Lupus & antiphospholipid syndrome

Direct oral anticoagulants versus Vitamin K antagonists in antiphospholipid syndrome: A systematic review and meta-analysis

Semin Arthritis RheumPublished Systematic review and meta-analysis of randomised and observational studies

Pooled result · Composite of ATE and VTEResult — go to the resultIncidence rate ratio 2.33 95 % CI 1.18–4.58

Authors' conclusion

In patients with thrombotic APS, the use of DOACs is associated with increased thrombotic events compared with VKAs, mainly driven by arterial thrombotic events.

Study context

Population
Patients with thrombotic antiphospholipid syndrome (APS)12 studies (4 randomized controlled trials (RCTs), 8 observational)
Participants
1,307 patients
Comparison
Direct oral anticoagulants (DOACs) vs Vitamin K antagonists (VKAs)
Outcome
Composite of:
  • Arterial (ATE)
  • Venous thrombotic events (VTE)
Methodological detailsGRADE certainty of evidence, incidence rate ratios
  • GRADE certainty of evidence
  • Incidence rate ratios

Pooled result

Composite of:

  • ATE
  • VTE

Incidence rate ratio

2.33

95 % CI 1.18–4.58

DOACsvs VKAs
IRR 2.33 (95 % CI 1.18–4.58)

As reported in the abstract

Further pooled results

OutcomeIRR (95 % CI)
Arterial thrombotic events (ATE)GRADE=low · increased ATE drove the increase in the primary endpoint2.70 (1.42–5.13)
MIGRADE=very low4.71 (1.00–22.21)
StrokeGRADE=very low7.48 (1.27–44.13)
  • Arterial thrombotic events (arterial (ATE)): increased risk consistently observed in a dedicated analysis of RCTs; mitigated by concomitant single antiplatelet therapy

Venous thrombotic events (VTE)

VTE did not differ significantly between groups (IRR)
0.98; 95 % CI 0.59-1.64
  • GRADE=low

Safety

Major bleeding

Major bleeding did not differ significantly between groups (IRR)
0.83; 95 % CI 0.48-1.43
  • GRADE=low

Non-major bleeding

Non-major bleeding did not differ significantly between groups (IRR)
1.32; 95 % CI 0.81-2.14
  • GRADE=very low

Original publication

Direct oral anticoagulants versus Vitamin K antagonists in antiphospholipid syndrome: A systematic review and meta-analysis. Semin Arthritis Rheum. Published 1 May 2025. doi:10.1016/j.semarthrit.2025.152741

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