Therefore, rivaroxaban did not show noninferiority to dose-adjusted VKAs for thrombotic APS and, in fact, showed a non–statistically significant near doubling of the risk for recurrent thrombosis. There was no difference in major bleeding between the two groups.
Patients were randomised to receive rivaroxaban (20 mg/d or 15 mg/d, according to renal function) vs dose-adjusted VKAs (target INR 2.0 to 3.0, or 3.1 to 4.0 in patients with a history of recurrent thrombosis).
Of note, the MHRA has previously (June 2019) issued a warning stating that direct-acting oral anticoagulants (DOACs) are not recommended in patients with antiphospholipid syndrome, particularly high-risk patients (those who test positive for all 3 antiphospholipid tests — lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2 glycoprotein I antibodies).