August 1, 2007EuroIntervention
A randomised controlled trial of upstream administration of eptifibatide in patients presenting non-ST segment elevation acute coronary syndrome treated with an invasive strategy
Key result
Upstream eptifibatide did not significantly reduce the 30-day composite of death, MI, or urgent revascularisation compared to placebo in NSTEACS patients (OR 0.93; 95% CI 0.53-1.53; P=0.70).
Why the study?
Does upstream administration of eptifibatide reduce the composite of death, myocardial infarction, or urgent revascularisation at 30 days in patients with NSTEACS pretreated with aspirin and clopidogrel undergoing an invasive strategy?
Population
393 patients presenting with non ST-segment elevation acute coronary syndrome planned for an invasive…
Comparison
Upstream administration of eptifibatide added to… vs Double-blind placebo added to aspirin…
Design
RCT, randomly assigned, double-blind
Follow-up
30 days
Authors
Discussion
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Implication
Upstream eptifibatide confers no 30-day benefit in pretreated NSTEACS; challenges routine upstream GP IIb/IIIa use before invasive strategy.
Study Design
Type
RCT (n=393)
Blinding
Double-blind
Randomization
randomly assigned
Multicenter
Yes
Structured PICO
Does upstream administration of eptifibatide reduce the composite of death, myocardial infarction, or urgent revascularisation at 30 days in patients with NSTEACS pretreated with aspirin and clopidogrel undergoing an invasive strategy?
P
Population
393 patients presenting with NSTEACS pretreated with aspirin and clopidogrel, managed with an invasive strategy, followed for 30 days.
I
Intervention
Upstream administration of eptifibatide added to aspirin, clopidogrel (300 mg loading dose followed by 75 mg daily), and heparin (unfractionated or low molecular weight).
C
Comparator
Double-blind placebo added to aspirin, clopidogrel (300 mg loading dose followed by 75 mg daily), and heparin (unfractionated or low molecular weight).
O
Outcome
Composite of death, myocardial infarction, or urgent revascularisation at 30 dayscomposite
Main Result
Odds Ratio: 0.93 (95% CI 0.53–1.53)
Absolute Event Rate: 15.8% vs 16.8%
p-value: p=0.70
Upstream administration of eptifibatide did not provide measurable clinical benefit over placebo in NSTEACS patients pretreated with aspirin and clopidogrel undergoing an invasive strategy.
Limitations
- Enrolled only 393 of 766 planned patients, suggesting the study may be underpowered
- Underpowered due to early termination (enrolled 393 of 766 planned patients)
Cite This Study
Durand et al. (2007) conducted an RCT in non-ST segment elevation acute coronary syndrome (NSTEACS) (n=393). eptifibatide vs. placebo was evaluated on composite of death, myocardial infarction, or urgent revascularisation at 30 days (OR 0.93, 95% CI 0.53 to 1.53, p=0.70). Upstream eptifibatide did not significantly reduce the 30-day composite of death, MI, or urgent revascularisation compared to placebo in NSTEACS patients (OR 0.93; 95% CI 0.53-1.53; P=0.70).