Author: Prof. Dr. Stefano Barco

Institution: University Hospital Zurich, Switzerland

Summary

This report presents the latest findings from the ARIVA Phase III Randomized Controlled Trial, which evaluated the efficacy of combining aspirin with rivaroxaban compared to rivaroxaban alone in preventing venous stent thrombosis. The results indicate that aspirin combined with rivaroxaban did not significantly outperform rivaroxaban alone, with both groups showing higher-than-expected primary patency rates. This highlights the high efficacy and safety of venous stents in treating post-thrombotic syndrome (PTS).

Study Design

•Design: The ARIVA trial is an international, multicenter, open-label Phase III randomized controlled trial aimed at evaluating the difference in primary patency rates between aspirin plus rivaroxaban and rivaroxaban alone over 6 months.

•Primary Endpoint: Primary patency, defined as the absence of stent segment occlusion or the need for reintervention to maintain patency within 6 months .

•Secondary Endpoints:These include secondary patency rates between 3 to 6 months, resolution of PTS, ultrasound results (partial stent thrombosis), and patient quality of life scores (PPT 10).

Results

•Primary Patency Rate: The study showed a primary patency rate of 94.8% in the aspirin plus rivaroxaban group, compared to 92.4% in the rivaroxaban alone group, with no significant difference between the two groups (95% CI difference: -13.6% to +18.0%).

•Safety Analysis: Neither group experienced major bleeding events. However, the aspirin plus rivaroxaban group reported a higher rate of clinically relevant non-major bleeding (CRNM) at 8.2%, compared to 2.4% in the rivaroxaban alone group.

Conclusion

1. The ARIVA trial is the first randomized controlled trial on antithrombotic therapy for patients with post-thrombotic syndrome following venous stent placement. The results indicate that combining aspirin with rivaroxaban does not significantly outperform rivaroxaban alone in preventing stent thrombosis.

2. Both groups showed higher-than-expected primary patency rates, confirming the efficacy and safety of venous stents in treating PTS.

3. While the combined therapy did not show a significant advantage in the primary endpoint, its safety outcomes warrant further investigation to ensure the best antithrombotic therapy strategy.

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