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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

Shaun G. Goodman, MD, FACC^a, Marc Cohen, MD, FACC^*, Frederique Bigonzi, MD, Enrique P. Gurfinkel, MD, David R. Radley, MSc, Veronique Le Iouer, MS^d, Gregg J. Fromell, MD, Christine Demers, MD, Alexander G. G. Turpie, MD^||, Robert M. Califf, MD, FACC^¶, Keith A. A. Fox, MD^#, Anatoly Langer, MD, FACC for the Efficacy and Safety of Subcutaneous Enoxaparin in Non–Q Wave Coronary Events (ESSENCE) Study Group^**

^a Canadian Heart Research Center, Division of Cardiology, St. Michael’s Hospital, University of Toronto, Toronto, Canada
^* Division of Cardiology, Allegheny University Hospitals, Hahnemann Division, Philadelphia, Pennsylvania, USA
Rhone-Poulenc Rorer Corp., Antony, France
^d Rhone-Poulenc Rorer Corp., Collegeville, Pennsylvania, USA
Institute of Cardiology, Favaloro Foundation, Buenos Aires, Argentina
Hopital St. Sacrement, Quebec, Canada
^|| McMaster University, Hamilton, Canada
^¶ Duke University, Durham, North Carolina, USA
^# Royal Infirmary, Edinburgh, United Kingdom

Manuscript received October 20, 1999; revised manuscript received February 22, 2000, accepted April 11, 2000.

Reprint requests and correspondence: Dr. Shaun G. Goodman, St. Michael’s Hospital, Division of Cardiology, 30 Bond Street, Room 9-005 Queen, Toronto, Ontario, Canada M5B 1W8
goodmans{at}smh.toronto.on.ca

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 and Acronyms   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

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