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

abstract

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.