Pulmonary vascular disease & thromboembolismRandomised controlled trial
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
- Randomised controlled trial
- open-label
- multicentre
- multinational
- independently adjudicated
Authors' conclusion
The overall primary patency rate during the first 6 months after endovascular intervention for post-thrombotic syndrome was higher than expected and comparable between patients receiving aspirin combined with rivaroxaban and those receiving rivaroxaban alone.
Study context
- Population
- Patients with post-thrombotic syndrome (Villalta score >4) successfully treated with venous stent placement for stenosis or occlusion of the inferior vena cava, iliac or common femoral vein162 in full analysis set
- Participants
- 169 patients
- Comparison
- Aspirin plus rivaroxaban vs rivaroxaban alone
- Aspirin plus rivaroxabann = 80
- Rivaroxaban alonen = 82reference
- Primary endpoint
- Primary patency: no occlusion of the treated segment on serial duplex ultrasound or no reintervention needed to maintain patency
- Follow-up
- 6 months
Primary result
As reported in the abstract
Primary patency rate, aspirin plus rivaroxaban vs rivaroxaban alone (in that order, "respectively")
94.8% vs 92.4%
Absolute risk difference, aspirin plus rivaroxaban vs rivaroxaban alone
2.4% (95% CI, −13.6 to 18.0)
Secondary outcomes
Mean±SD decrease in Villalta score, affected leg (without ulcer), baseline to 6 months
- Villalta score change, aspirin plus rivaroxaban vs rivaroxaban alone (in that order, "respectively")
- −6.7±4.4 vs −7.0±5.2 points (P=0.36)
Other outcomes and quality of life · 6 months
- No differences in other outcomes or quality of life
Safety
Major bleeding
- No major bleeding occurred
Original publication
Summarised from the published abstract; every number is checked against it