January 28, 2003Open Access
View Full PaperLong-Term Results After the Glycoprotein IIb/IIIa Inhibitor Abciximab in Unstable Angina
Key Result
Abciximab did not improve 1-year mortality compared with placebo in patients with non-ST-elevation acute coronary syndrome (8.2% vs 7.8%; HR 1.1, 95% CI 0.86-1.29 for 24-hour infusion).
Study Design
Type
RCT (n=7,800)
Blinding
Placebo-controlled
Randomization
Randomized
Structured PICO
Does abciximab reduce 1-year mortality in patients with NSTE-ACS who are not scheduled for early coronary intervention?
P
Population
7,800 patients with acute coronary syndrome without ST elevation who were not scheduled for coronary intervention, followed for 1 year.
I
Intervention
Abciximab bolus followed by either a 24-hour infusion or a 48-hour infusion.
C
Comparator
Matching placebo.
O
Outcome
1-year mortality.hard clinical
In patients with NSTE-ACS managed medically without early revascularization, abciximab does not improve 1-year survival and is associated with excess mortality in subgroups with negative troponin or elevated CRP.
Main Result
Hazard Ratio: 1.1 (95% CI 0.86–1.29)
Absolute Event Rate: 8.2% vs 7.8%
Abstract
BACKGROUND: This study was designed to investigate long-term effects of the glycoprotein IIb/IIIa inhibitor abciximab in patients with acute coronary syndrome without ST elevation who were not scheduled for coronary intervention. METHODS AND RESULTS: A total of 7800 patients were included with an acute coronary syndrome without ST elevation, documented by either elevated cardiac troponin or transient or persistent ST-segment depression. They were randomized to abciximab bolus and 24-hour infusion, abciximab bolus and 48-hour infusion, or matching placebo. The overall 1-year mortality rate was 8.3% (649 patients). One-year mortality was 7.8% in the placebo group and 8.2% in the 24-hour and 9.0% in the 48-hour abciximab infusion group. Compared with placebo, the hazard ratio for the 24-hour infusion of abciximab was 1.1 (95% CI 0.86 to 1.29), and for the 48-hour infusion, it was 1.2 (95% CI 0.95 to 1.41). The lack of benefit of abciximab was observed in every subgroup studied. Patients with negative troponin or elevated C-reactive protein had a higher mortality rate after treatment with abciximab for 48 hours than with placebo: 8.5% versus 5.8% in those with negative troponin (P=0.02), 16.3% versus 12.1% in those with elevated C-reactive protein (P=0.04). CONCLUSIONS: Compared with placebo, abciximab did not provide any survival benefit at 1 year in patients admitted with an acute coronary syndrome with ST depression and/or elevated troponin who were not scheduled to undergo early coronary revascularization. In subgroups of patients, in particular those with low cardiac troponin or elevated C-reactive protein, abciximab was associated with excess mortality.