The direct factor Xa inhibitor is also indicated for the treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and PE, prevention of stroke and systemic embolism in non-valvular atrial fibrillation, and prevention of venous thromboembolism (VTE) in adults undergoing elective hip or knee replacement surgery.
The open-label EINSTEIN-PE study investigated the use of rivaroxaban in the treatment of acute symptomatic PE with or without DVT. Participants (n=4832) were randomised to receive either rivaroxaban (15mg twice daily for three weeks, followed by 20mg once daily) or standard therapy (enoxaparin 1mg/kg twice daily followed by dose-adjusted warfarin or acenocoumarol to maintain an INR of 2.0–3.0). Treatment continued for 3, 6 or 12 months, as determined by the treating physician.
Non-inferior to enoxaparin/warfarin regimen
Intention-to-treat analysis showed that rivaroxaban was non-inferior to standard therapy (p=0.003) in terms of symptomatic recurrent VTE (the primary efficacy end point), which occurred in 2.1% of patients in the rivaroxaban group and 1.8% of those in the standard therapy group (hazard ratio 1.12, 95% CI 0.75–1.68).
No difference in primary safety outcome over standard treatment
There was no significant difference in the rate of major or clinically relevant non-major bleeding (the primary safety outcome) between the two groups. However, major bleeding was significantly reduced with rivaroxaban: 1.1% vs 2.2% (hazard ratio 0.49, 95% CI 0.31–0.79, p=0.003).
Further information: Bayer plc