One year outcomes with abciximab vs. placebo during percutaneous coronary intervention after pre-treatment with clopidogrel†

Abstract

In the Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment Trial, the use of abciximab in patients undergoing percutaneous coronary intervention (PCI) after pretreatment with 600 mg clopidogrel for >2 h was associated with no clinically measurable benefit at 30 days. We assessed whether there was any clinical benefit from abciximab at 1 year follow-up. After pre-treatment with 600 mg clopidogrel, a total of 2159 patients undergoing PCI for stable or unstable angina without marked ST-segment shifts or positive biomarkers were randomly assigned to receive abciximab or placebo. The occurrence of the composite endpoint of death, myocardial infarction, or target vessel revascularization was assessed at 1 year after randomization. At 1 year, the composite endpoint occurred in 23.8% of the patients in each group [relative risk (RR), 1.01; 95% confidence interval (CI), 0.85-1.20; P=0.92]. The combined incidence of death and myocardial infarction was 6.0% in the abciximab group and 6.4% in the placebo group (RR, 0.94; 95% CI, 0.67-1.32; P=0.73). The mortality rate was 2.1% in the abciximab group and 2.4% in the placebo group (RR, 0.88; 95% CI, 0.50-1.54; P=0.66). No trend towards clinical benefit was observed with abciximab at 1 year in any subgroup analysed. In patients with a low-to-intermediate risk profile undergoing PCI after pre-treatment with a 600 mg clopidogrel for at least 2 h, the use of abciximab offers no additional clinical benefit at 1 year.