AMI trial, PCI techniques have been enhanced with the use of more potent P2Y12 inhibitors, the radial approach and pre-hospital medication administration, included in the EUROMAX (European Ambulance Acute Coronary Syndrome Angiography, which included 2218 patients to bivalirudin vs. heparin with or without glycoprotein inhibitors before primary PCI).
Both trials randomized a total of 5800 patients to bivalirudin (n=2889) vs heparin, with or without glycoprotein inhibitors (n=2911). The radial approach was used in 21.3% of patients and the new antiaggregants (ticagrelor/prasugrel) were used in 18.1% of patients. The inhibitors were used in 84.8% of the control group.
Bivalirudin, compared to heparin with or without IIb IIIa inhibitors resulted in reduced 30 day rates of major bleeding (4.2% vs 7.8%; RR0.53; CI 95% 0.43 to 0.66; p< 0.0001), thrombocytopenia (1.4% vs 2.9%, RR 0.48; CI 95% 0.33 to 0.71; p=0.0002) and cardiac death (2.0% vs 2.9%; RR 0.70; CI 95% 0.50 to 0.97; p=0.03). There were no difference in reinfarction, ischemic driven ischemia, stroke and all-cause mortality rates.
Bivalirudin did result in increased stent thrombosis rates at 24 hours (1.2% vs 0.2%; RR 6.04; CI 95% 2.55 to 14.31; p< 0.0001) but subacute thrombosis saw no significant differences.
The composite of adverse clinical events was lower with bivalirudin (8.8% vs 11.9%; RR 0.74; CI 95% 0.63 to 0.86; p< 0.0001). There was no significant heterogeneity between the two trials endpoint outcomes, and results were consistent across all major subgroups of patients.
Conclusion
Despite an increase of acute thrombosis, PCI with bivalirudin improves net combined outcomes with significant reduction in major bleeding, thrombocytopenia and transfusions, compared to heparin with or without glycoprotein IIb/IIIa.
Editorial Comment
Radial approach and new antiaggregant rates were approximately 20%, which appears enough to change the original HORIZONS outcomes. The EUROMAX design seems to better reflect the everyday practice, with provisional use of IIb/IIIa inhibitors and frequent use of the radial access. Despite the great number of studies similar to this one, bivalirudin does not reach the everyday practice. One of the reasons behind this could be costs, but there may be other reasons for interventional cardiologists to resist incorporating this drug.
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