From the Guidelines
Rivaroxaban and apixaban have been extensively studied in clinical trials, including the ROCKET AF and ARISTOTLE trials, which demonstrated their efficacy and safety in preventing stroke and systemic embolism in patients with nonvalvular atrial fibrillation 1.
Clinical Trials
The ROCKET AF trial compared rivaroxaban with warfarin in 14,264 patients with nonvalvular atrial fibrillation, and found that rivaroxaban was noninferior to warfarin in preventing stroke and systemic embolism, with a lower risk of intracranial hemorrhage and fatal bleeding 1.
- The ARISTOTLE trial compared apixaban with warfarin in 18,201 patients with nonvalvular atrial fibrillation, and found that apixaban was superior to warfarin in preventing stroke and systemic embolism, with a lower risk of major bleeding and intracranial hemorrhage 1.
- The AVERROES trial compared apixaban with aspirin in 5,599 patients with nonvalvular atrial fibrillation who were unsuitable for warfarin therapy, and found that apixaban was superior to aspirin in preventing stroke and systemic embolism, with a similar risk of bleeding 1.
Key Findings
- Rivaroxaban and apixaban are direct oral anticoagulants that inhibit Factor Xa in the coagulation cascade.
- They offer advantages over traditional vitamin K antagonists like warfarin, including more predictable pharmacokinetics, fewer drug interactions, no routine monitoring requirements, and fixed dosing regimens.
- However, dose adjustments are needed for patients with renal impairment, and these medications should be used cautiously in patients with severe liver disease.
Recommendations
Based on the most recent and highest quality evidence, rivaroxaban and apixaban are recommended for stroke prevention in patients with nonvalvular atrial fibrillation, with a preference for apixaban due to its superior efficacy and safety profile 1.
From the FDA Drug Label
The evidence for the efficacy and safety of XARELTO was derived from Rivaroxaban Once-daily oral direct factor Xa inhibition Compared with vitamin K antagonist for the prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) [NCT00403767], a multi-national, double-blind study comparing XARELTO (at a dose of 20 mg once daily with the evening meal in patients with CrCl >50 mL/min and 15 mg once daily with the evening meal in patients with CrCl 30 to 50 mL/min) to warfarin (titrated to INR 2.0 to 3. 0) to reduce the risk of stroke and non-central nervous system (CNS) systemic embolism in patients with nonvalvular atrial fibrillation (AF)
The clinical trial conducted on Rivaroxaban (Xarelto) was the ROCKET AF study, a multi-national, double-blind study that compared XARELTO to warfarin in patients with nonvalvular atrial fibrillation (AF) 2.
- The study was designed to demonstrate that XARELTO preserved more than 50% of warfarin's effect on stroke and non-CNS systemic embolism.
- A total of 14264 patients were randomized and followed on study treatment for a median of 590 days.
- The primary endpoint was the time to first occurrence of stroke (any type) or non-CNS systemic embolism. There is no information about clinical trials on Apixaban (Eliquis) in the provided text.
From the Research
Clinical Trials on Rivaroxaban (Xarelto) and Apixaban (Eliquis)
- Several clinical trials have been conducted to compare the effectiveness and safety of Rivaroxaban and Apixaban in patients with atrial fibrillation, including:
- A study published in 2017 3 that summarized the effectiveness of rivaroxaban versus warfarin and other direct oral anticoagulants (DOACs) in patients with nonvalvular atrial fibrillation.
- A population-based study published in 2022 4 that compared the effectiveness and safety of apixaban and rivaroxaban in patients with atrial fibrillation and valvular heart disease.
- A cohort study published in 2020 5 that compared the safety and effectiveness of apixaban versus rivaroxaban for patients with nonvalvular atrial fibrillation.
- A review published in 2012 6 that discussed the efficacy and safety of direct oral factor Xa-inhibitors, including rivaroxaban and apixaban, in clinical studies.
- A retrospective cohort study published in 2021 7 that compared major ischemic and hemorrhagic outcomes in patients with atrial fibrillation treated with rivaroxaban or apixaban.
Key Findings
- The studies found that apixaban was associated with a lower rate of ischemic stroke or systemic embolism and bleeding compared to rivaroxaban in patients with atrial fibrillation 4, 5, 7.
- Rivaroxaban was found to be superior to warfarin and similar to dabigatran, apixaban, and edoxaban for the prevention of stroke or systemic embolism in patients with nonvalvular atrial fibrillation, although it may be associated with an elevated bleeding risk compared to other DOACs 3.
- The direct oral factor Xa-inhibitors, including rivaroxaban and apixaban, have been shown to be non-inferior or superior compared to vitamin K antagonists or low-molecular weight heparins, and are considered a progress for the appropriate patients in terms of quality of treatment 6.