Background: In response to the TRAPS study, the MHRA have recommended avoidance of DOACS in all patients with antiphospholipid syndrome.

Aims: We performed a retrospective study of thrombotic and haemorrhagic outcomes in patients with APS and VTE receiving rivaroxaban in our centre.

Methods: Patients newly diagnosed with APS without prior exposure to warfarin between November 2016 and August 2019 and treated with rivaroxaban were included. APS was diagnosed based on persistent positivity of LA and/or ACA Ig over a 12 week period. We reviewed clinical records for evidence of thrombotic and haemorrhagic events whilst on rivaroxaban with reference to ISTH criteria of thrombosis and major, clinically relevant non-major bleeding (CRNMB) and minor bleeding episodes.

Results: 31 cases were identified. 30 cases were single positive, 1 double positive. Amongst 30 single positives, the presenting clinical feature was DVT in 53.3% (n=16), PE in 36.6 % (n=11) both PE and DVT in 6.6 % (n=2) and ischaemic stroke in 3.3 % (n=1). No new venous or arterial thrombotic events were reported throughout the study period. Median treatment duration with rivaroxaban was 723 days and total follow up period was 21,691 patient days. No major bleeding occurred, 6.6 % (n=2) patients reported CRNMB. Rate CRNMB was approximately 1 in 10,000 days.

Conclusions: In our study no new thrombotic events occurred in 21,691 days of treatment in patients with newly diagnosed single positive APS treated with rivaroxaban compared with 12% in 59 patients followed for median 569 days in TRAPS. Rates of major bleeding and CRNMB were also lower than reported in TRAPS . This small retrospective study suggests that the event rate in non-triple positive APS patients on rivaroxaban is less than that seen in TRAPS. Our results suggest further large prospective studies are required to address whether the TRAPS data is generalisable to non-triple positive APS.

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ISTH Congress Abstracts - https://abstracts.isth.org/abstract/observational-study-of-outcomes-in-patients-with-antiphospholipid-syndrome-anticoagulated-with-rivaroxaban/