Rivaroxaban was noninferior to warfarin for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, occurring in 1.7% of patients on rivaroxaban versus 2.2% on warfarin (p<0.001 for noninferiority).
Does rivaroxaban provide safe and efficacious anticoagulation compared to warfarin in high-risk subpopulations of patients with atrial fibrillation?
This review summarizes ROCKET AF subanalyses, confirming rivaroxaban as an efficacious alternative to warfarin across various high-risk AF patient groups, while noting specific safety profiles like increased GI bleeding.
Absolute Event Rate: 1.7% vs 2.2%
p-value: p=<0.001 for non-inferiority
BACKGROUND: The safety and efficacy of the oral anticoagulant rivaroxaban were studied in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF trial). A number of subanalyses of the ROCKET AF trial have subsequently analyzed the use of rivaroxaban in special patient populations. METHODS: The outcomes of the ROCKET AF trial were reviewed. The use of rivaroxaban in higher risk populations, as determined by the presence of co-morbidities included in the CHADS2 criteria, was analyzed. Requirements for dose adjustment in patients with renal impairment and in East Asian patients were described. Finally, clinical management challenges, including interruptions in therapy, drug discontinuation, management of bleeding events, drug interactions, and management of patients requiring cardioversion/ablation were reviewed. RESULTS: Rivaroxaban is efficacious in high-risk populations, including elderly patients, patients with diabetes, heart failure, history of stroke, prior myocardial infarction, or peripheral arterial disease (PAD). Patients with PAD have a higher risk of bleeding with rivaroxaban compared with warfarin. East Asian populations do not require a dose adjustment for rivaroxaban, while a reduced dose of 15 mg daily is required for patients with moderate renal impairment. Rivaroxaban remains effective with temporary interruptions in therapy and in patients requiring cardioversion/ablation. Rates of major bleeding and subsequent outcomes were similar in patients on warfarin and rivaroxaban, although rates of gastrointestinal bleeding were higher with rivaroxaban. Concurrent use of antiarrhythmic therapy was not associated with adverse outcomes. CONCLUSIONS: Rivaroxaban represents an efficacious alternative to warfarin in high-risk patients with AF. Dose adjustment is required for patients with moderate renal impairment. Rivaroxaban can be used safely in a number of challenging clinical management scenarios although the concurrent use of amiodarone requires more study.
Shah et al. (Wed,) conducted a review in Nonvalvular atrial fibrillation (n=14,264). Rivaroxaban vs. Dose-adjusted warfarin was evaluated on Composite of stroke and systemic embolism (p=<0.001 for non-inferiority). Rivaroxaban was noninferior to warfarin for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, occurring in 1.7% of patients on rivaroxaban versus 2.2% on warfarin (p<0.001 for noninferiority).