Prof. Franz Josef Neumann,
Prof. Julinda Mehilli,
Dr. Adnan Kastrati,
Presenter report: Seyfarth, Melchior (Germany) View the slides
It has been demonstrated that abciximab reduces the 30-day incidence of adverse events in high-risk patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) undergoing percutaneous coronary intervention (PCI) after pretreatment with 600 mg of clopidogrel. We performed this analysis to determine whether the benefit is sustained at 1 year.
We performed one-year follow-up of 2022 patients with NSTE-ACS undergoing urgent PCI who were randomized to abciximab or placebo after pretreatment with 600 mg of clopidogrel in the ISAR-REACT 2 trial. The combined incidence of death, myocardial infarction and target vessel revascularization at 1 year was the primary end point. At 1 year the primary end point was reached in 23.3% of the abciximab group versus 28.0% of the placebo group (relative risk [RR]: 0.80, 95% confidence interval [CI] 0.67-0.95; P=0.012). The combined incidence of death or myocardial infarction was 11.6% among patients treated with abciximab versus 15.3% among patients treated with placebo (RR 0.74, 95% CI 0.59-0.94, P=0.015). Abciximab reduced the incidence of the primary end point in patients with an elevated troponin (28.6% vs. 33.3%; RR 0.82, 95% CI 0.66-1.02) and in patients without an elevated troponin (17.8% vs. 22.0%; RR 0.79, 95% CI 0.59-1.05).
In high-risk patients with non-ST-segment elevation acute coronary syndromes undergoing a percutaneous coronary intervention after pretreatment with 600 mg of clopidogrel, adverse events occurred less frequently with abciximab and the early benefit was maintained at 1 year after administration. Another novel finding of this 1-year analysis is the additional benefit of Abciximab in low-risk patients without an elevated troponin in terms of a reduction of target vessel revascularization.
The current study support the finding that the benefit of abciximab in patients with non-ST-segment elevation acute coronary syndrome undergoing PCI is sustainable at one year. The results of subgroup analyses, however, should be interpreted with caution because they are subject to the influence of limited power and multiple testing. Obviously, they need confirmation from specifically designed studies in the future.
Clinical Trial Update I
Discussant : Fox, Keith (United Kingdom)
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