November 1, 1996Circulation
Effects of Integrelin, a Platelet Glycoprotein IIb/IIIa Receptor Antagonist, in Unstable Angina
Key result
High-dose IV Integrelin cuts Holter ischemic episodes ~76% and shortens duration vs aspirin.
- P<.05
- n=227
Why the study?
Does eptifibatide reduce the frequency and duration of Holter ischemia in patients with unstable angina compared to aspirin?
Population
227 patients with unstable angina
Comparison
Eptifibatide and placebo aspirin, added to… vs Oral aspirin and placebo eptifibatide, added to…
Design
RCT, randomized, placebo-controlled (placebo aspirin and placebo eptifibatide)
Follow-up
24 to 72 hours
Authors
Discussion
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Implication
Supports eptifibatide over aspirin to curb ischemia in unstable angina; extends evidence for potent platelet inhibition in ACS.
Key Points
- The aim is to evaluate the effect of Integrelin on the frequency and duration of ischemic episodes in patients with unstable angina.
- 227 patients were randomized to receive either oral aspirin with placebo Integrelin or varying doses of Integrelin with placebo aspirin.
- Patients underwent Holter monitoring for ischemic events for 24 to 72 hours.
- Platelet aggregation was measured in a subset of patients.
- High-dose Integrelin group had 0.24 ischemic episodes lasting 8.41 minutes, compared to the aspirin group with 1.0 episodes lasting 26.2 minutes (P < .05).
- There was no rebound ischemia after withdrawal of Integrelin.
- Integrelin rapidly inhibited platelet aggregation in a dose-dependent manner without significant bleeding differences between groups.
Study Design
Type
RCT (n=227)
Blinding
Placebo-controlled
Randomization
Randomized
Structured PICO
Does eptifibatide reduce the frequency and duration of Holter ischemia in patients with unstable angina compared to aspirin?
P
Population
227 patients with unstable angina receiving intravenous heparin and standard ischemic therapy, monitored with Holter for 24 to 72 hours.
I
Intervention
Eptifibatide (low-dose: 45 mcg/kg bolus followed by 0.5 mcg/kg/min continuous infusion; or high-dose: 90 mcg/kg bolus followed by 1.0 mcg/kg/min constant infusion) and placebo aspirin, added to intravenous heparin and standard ischemic therapy for 24 to 72 hours
C
Comparator
Oral aspirin and placebo eptifibatide, added to intravenous heparin and standard ischemic therapy
O
Outcome
Frequency and duration of Holter ischemia over 24 hours of study drug infusionsurrogate
Main Result
Absolute Event Rate: 0.24% vs 1%
p-value: p=< .05
Intravenous eptifibatide added to heparin significantly reduces the number and duration of ischemic events in unstable angina compared to aspirin.
Limitations
- The number of clinical events was small
Cite This Study
Schulman et al. (1996) conducted an RCT in Unstable angina (n=227). Integrelin (high-dose) vs. Aspirin was evaluated on Frequency of Holter ischemia over 24 hours (number of ischemic episodes) (p=< .05). High-dose intravenous Integrelin significantly reduced the number (0.24 vs 1.0 episodes, P<0.05) and duration (8.41 vs 26.2 minutes, P=0.01) of Holter ischemic events compared with aspirin.