1. In this randomized study comparing the efficacy of rivaroxaban with warfarin, dose-adjusted rivaroxaban treatment resulted in near doubling of risk for recurrent thrombosis.
2. The two treatment groups experienced similar bleeding outcomes, but patients in the rivaroxaban group had a higher stroke incidence rate.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Antiphospholipid Antibody Syndrome (APS) is a rare thrombophilic disorder treated primarily through long-term anticoagulation with vitamin K antagonists (VKA). However, this method has several notable disadvantages, including the need for frequent monitoring, the likelihood of food and drug interactions, and the increased risk of bleeding complications. With the advent of novel anticoagulation therapies, it is necessary to reevaluate whether this strategy ought to remain a mainstay amongst numerous alternatives. In this open-label noninferiority study, rivaroxaban failed to demonstrate noninferiority to warfarin for thrombotic APS, showing a non-statistically significant near doubling of risk for recurrent thrombosis. These findings were consistent with a previous rivaroxaban noninferiority study that showed not only a higher rate of thrombotic events but also a greater frequency of occurrence in arterial circulation. Additionally, stroke incidence was substantially higher in the rivaroxaban group. Limitations of this study included failure to assess anticoagulation intensity, reliance on exploratory post hoc analyses, and a small sample size with insufficient power to detect differences between patient subgroups.
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