Key result
Abciximab cuts 1-year death, MI, or urgent revascularization by ~40% versus placebo.
Why the study?
Does abciximab reduce the composite of death, myocardial infarction, or urgent repeat revascularization in patients undergoing percutaneous coronary revascularization?
RCT (n=2,792)
Double-blind
randomized
Does abciximab reduce the composite of death, myocardial infarction, or urgent repeat revascularization in patients undergoing percutaneous coronary revascularization?
Abciximab significantly reduces the 1-year incidence of death, myocardial infarction, or urgent repeat revascularization in patients undergoing percutaneous coronary intervention.
Answers are grounded in this paper and cite their sources.
Abciximab during PCI cuts 1-year ischemic events; extends 30-day benefits to sustained outcomes.
BACKGROUND: Blockade of the platelet glycoprotein IIb/IIIa receptor with the monoclonal antibody fragment abciximab was shown in a placebo-controlled randomized trial to reduce the incidence of acute ischemic complications within 30 days among a broad spectrum of patients undergoing percutaneous coronary revascularization. The durability of clinical benefit in this setting has not been established. METHODS AND RESULTS: A total of 2792 patients enrolled in the Evaluation in PTCA to Improve Long-term Outcome with abciximab GP IIb/IIIa blockade (EPILOG) trial were followed with maintenance of double-blinding for 1 year. Patients had been assigned at the time of their index coronary interventional procedure to receive placebo with standard-dose, weight-adjusted heparin (100 U/kg initial bolus), abciximab with standard-dose, weight-adjusted heparin, or abciximab with low-dose, weight-adjusted heparin (70 U/kg initial bolus). The primary outcome was the composite of death, myocardial infarction, or urgent repeat revascularization by 30 days; this composite end point and its individual components were also assessed at 6 months and 1 year. Rates of any repeat revascularization (urgent or elective), target vessel revascularization, and a composite of death, myocardial infarction, or any repeat revascularization were also reported. Follow-up at 1 year was 99% complete for survival status and 97% complete for other end points. By 1 year, the incidence of the primary composite end point was 16.1% in the placebo group, 9.6% in the abciximab with low-dose heparin group (P<0.001), and 9.5% in the abciximab with standard-dose heparin group (P<0.001). Each of the components of this composite end point was reduced to a similar extent. Nonurgent or target vessel repeat revascularization rates were not significantly decreased by abciximab therapy. Mortality rates over 1 year increased with increasing levels of periprocedural creatine kinase MB fraction elevation. CONCLUSIONS: Acute reductions in ischemic events after percutaneous coronary intervention by abciximab are sustained over follow-up to at least 1 year. Early periprocedural myocardial infarctions suppressed by this therapy are associated with long-term mortality rates.
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Lincoff et al. (1999) conducted an RCT in percutaneous coronary revascularization (n=2,792). abciximab vs. placebo with standard-dose heparin (100 U/kg) was evaluated on composite of death, myocardial infarction, or urgent repeat revascularization at 1 year (p=<0.001). Abciximab with low- or standard-dose heparin reduced the 1-year composite of death, MI, or urgent repeat revascularization compared to placebo (9.6% and 9.5% vs 16.1%; P<0.001).
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