Clinical study
Randomized trial of low molecular weight heparin (enoxaparin) versus unfractionated heparin for unstable coronary artery disease∗∗: One-year results of the essence study,

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Abstract

OBJECTIVES

We sought to determine whether the observed benefits of enoxaparin were maintained beyond the early phase; a one-year follow-up survey was undertaken for patients enrolled in the Efficacy and Safety of Subcutaneous Enoxaparin in Non–Q wave Coronary Events (ESSENCE) study.

BACKGROUND

We have previously reported a significant benefit of low molecular weight as compared with unfractionated heparin (UFH) in the 14- and 30-day incidence of a composite end point of death, myocardial infarction (MI) or recurrent angina in patients with unstable angina or non–Q wave MI.

METHODS

The study recruited 3,171 patients with recent-onset rest angina and underlying ischemic heart disease. All patients received oral aspirin daily and were randomized to receive enoxaparin subcutaneously every 12 h or UFH (intravenous bolus followed by continuous infusion) in a double-blind, double-dummy fashion for a median of 2.6 days.

RESULTS

The incidence of the composite triple end point at one year was lower among patients receiving enoxaparin as compared with those receiving UFH (32.0% vs. 35.7%, p = 0.022), with a trend toward a lower incidence of the secondary composite end point of death or MI (11.5% vs. 13.5%, p = 0.082). At one year, the need for diagnostic catheterization and coronary revascularization was lower in the enoxaparin group (55.8% vs. 59.4%, p = 0.036 and 35.9% vs. 41.2%, p = 0.002, respectively).

CONCLUSIONS

In patients with unstable angina or non–Q wave MI, enoxaparin therapy significantly reduced the rates of recurrent ischemic events and invasive diagnostic and therapeutic procedures in the short term with sustained benefit at one year.

Abbreviations

CI
confidence interval
CK
creatine kinase
ECG
electrocardiographic
ESSENCE
Efficacy and Safety of Subcutaneous Enoxaparin in Non–Q wave Coronary Events
LMWH
low molecular weight heparin
MI
myocardial infarction
OR
odds ratio
PCI
percutaneous coronary intervention
UFH
unfractionated heparin

Cited by (0)

This study was supported by the Rhone-Poulenc Rorer Corporation, Antony, France and Collegeville, Pennsylvania.

∗∗

A list of participating ESSENCE Study Group investigators may be found in N Engl J Med 1997;337:447–52.