ARIVA
Trial question
What is the effect of aspirin plus rivaroxaban for the prevention of venous stent thrombosis in patients with post-thrombotic syndrome?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
61.0% female
39.0% male
N = 169
169 patients (103 female, 66 male).
Inclusion criteria: adult patients with post-thrombotic syndrome who were treated with venous stent placement.
Key exclusion criteria: age < 18 or > 75 years; contraindications to antithrombotic therapy; need for anticoagulants other than rivaroxaban; acute venous thrombosis.
Interventions
N=85 aspirin plus rivaroxaban (aspirin 100 mg/day plus rivaroxaban 20 mg/day for 6 months).
N=84 rivaroxaban alone (rivaroxaban 20 mg/day for 6 months).
Primary outcome
Rate of freedom from occlusion in the treated segment and re-intervention needed to maintain patency within 6 months
94.8%
92.4%
94.8 %
71.1 %
47.4 %
23.7 %
0.0 %
Aspirin plus
rivaroxaban
Rivaroxaban
alone
No significant
difference ↔
No significant difference in the rate of freedom from occlusion in the treated segment and re-intervention needed to maintain patency within 6 months (94.8% vs. 92.4%; AD 2.4%, 95% CI -13.6 to 18).
Secondary outcomes
No significant difference in reduction in Villalta score without ulcus after 6 months (6.7 points vs. 7 points; ARD 0.5, 95% CI -0.56 to 1.56).
No significant difference in sustained clinical success at 6 months (62.2% vs. 52%; AD 10.2%, 95% CI -6 to 26.3).
No significant difference in rate of open stents but > 50% residual stenosis at 3 months (2.7% vs. 1.3%; AD 1.4%, 95% CI -14.5 to 17.3).
Safety outcomes
No significant differences in adverse events, clinically relevant non-major bleeding event, minor bleeding event.
Conclusion
In adult patients with post-thrombotic syndrome who were treated with venous stent placement, aspirin plus rivaroxaban was not superior to rivaroxaban alone with respect to the rate of freedom from occlusion in the treated segment and re-intervention needed to maintain patency within 6 months.
Reference
Stefano Barco, Houman Jalaie, Tim Sebastian et al. Aspirin Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis Among Patients With Post-Thrombotic Syndrome: The Multicenter, Multinational, Randomized, Open-label ARIVA Trial. Circulation. 2025 Mar 25;151(12):835-846.
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