ISAR-REACT 4 Shows Comparable 1-Year Outcomes for Bivalirudin Versus Abciximab With Unfractionated Heparin for NSTEMI PCI

August 23, 2013— One-year data from the ISAR-REACT 4 study of outcomes with abciximab and unfractionated heparin versus bivalirudin during percutaneous coronary interventions (PCI) in patients with non-ST-segment myocardial infarction (NSTEMI) were published by Stefani Schulz, MD, et al in EuroIntervention (2013;9:430–436). In patients with NSTEMI undergoing PCI, abciximab with heparin and bivalirudin provide comparable outcomes at 1 year, concluded the investigators.

ISAR-REACT 4 (Intracoronary Stenting and Antithrombotic Regimen–Rapid Early Action for Coronary Treatment 4) is a double-blind, randomized, active-controlled multicenter trial sponsored by the German Heart Center Munich and led by Study Chair Albert Schoemig, MD, and Principal Investigator Adnan Kastrati, MD.

In EuroIntervention, the ISAR-REACT 4 investigators advised that the background to the 1-year data is that at 30 days, the study showed no difference in ischemic complications and a reduction in bleeding by bivalirudin versus abciximab and heparin in 1,721 patients with NSTEMI undergoing PCI, but that a longer follow-up may be required to assess the whole potential benefit of a periprocedural antithrombotic therapy, noted the investigators.

As summarized in EuroIntervention, the primary outcome for this analysis was the composite of death, myocardial infarction (MI), or target vessel revascularization 1 year after randomization. The secondary outcome was the composite of death or MI.

At 1 year, the primary outcome occurred in 21.3% of patients assigned to abciximab and heparin versus 21.5% of those assigned to bivalirudin (hazard ratio [HR] 0.99; 95% confidence interval [CI], 0.80 to 1.21; P = .94). The combined incidence of death or MI was 15.7% in the abciximab and heparin group versus 16% in the bivalirudin group (HR 0.99; 95% CI, 0.78 to 1.26; P = .94). The mortality rates were 4% and 4.7%, respectively (HR 0.85; 95% CI, 0.54 to 1.34; P = .48). At 1 year, no significant differences in the primary outcome were observed with abciximab and heparin versus bivalirudin in any of the subgroups analyzed, reported the investigators in EuroIntervention.

In November 2011, bivalirudin was shown to reduce the rate of bleeding at 30 days in the ISAR-REACT 4 data simultaneously presented at the American Heart Association 2011 Scientific Sessions and published in the New England Journal of Medicine (2011;365:1980–1989).