Oral rivaroxaban noninferior to subcutaneous enoxaparin for acute coronary syndrome

In the treatment of patients with acute coronary syndrome (ACS) receiving dual antiplatelet therapy (DAPT) during the acute phase, oral rivaroxaban appears to compare favourably with subcutaneous enoxaparin in terms of bleeding and major adverse cardiovascular event (MACE) risks, according to a study.

The study included 2,055 ACS patients who missed the primary reperfusion window or before selective revascularization. They were randomized to receive treatment with oral rivaroxaban at 2.5 or 5 mg or subcutaneous enoxaparin 1 mg/kg twice daily in addition to DAPT (aspirin 100 mg and clopidogrel 75 mg once daily) for a mean of 3.7 days.

The primary safety outcome was bleeding events, while the primary efficacy outcome was MACEs including cardiac death, myocardial infarction, re-revascularization, or stroke during the 6-month follow-up.

A total of 2,046 patients (mean age 65.8 years, 70.5 percent men) completed the trial. Of these, 680 received enoxaparin, 683 received rivaroxaban 2.5 mg, and 683 received rivaroxaban 5 mg. Bleeding occurred in 46 patients (6.8 percent) in the enoxaparin group, 32 (4.7 percent) in the rivaroxaban 2.5-mg group, and 36 (5.3 percent) in the rivaroxaban 5-mg group (rivaroxaban 2.5 mg vs enoxaparin: hazard ratio [HR], 0.68, 95 percent confidence interval [CI], 0.43–1.07; p=0.005 for noninferiority; rivaroxaban 5 mg vs enoxaparin: HR, 0.88, 95 percent CI, 0.70–1.09; p=0.001 for noninferiority).

The incidence of MACEs did not differ across the three treatment groups, and noninferiority was met in the rivaroxaban 5-mg group (HR, 0.60, 95 percent CI, 0.31–1.16; p=0.02) but not in the rivaroxaban 2.5-mg group (HR, 0.68, 95 percent CI, 0.36–1.30; p=0.05).

The present data suggest that rivaroxaban 5 mg twice daily may be a potential alternative to enoxaparin in the acute phase of ACS.