Why the study?
Does rivaroxaban prevent stroke with acceptable safety compared to warfarin in patients with atrial fibrillation in everyday clinical practice?
Does rivaroxaban prevent stroke with acceptable safety compared to warfarin in patients with atrial fibrillation in everyday clinical practice?
Real-world observational studies of rivaroxaban in atrial fibrillation demonstrate lower rates of stroke and major bleeding compared to the ROCKET AF trial, reflecting a lower-risk patient population in everyday practice.
May reassure on safety in lower-risk AF practice; leaves open comparative effectiveness versus warfarin.
INTRODUCTION: Registries and non-interventional studies offer relevant and complementary information to clinical trials, since they have a high external validity. Areas covered: The information regarding the efficacy and safety of rivaroxaban compared with warfarin, or rivaroxaban alone in clinical practice was reviewed in this manuscript. For this purpose, a search on MEDLINE and EMBASE databases was performed. The MEDLINE and EMBASE search included both medical subject headings (MeSH) and keywords including: atrial fibrillation (AF) OR warfarin OR clinical practice OR ROCKET AF AND rivaroxaban. Case reports were not considered. Expert commentary: In ROCKET AF, rivaroxaban was at least as effective as warfarin for the prevention of stroke in patients with nonvalvular AF at high risk of stroke, but, importantly, with a lesser risk of intracranial, critical and fatal bleedings. A number of observational comparative and non-comparative studies, with more than 60,000 patients included treated with rivaroxaban, have analyzed the efficacy and safety of rivaroxaban in real-life patients with AF in different clinical settings. These studies have shown that in clinical practice, rates of stroke and major bleeding were consistently lower than those reported in ROCKET AF, likely due to the lower thromboembolic and bleeding risk observed in these patients.
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Barón‐Esquivias et al. (2017) studied this question.
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