Edoxaban versus Apixaban Outcomes Differences in 8,444 Patients with Atrial Fibrillation from Italy: A Real-World Use Comparison.

BACKGROUND

Based on efficacy and safety data from randomized controlled trials (RCTs) and real-world studies, direct oral anticoagulants are recommended for thromboembolism prevention in patients with atrial fibrillation (AF). However, no RCTs have compared edoxaban with apixaban.

OBJECTIVES

This study aimed to retrospectively compare clinical outcomes for patients with AF in Italy (overall and by age group) who received edoxaban versus apixaban.

METHODS

Adult patients with AF who newly initiated an edoxaban or apixaban prescription between January 2016 and December 2021 were identified from the Italian IQVIA ® Longitudinal Patient Database. Patient characteristics were summarized. Propensity score matching was used to balance baseline characteristics between the edoxaban and apixaban groups. Clinical outcomes of effectiveness (ischemic stroke [IS] or systemic embolism [SE]) and safety (any major bleeding [MB]) were compared. Incidence rates per 100 person-years and hazard ratios (HRs) with 95% CIs were computed.

RESULTS

Among 8,444 identified patients, 37.8% ( n  = 3,188) were prescribed edoxaban and 62.2% ( n  = 5,256) were prescribed apixaban. After matching, patient characteristics were similar between cohorts. The post-matching risk (HR, 95% CI) of IS/SE was significantly lower for edoxaban versus apixaban in the overall population (0.78, 0.61-0.99; p  = 0.04) and in patients aged ≥80 years (0.61, 0.44-0.86; p  < 0.01), with a similar risk for MB for edoxaban versus apixaban. No significant differences were observed between edoxaban and apixaban among patients aged <80 years (all p  > 0.05).

CONCLUSION

IS/SE risk was significantly lower for edoxaban versus apixaban, without an increased MB risk among patients with AF overall and those aged ≥80 years.