ESSENCE trial results: breaking new ground. Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q wave Coronary Events.

OBJECTIVE

To demonstrate the superiority of enoxaparin compared with unfractionated heparin (UFH) in preventing recurrent angina, myocardial infarction (MI) and death in patients presenting with unstable angina or non-Q wave MI.

DESIGN

A prospective, randomized, double-blind multicentre trial.

SETTING

One hundred and seventy-six centers in 10 countries.

PATIENTS

Three thousand one hundred and seventy-one patients, male or nonpregnant females, 18 years of age or older, with unstable angina or non-Q wave MI.

INTERVENTION

Patients received either enoxaparin 1 mg/kg every 12 h subcutaneously plus an intravenous placebo, or subcutaneous placebo injections and UFH as a continuous intravenous infusion. All patients received 100 mg to 325 mg of acetylsalicylic acid daily. Study treatment was administered for 48 h to 8 days.

MAIN RESULTS

The primary end-point (recurrent angina, MI or death) was significantly lower in the enoxaparin group compared with the UFH group (16.6% versus 19.8%; P = 0.02) after 14 days and remained significant after 30 days. The need for coronary revascularization was significantly lower for patients assigned to enoxaparin (27.0% versus 32.2%; P < 0.01) after 30 days. There was no difference in the risk of serious hemorrhage between the two groups, but there was a significantly higher incidence of minor hemorrhagic complications in the enoxaparin group (11.9%) versus 7.2%; P < 0.01).

CONCLUSIONS

Enoxaparin significantly reduced the triple end-point of recurrent angina, MI and death at 14 days, with a sustained effect at 30 days. There was no increase in the total number of hemorrhages; however, a significant increase in the rate of minor hemorrhage was observed.