NAXOS real-world study of Eliquis shows reduced bleeding and stroke in non-valvular atrial fibrillation.- BMS/Pfizer

Bristol-Myers Squibb/Pfizer announced findings from NAXOS, the largest real-world data analysis on oral anticoagulant (OAC) effectiveness and safety in Europe evaluating Eliquis (apixaban) among patients with non-valvular atrial fibrillation (NVAF). NAXOS is a retrospective cohort analysis including nearly all patients in France aged 18 years or older with NVAF newly initiating one of the OACs between 2014 and 2016 (n=321,501). In this analysis, Eliquis use was associated with a lower rate of major bleeding compared to a vitamin K antagonist (VKA) (hazard ratio [HR]: 0.49, 95% confidence interval [CI]: 0.46-0.52), rivaroxaban (HR: 0.63, 95% CI: 0.58-0.67) and dabigatran (HR: 0.85, 95% CI: 0.76-0.95). In this analysis, Eliquis was also associated with lower rates of stroke and systemic thromboembolic events compared to VKA (HR: 0.67, 95% CI: 0.62-0.72) and rates similar to rivaroxaban (HR: 0.97, 95% CI: 0.89-1.05) or dabigatran (HR: 0.92, 95% CI: 0.81-1.06).

Eliquis was associated with a lower rate of all-cause mortality compared to VKA (HR: 0.56, 95% CI: 0.54-0.58) and rivaroxaban (HR: 0.89, 95% CI: 0.85-0.93) and rates similar to dabigatran (HR: 0.94, 95% CI: 0.87-1.01). It is important to note that there are no head-to-head clinical trials comparing non-vitamin K antagonist OACs. These data were featured as a late-breaking oral presentation at the European Society of Cardiology (ESC) Congress 2019 in Paris, France (Abstract 1362).

Comment: Real-world data have the potential to complement randomized controlled clinical trial data by providing additional information about how a medicine performs in routine medical practice. Real-world data analyses also have several limitations. For example, the source and type of data used may limit the generalizability of the results and endpoints. Observational real-world studies can only evaluate association and not causality, and despite the use of methods to address measured confounding, residual confounding may still be present. Due to its limitations, real-world data analyses are not used as stand-alone evidence to validate the efficacy and/or safety of a treatment.