Abstract Number: PB1062
Meeting: ISTH 2021 Congress
Background: Vitamin K antagonists (VKA) such as Warfarin are the mainstay of therapy in Antiphospholipid Syndrome (APS) but this entails frequent INR monitoring, increased bleeding and multiple drug and food interactions. Direct oral anticoagulants such as Rivaroxaban present an alternative and novel therapeutic approach to APS management.
Aims: This study aimed to assess the effect of Rivaroxaban compared with VKA on recurrent thrombosis and major bleeding among patients with APS.
Methods: We included studies satisfying the following criteria:
1) Randomized controlled trials (RCT);
3) recurrent thrombosis andmajor bleeding.
We searched for eligible studies in PUBMED, Clinical Key, Science Direct, Cochrane, Google Scholar, and ClinicalTrials.gov from November 1 to December 31, 2019 and assessed their quality using the Cochrane Risk of Bias Tool. Our primary outcomes of interest included the effect of Rivaroxaban compared to VKA on
1) recurrent thrombosis and
2) major bleeding.
We used Review Manager(RevMan 5.3) for analysis and reported risk ratios (RR) and 95% confidence intervals(CI).
Results: Three RCTs with 424 patients were included. There is no significant difference between Rivaroxaban and VKA in terms of overall recurrent thrombosis, but Rivaroxaban use shows a trend towards harm (RR 4.08, CI 0.48-34.79, P=0.13, I2=57%). Subgroup analysis revealed that there is increased risk of stroke with Rivaroxaban compared to VKA (RR 14.13, CI 1.87-106.81, P 0.01, I2=0%). There is no significant difference between Rivaroxaban and VKA in terms of venous thrombosis.In terms of the primary safety outcome of major bleeding, there is no significant difference between Rivaroxaban and VKA (RR 1.10, CI 0.45-2.68, p=0.83, I2=0%).
Conclusions: There is no conclusive evidence that Rivaroxaban is efficacious in preventing recurrent thrombosis among patients with APS. There is a signal towards harm in terms of stroke and evidence is equivocal in terms of venous thrombosis and major bleeding. Rivaroxaban cannot be recommended as an alternative toVKA at this time.
To cite this abstract in AMA style:Agustin RD, Villanueva DL, Alajar E, Abola MT. Rivaroxaban versus Vitamin K Antagonist for the Secondary Prevention of Recurrent Thrombosis in Antiphospholipid Syndrome: A Systematic Review and Meta-analysis [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/rivaroxaban-versus-vitamin-k-antagonist-for-the-secondary-prevention-of-recurrent-thrombosis-in-antiphospholipid-syndrome-a-systematic-review-and-meta-analysis/. Accessed November 28, 2022.
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