Randomized trial of low molecular weight heparin (enoxaparin) versus unfractionated heparin for unstable coronary artery disease: one-year results of the ESSENCE Study. Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q Wave Coronary Events.
OBJECTIVE
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-Qwave 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-Qwave 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.
Goodman
S G
SG
Canadian Heart Research Center, Division of Cardiology, St. Michael's Hospital, University of Toronto, Ontario, Canada. goodmans@smh.toronto.on.ca
Cohen
M
M
Bigonzi
F
F
Gurfinkel
E P
EP
Radley
D R
DR
Le Iouer
V
V
Fromell
G J
GJ
Demers
C
C
Turpie
A G
AG
Califf
R M
RM
Fox
K A
KA
Langer
A
A
D000328:Adult; D000368:Aged; D000789:Angina, Unstable / Q000150:complications / Q000188:drug therapy*; D006328:Cardiac Catheterization / Q000706:statistics & numerical data; D004311:Double-Blind Method; D017984:Enoxaparin / Q000627:therapeutic use*; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006493:Heparin / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000453:epidemiology / Q000209:etiology / Q000401:mortality; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D055502:Secondary Prevention
D017984:Enoxaparin; D005343:Fibrinolytic Agents; D006493:Heparin