OBJECTIVES: Non-vitamin K antagonist oral anticoagulants (NOACs) are a key treatment option to prevent thromboembolism in patients with atrial fibrillation (AF). The prevalence of AF in Italy has substantially increased over the past 20 years, yet there are no randomized clinical trials directly comparing the 4 available NOACs. The objective of this retrospective cohort study was to compare clinical outcomes for edoxaban vs other NOACs among patients with AF in Italy.

METHODS: Adult patients with AF and newly prescribed NOAC therapy between January 2016 and December 2021 were identified from the Italian IQVIA^® Longitudinal Patient Database, which holds anonymized patient consultation and treatment data from general practitioners (GPs). Patients were excluded if they received NOAC within 12 months before the new NOAC prescription. Patient characteristics were summarized and a propensity score-matched analysis was performed to compare clinical outcomes (systemic embolism [SE], ischemic stroke [IS], and major bleeding [MB]) for edoxaban with other NOACs. Clinical outcome incidence rates per 100 person-years and hazard ratios (HRs) with 95% confidence intervals (CIs) at 12 months of NOAC use were computed.

RESULTS: Overall, 16,747 patients were identified with 17.80% (n=2981) using dabigatran, 19.04% (n=3188) using edoxaban, 31.38% (n=5256) using apixaban, and 31.78% (n=5322) using rivaroxaban. After matching, most characteristics were similar in each cohort comparison. The adjusted risk (HR, 95% CI) of SE or IS was significantly lower for edoxaban vs apixaban (0.78, 0.61-0.99; P<0.05) or dabigatran (0.69, 0.54-0.89; P<0.05). The adjusted risk (HR, 95% CI) of MB was not significantly different between edoxaban vs dabigatran (0.98, 0.54-1.80; P=1.0), apixaban (1.09, 0.62-1.92; P=0.8), or rivaroxaban (0.89, 0.52-1.53; P=0.7).

CONCLUSIONS: While various NOACs exhibit similar MB incidence rates, their SE and IS rate demonstrated nuanced differences within routine clinical practice in Italy. These insights may provide valuable guidance for optimizing treatment recommendations and assist GPs in making informed decisions.