ELIQUIS is the only factor Xa inhibitor that has demonstrated significant risk reduction in stroke / systemic embolism with significantly less major bleeding vs. warfarin.1
For further details of the limitations of this analysis, please refer to the full publication.2
There are no adequate and well-controlled head-to-head clinical trials comparing efficacy and safety of ELIQUIS to any of the other NOACs. Hence, the analysis presented does not imply a comparison of efficacy, safety, or product interchangeability.
Patients taking ELIQUIS in a real-world setting had significantly reduced risks of stroke / systemic embolism and major bleeding vs. warfarin.2
Adapted from Granger et al. 20111 and Yao et al. 2016.2
* ARISTOTLE was a randomised, double-blind, double-dummy non-inferiority trial in 18,201 patients. Stroke / systemic embolism was the primary efficacy endpoint and major bleeding was the primary safety endpoint. The primary safety outcome was major bleeding, according to the criteria of the International Society on Thrombosis and Haemostasis (ISTH). Pre-specified hierarchical sequential testing was performed first on stroke / systemic embolism (primary efficacy endpoint) for non-inferiority, then for superiority, then on major bleeding, and finally on death from any cause (secondary endpoint).1
† The definition of efficacy and safety in the ARISTOTLE clinical trial was different than in the USA real-world analysis.1,2
‡ The USA real-world analysis’s primary effectiveness outcome was stroke or systemic embolism, including ischaemic stroke, haemorrhagic stroke, and systemic embolism. The primary safety outcome was major bleeding, including gastrointestinal bleeding, intracranial bleeding, and bleeding from other sites.2 Edoxaban was not included in this study analysis as it was not yet FDA approved during the time periods analysed.2
§ Hazard ratio for pairwise propensity-matched medication comparison (ELIQUIS vs. warfarin).2
432UK1800479-05 – May 2018
For a copy of the ELIQUIS (apixaban) prescribing and adverse event reporting information, please select the 'Prescribing and Adverse Event Reporting Information' tab at the top of this page.
To assess the effectiveness and safety of ELIQUIS, dabigatran and rivaroxaban for stroke prevention in NVAF patients, in a large USA contemporary evaluation comparing NOACs and warfarin.
The introduction of NOACs has been a major advance for stroke prevention in atrial fibrillation; however, outcomes achieved in clinical trials may not translate to routine practice.
Primary effectiveness outcome: stroke or systemic embolism, including ischaemic stroke, haemorrhagic stroke, and systemic embolism.
Primary safety outcome: major bleeding, including gastrointestinal bleeding, intracranial bleeding, and bleeding from other sites.
Three 1:1 propensity score matched cohorts:
Using Cox proportional hazards regression, the authors found that, for stroke or systemic embolism, ELIQUIS was associated with lower risk (HR=0.67, 95% CI: 0.46–0.98, p=0.04), compared with warfarin. For major bleeding, ELIQUIS was associated with lower risk (HR=0.45, 95% CI: 0.34–0.59, p<0.001) compared with warfarin.
In patients with NVAF, ELIQUIS was associated with lower risks of stroke and major bleeding compared with warfarin.
This study was funded by the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery.