ESSENCE

Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events (1997)

Condition

Treatment of unstable coronary artery disease

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Objective

To evaluate the efficacy of enoxaparin vs. UFH, plus ASA, in patients with unstable angina or non-Q-wave infarction

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Trial design

Randomized, double-blind, placebo-controlled study
Active treatment: enoxaparin 1 mg/kg s.c. twice daily; UFH placebo (n=1607)
Control treatment: UFH i.v. bolus of 5000 IU followed by a continuous infusion to target an aPTT of 55–85 seconds; enoxaparin placebo (n=1564)

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Endpoints

Primary efficacy endpoint: composite of death, myocardial infarction (or reinfarction), or recurrent angina at 14 days of follow-up
Secondary efficacy endpoints: triple composite endpoint at 48 hours and at 30 days; composite of death or myocardial infarction at 48 hours, 14 days, and 30 days
Safety endpoint: major and minor hemorrhage

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Trial participants

3171 patients (mean age 63.5 years) with recent onset of angina at rest lasting at least 10 minutes or non-Q-wave myocardial infarction

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Results

Efficacy outcome: The incidence of the composite triple endpoint (death, myocardial infarction, or recurrent angina) was significantly lower in the enoxaparin group than in the UFH group at 14 days (16.6% vs. 19.8%, relative risk reduction 16.2%) and at 30 days (19.8% vs. 23.3%, relative risk reduction 15.0%). The secondary composite endpoint of death or myocardial infarction was reached at 14 days in 4.9% of the enoxaparin treated patients as compared with 6.1% of the UFH treated patients (relative risk reduction 19.9%) and at 30 days in 6.2% of the enoxaparin group vs. 7.7% of the UFH group (relative risk reduction 20.4%). The need for revascularization at 30 days was significantly lower in the enoxaparin group than in the UFH group (27.0% vs. 32.2%; relative risk reduction 16.0%)
Safety outcome: Hemorrhagic complications occurred more frequently in patients treated with enoxaparin than among those treated with UFH: 9.4% vs. 4.4% while patients were receiving the study medication and 18.4% vs. 14.2% 30 days after randomization

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Summary

Efficacy: Antithrombotic treatment with enoxaparin was significantly more effective than UFH in preventing death, myocardial infarction, or recurrent angina in patients with unstable angina or non-Q-wave infarction. The benefit at 14 days was sustained through 30 days of follow-up
Safety: There was a significant increase in minor bleeding with enoxaparin but not in serious hemorrhagic complications

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Reference

Cohen M, Demers C, Gurfinkel EP, Turpie AG, Fromell GJ, Goodman S, Langer A, Califf RM, Fox KA, Premmereur J, Bigonzi F, for the Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events Study Group. A comparison of low-molecular-weight heparin with unfractionated heparin for unstable coronary artery disease. N Engl J Med 1997;337:447-452

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Corresponding author

Marc Cohen, MD, Division of Cardiology, MCP-Hahnemann School of Medicine, Allegheny University of the Health Sciences, Mail Stop-119, Philadelphia, PA 19102

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