Lupus & antiphospholipid syndrome
Risk-stratified effectiveness of direct oral anticoagulants versus vitamin K antagonists in thrombotic antiphospholipid syndrome: a prospective cohort study
Main finding · Recurrent thrombosisResult — go to the resultHazard ratio 0.69 95% CI 0.27–1.75Authors' conclusion
In this prospective cohort, no statistically significant differences in recurrent thrombosis or major bleeding were observed between rivaroxaban and warfarin. The treatment-by-triple-positivity interaction suggests that the comparative effectiveness of anticoagulants may differ according to aPL profile.
Study context
- Population
- Patients with thrombotic antiphospholipid syndrome (APS) treated with rivaroxaban or warfarinpatients with thrombotic APS
- Participants
- 413 patients
- Exposure
- Rivaroxaban versus warfarin
- RIVAROXABANn = 89
- WARFARIN (VKA)n = 324reference
- Outcome
- Recurrent thrombosis
Methodological detailsinverse probability of treatment weighting, Cox models, prespecified subgroup analyses
- Inverse probability of treatment weighting
- Cox models
- Prespecified subgroup analyses
Main finding
As reported in the abstract
Hazard ratio
0.69
95% CI 0.27–1.75
P = 0.44
Events by group
RIVAROXABAN
6.7%; 3.02/100 patient-years
6 of 89
WARFARIN (VKA)
8.0%; 3.12/100 patient-years
26 of 324
RIVAROXABANvs WARFARIN (VKA)
HR 0.69 (95% CI 0.27–1.75); P = 0.44
Observational data: associations, not effects.
Further findings
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| Major bleedingWeighted analyses | 0.68 (0.15–3.03) | P = 0.61 | |
| Recurrent thrombosis in triple-positive patients (n=199)Higher risk with rivaroxaban | 3.65 (1.10–12.13) | ||
| Recurrent thrombosis in non-triple-positive patients (n=214)Trend toward lower risk with rivaroxaban | 0.16 (0.02–1.17) | P = 0.071 | |
| 0.050.21520Hazard ratio (log scale) |
Follow-up
- Follow-up — Median follow-up, months (IQR, 8.5-44.4)
- 25.1
- Recurrent thrombosis in triple-positive patients (n=199): P for interaction=0.007
Rivaroxaban-treated patients with prior arterial thrombosis
- Recurrent thrombotic events in those with prior arterial thrombosis
- 0/22
- Concomitant single antiplatelet therapy, prior arterial thrombosis vs others (p<0.001)
- 72.7% vs 11.9%
- Statins, prior arterial thrombosis vs others (p=0.002)
- 36.4% vs 7.5%
Original publication
Risk-stratified effectiveness of direct oral anticoagulants versus vitamin K antagonists in thrombotic antiphospholipid syndrome: a prospective cohort study. Lupus Sci Med. Published 9 November 2026. doi:10.
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