TRAPS
Trial question
Is rivaroxaban noninferior to warfarin in high-risk patients with thrombotic antiphospholipid syndrome?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
64.0% female
36.0% male
N = 120
120 patients (77 female, 43 male).
Inclusion criteria: high-risk patients with thrombotic antiphospholipid syndrome.
Key exclusion criteria: severe hypersensitivity to rivaroxaban, pregnancy or breast feeding, concomitant treatment with other anticoagulants, major surgical procedure or trauma within 30 days, gastrointestinal bleeding within 6 months of randomization, chronic hemorrhagic disorder, intracranial neoplasm, AVM or aneurysm.
Interventions
N=59 rivaroxaban (20 mg once daily; 15 mg once daily based on kidney function).
N=61 warfarin (INR target 2.5).
Primary outcome
Vascular death, thromboembolic events, or major bleeding
19%
3%
19.0 %
14.3 %
9.5 %
4.8 %
0.0 %
Rivaroxaban
Warfarin
Difference exceeding
non-inferiority
margin ✗
Difference exceeding non-inferiority margin in vascular death, thromboembolic events, or major bleeding (19% vs. 3%; HR 6.7, 95% CI 1.5 to 30.5).
Secondary outcomes
No significant difference in major bleeding (7% vs. 3%; HR 2.5, 95% CI 0.5 to 13.6).
Conclusion
In high-risk patients with thrombotic antiphospholipid syndrome, rivaroxaban was not noninferior to warfarin with respect to vascular death, thromboembolic events, or major bleeding.
Reference
Pengo V, Denas G, Zoppellaro G et al. Rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome. Blood. 2018 Sep 27;132(13):1365-1371.
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