ESSENCE
Trial question
Is enoxaparin superior to UFH in patients with angina at rest or non-Q-wave MI receiving aspirin?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 3171
3171 patients (1059 female, 2112 male).
Inclusion criteria: patients with angina at rest or non-Q-wave myocardial infarctio receiving aspirin.
Key exclusion criteria: left bundle-branch block or pacemaker, persistent ST-segment elevation, angina with HF or tachydysrhythmia, contraindications to anticoagulation, or a CrCl rate < 30 ml/min.
Interventions
N=1607 enoxaparin (1 mg/kg of body weight SC BID for a minimum of 48 hours to maximum of 8 days).
N=1564 UFH (continuous intravenous UFH for a minimum of 48 hours to maximum of 8 days).
Primary outcome
Death, MI, or recurrent angina at 14 days
16.6%
19.8%
19.8 %
14.9 %
9.9 %
5.0 %
0.0 %
Enoxaparin
Unfractionated
heparin
Significant
decrease ▼
NNT = 31
Significant decrease in death, MI, or recurrent angina at 14 days (16.6% vs. 19.8%; OR 0.8, 95% CI 0.67 to 0.96).
Secondary outcomes
Significant increase in need for revascularization at 30 days (27.1% vs. 32.2%; RR 16, 95% CI 6.51 to 25.49).
Safety outcomes
No significant difference in major bleeding at 30 days (6.5% vs. 7.0%).
Significant differences in overall bleeding (18.4% vs. 14.2%, p = 0.001).
Conclusion
In patients with angina at rest or non-Q-wave myocardial infarctio receiving aspirin, enoxaparin was superior to UFH with respect to death, MI, or recurrent angina at 14 days.
Reference
Cohen M, Demers C, Gurfinkel EP et al. A comparison of low-molecular-weight heparin with unfractionated heparin for unstable coronary artery disease. Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events Study Group. N Engl J Med. 1997 Aug 14;337(7):447-52.
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