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 | Journal Scan

Study Questions:

What is the comparative efficacy of anticoagulation with bivalirudin versus heparin ± glycoprotein IIb/IIIa inhibitor (GPI) for primary percutaneous coronary intervention (PCI)?

Methods:

The authors pooled patient-level data from the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) and EUROMAX (European Ambulance Acute Coronary Syndrome Angiography) trials and compared outcomes across the two arms.

Results:

The pooled analysis was comprised of 5,800 patients, of whom 2,889 were randomized to bivalirudin and 2,911 to heparin ± GPI. The radial approach was utilized in 21.3% of patients, and GPI was used in 84.8% of the control group. Bivalirudin compared to heparin ± GPI resulted in reduced 30-day rates of major bleeding (4.2% vs. 7.8%, relative risk [RR], 0.53; 95% confidence interval [CI], 0.43-0.66; p < 0.0001), and cardiac mortality (2.0% vs. 2.9%, RR, 0.70; 95% CI, 0.50-0.97; p = 0.03), with no difference in all-cause mortality (2.4% vs. 3.1%, RR, 0.77; 95% CI, 0.57-1.05; p = 0.10). Bivalirudin was associated with increased risk of acute (<24 hour) stent thrombosis rates (1.2% vs. 0.2%, RR, 6.04; 95% CI, 2.55-14.31; p < 0.0001).

Conclusions:

The authors concluded that bivalirudin use in primary PCI was associated with less bleeding and increased risk of stent thrombosis compared with heparin and GPI among patients undergoing primary PCI.

Perspective:

This pooled analysis reconfirms what these two trials had demonstrated individually. Use of bivalirudin is associated with less bleeding and more stent thrombosis compared with routine GPI use. It appears that the relative increase in bleeding seen in association with heparin and GPI is driven by the frequency of GPI use (Cavender, Lancet 2014). Given the results of this analysis and the HEAT-PPCI trial (Shahzad, et al. Lancet 2014), the choice of anticoagulation should be tailored to the patient’s risk, with the use of GPI reserved for those at high risk of stent thrombosis and bivalirudin targeted for those at a high bleeding risk.

Clinical Topics: Anticoagulation Management, Invasive Cardiovascular Angiography and Intervention

Keywords: Heparin, Hirudins, Myocardial Infarction, Peptide Fragments, Percutaneous Coronary Intervention, Platelet Glycoprotein GPIIb-IIIa Complex, Recombinant Proteins, Risk, Stents, Thrombosis, Hemorrhage


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