AIMS: Thirty-day results of the double-blind, randomised Intracoronary Stenting and Antithrombotic Regimen -Rapid Early Action for Coronary Treatment (ISAR-REACT) 4 trial showed no difference in ischaemic complications and a reduction in bleeding by bivalirudin versus abciximab and heparin in 1,721 patients with non-ST-segment elevation myocardial infarction (NSTEMI) undergoing percutaneous coronary intervention (PCI). A longer follow-up may be required to assess the whole potential benefit of a periprocedural antithrombotic therapy. METHODS AND RESULTS: The primary outcome for this analysis was the composite of death, myocardial infarction or target vessel revascularisation one year after randomisation. Secondary outcome was the composite of death or myocardial infarction. At one year, the primary outcome occurred in 21.3% of patients assigned to abciximab and heparin versus 21.5% assigned to bivalirudin (hazard ratio [HR] 0.99; 95% confidence interval [CI]: 0.80-1.21; p=0.94). The combined incidence of death or myocardial infarction was 15.7% in the abciximab and heparin group versus 16.0% in the bivalirudin group (HR 0.99; 95% CI: 0.78-1.26; p=0.94). The mortality rates were 4.0% and 4.7%, respectively (HR 0.85; 95% CI: 0.54-1.34; p=0.48). At one year, no significant differences in the primary outcome were observed with abciximab and heparin versus bivalirudin in any of the subgroups analysed. CONCLUSIONS: In patients with NSTEMI undergoing PCI, abciximab with heparin and bivalirudin provide comparable outcomes at one year, although bivalirudin reduced the rate of bleeding at 30 days. CLINICAL TRIAL REGISTRATION INFORMATION: URL www.clinicaltrials.gov; Unique identifier NCT00373451.
RCT Entities:
AIMS: Thirty-day results of the double-blind, randomised Intracoronary Stenting and Antithrombotic Regimen -Rapid Early Action for Coronary Treatment (ISAR-REACT) 4 trial showed no difference in ischaemic complications and a reduction in bleeding by bivalirudin versus abciximab and heparin in 1,721 patients with non-ST-segment elevation myocardial infarction (NSTEMI) undergoing percutaneous coronary intervention (PCI). A longer follow-up may be required to assess the whole potential benefit of a periprocedural antithrombotic therapy. METHODS AND RESULTS: The primary outcome for this analysis was the composite of death, myocardial infarction or target vessel revascularisation one year after randomisation. Secondary outcome was the composite of death or myocardial infarction. At one year, the primary outcome occurred in 21.3% of patients assigned to abciximab and heparin versus 21.5% assigned to bivalirudin (hazard ratio [HR] 0.99; 95% confidence interval [CI]: 0.80-1.21; p=0.94). The combined incidence of death or myocardial infarction was 15.7% in the abciximab and heparin group versus 16.0% in the bivalirudin group (HR 0.99; 95% CI: 0.78-1.26; p=0.94). The mortality rates were 4.0% and 4.7%, respectively (HR 0.85; 95% CI: 0.54-1.34; p=0.48). At one year, no significant differences in the primary outcome were observed with abciximab and heparin versus bivalirudin in any of the subgroups analysed. CONCLUSIONS: In patients with NSTEMI undergoing PCI, abciximab with heparin and bivalirudin provide comparable outcomes at one year, although bivalirudin reduced the rate of bleeding at 30 days. CLINICAL TRIAL REGISTRATION INFORMATION: URL www.clinicaltrials.gov; Unique identifier NCT00373451.