Analysis Favors Bivalirudin in STEMI Patients Undergoing Primary PCI

January 6, 2015—In the Journal of the American College of Cardiology, Gregg W. Stone, MD, et al published findings from a study that sought to examine the outcomes of procedural anticoagulation with bivalirudin versus heparin with or without glycoprotein IIb/IIIa inhibitor (GPI) for primary percutaneous coronary intervention (PCI), given the evolution in primary PCI (2015;65:27–38).

The investigators conducted a pooled patient-level analysis of databases from the HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) and EUROMAX (European Ambulance Acute Coronary Syndrome Angiography) trials. The Breslow-Day test evaluated heterogeneity between trials.

In the HORIZONS-AMI trial, 3,602 patients undergoing primary PCI for ST-segment elevation myocardial infarction (STEMI) treated with bivalirudin had lower bleeding and mortality rates but higher acute stent thrombosis rates compared with heparin with GPI. Subsequent changes in primary PCI, including the use of potent P2Y12 inhibitors, frequent radial intervention, and prehospital medication administration, were incorporated into the EUROMAX trial, which assigned 2,218 patients to bivalirudin versus heparin with or without GPI before primary PCI.

As summarized in Journal of the American College of Cardiology, a total of 5,800 patients were randomized to bivalirudin (n = 2,889) or heparin with or without GPI (n = 2,911). The radial approach was used in 21.3% of patients, prasugrel/ticagrelor was used in 18.1% of patients, and GPI was used in 84.8% of the control group.

The investigators reported that bivalirudin compared with heparin with or without GPI resulted in reduced 30-day rates of major bleeding (4.2% vs 7.8%), thrombocytopenia (1.4% vs 2.9%), and cardiac mortality (2% vs 2.9%), with nonsignificantly different rates of reinfarction, ischemia-driven revascularization, stroke, and all-cause mortality. Bivalirudin resulted in increased acute stent thrombosis rates, with nonsignificantly different rates of subacute stent thrombosis. Composite net adverse clinical events were lower with bivalirudin (8.8% vs 11.9%). There was no significant heterogeneity between the two trials for these outcomes, and results were consistent across major subgroups.

The investigator concluded that despite increased acute stent thrombosis, primary PCI with bivalirudin improved 30-day net clinical outcomes, with significant reductions in major bleeding, thrombocytopenia, and transfusions compared with heparin with or without GPI, results that were consistent with evolution in PCI technique and pharmacotherapy, concluded the investigators in Journal of the American College of Cardiology.