Retrospective observational study assessing real-world clinical impact of switching or continuing Eliquis or rivaroxaban presented at the European Society of Cardiology (ESC) Congress 2023.- BMS + Pfizer

“Although some NVAF patients switch direct oral anticoagulants in real-world clinical practice, either for medical or non-medical reasons, there hasn’t been a lot of information gathered on the clinical outcomes of those switches,” said Steve Deitelzweig, MD, MMM, FACC, SFHM, FACP, RVT, System Chairman for Hospital Medicine, Ochsner Health System. “The study results provide insights about the real-world risk of stroke and major bleeding associated with switching from apixaban to rivaroxaban in patients with NVAF.”

This retrospective study identified NVAF patients who initiated Eliquis or rivaroxaban between 01 January 2013 and 31 December 2021 using Optum’s de-identified Clinformatics Data Mart database. There were 167,868 Eliquis initiators and 65,888 rivaroxaban initiators who met study criteria. Using propensity score matching (PSM), 2,900 patients who switched from Eliquis to rivaroxaban were matched to 14,500 patients who continued Eliquis, and 2,873 patients who switched from rivaroxaban to Eliquis were matched to 14,365 patients who continued rivaroxaban.

"Data collected in real-world settings can enhance patient care. By gathering insights from everyday clinical practice, we can better understand how Eliquis is used and its impact on patients’ lives,” said Narinder Bhalla, MD, Senior Vice President, Worldwide Medical, Head of Cardiovascular and Established Brands at Bristol Myers Squibb. “This real-world data provides pragmatic information to help clinicians manage the care of their patients.”

In this study, switching from Eliquis to rivaroxaban was associated with a higher risk of S/SE (stroke/systemic embolism ) (Hazard Ratio (HR):1.99, 95% Confidence Interval (CI): 1.38-2.88) and MB (HR: 1.80, 95% CI: 1.46-2.23) than those who continued Eliquis. Additionally, switching from rivaroxaban to Eliquis was associated with a similar risk of S/SE (HR:0.74, 95% CI: 0.45-1.22) and a lower risk of MB (HR:0.58, 95%CI: 0.44-0.76) compared to those who continued rivaroxaban. It is important to note that anticoagulants, including Eliquis, increase the risk of bleeding and can cause serious, potentially fatal bleeding. Please see important safety information below for Eliquis, including BOXED WARNINGS.

Real-world data have the potential to supplement randomized, controlled clinical trial data by providing additional information about how a medicine performs in routine medical practice. Real-world data analyses, however, have important limitations. Observational real-world studies can only evaluate association and not causality, and despite the use of methods to address differences due to measured variables, false associations may still be present. The source and type of data used may limit the generalizability of the results, and varied outcomes are possible.

In the ATHENS study, treatment assignments were based on pharmacy claims and actual drug exposure is unknown. Additionally, reasons for switching are not known and sample size for those who switched is much lower than those who continued treatment. Dosing criteria were not evaluated and impacts of drug dosing on outcomes were not assessed. Due to these limitations, real-world data analyses are not used as evidence to validate the efficacy and/or safety of a treatment.