Effect of Rivaroxaban + Aspirin vs Acenocoumarol in recurrent venous thromboembolism

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Created On: 01/03/2023

A pilot randomized clinical trial was carried out to investigate Rivaroxaban + Aspirin vs Acenocoumarol in individuals suffering from recurrent venous thromboembolism despite ongoing anticoagulation with Rivaroxaban.

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Key take away

In terms of outcomes, there is no significant difference between Rivaroxaban + Aspirin vs Acenocoumarol in patients with recurrent venous thromboembolism.

Background

Method

In this multicenter study, volunteers with objectively proven recurrent venous thromboembolism were randomly allocated to get either an adjusted dose of Acenocoumarol or the combination of Rivaroxaban (20 mg once daily) and Aspirin (300 mg once daily). Prevalence of hemorrhagic events and recurring thromboembolic events, encompassing ipsilateral or contralateral deep vein thrombosis (DVT), pulmonary embolism, myocardial infarction, and ischemic stroke.

Result

A total of 58 patients were randomly assigned: 30 to the Acenocoumarol group and 28 to the Rivaroxaban + Aspirin group. Following 90 days of follow-up, the Acenocoumarol group experienced three recurrent thromboembolic events (key endpoint), encompassing two DVTs and one ischemic stroke.

On the other hand, Rivaroxaban + Aspirin group experienced zero occurrences (risk ratio [RR] 0.15). Five participants in the Acenocoumarol group and none in the Rivaroxaban + Aspirin group experienced minor bleeding (RR 0.09). Rivaroxaban + Aspirin group experienced one non-fatal large gastrointestinal bleed.

Conclusion

No profound difference was noted in any of the outcomes evaluated. But, minor bleeding events and recurrent thromboembolic events occurred numerically less commonly in the Rivaroxaban + Aspirin group. These findings point to the necessity of conducting larger, more robust, randomized trials with adequate statistical power to shed light on these findings.