UTILIZATION AND CLINICAL OUTCOMES OF DIRECT ORAL ANTICOAGULANTS IN REAL-WORLD SETTINGS: EVIDENCE FROM A GLOBAL FEDERATED RESEARCH NETWORK IN EUROPE
Author(s)
Angel F. Valladares, MPH1, Joseph Imperato, MSc1, Sidharth Gupta, B.Tech2, Rosa Wang, MHA3, Dong Dai, MBA, PhD3, Xin Ye, MS, PhD3;
1IQVIA, New York, NY, USA, 2IQVIA, Bengaluru, India, 3Daiichi Sankyo, Inc., Basking Ridge, NJ, USA
1IQVIA, New York, NY, USA, 2IQVIA, Bengaluru, India, 3Daiichi Sankyo, Inc., Basking Ridge, NJ, USA
OBJECTIVES: To evaluate patient characteristics and clinical outcomes (systemic embolism, ischemic stroke, major bleeding) associated with direct oral anticoagulant (DOAC) use in real-world European clinical practice.
METHODS: This retrospective cohort study utilized electronic medical records from the TriNetX global federated health research network, encompassing 52 healthcare organizations across the UK, Germany, Italy, Spain, and Belgium. Adults (≥18 years) with atrial fibrillation (AF) initiating edoxaban, apixaban, dabigatran, or rivaroxaban between 2016 and 2022 were included. Patients with mitral stenosis, valve replacement, deep vein thrombosis, pulmonary embolism, or prior DOAC/vitamin K antagonist use were excluded. Baseline characteristics and outcome incidence rates were compared descriptively across DOAC cohorts. Incidence rate ratios (IRRs) and 95% confidence intervals (CIs) of other DOACs vs edoxaban were calculated for the effectiveness (systemic embolism, ischemic stroke) and safety (major bleeding) outcomes.
RESULTS: Overall, 77,813 patients were identified (edoxaban: 14,743; apixaban: 42,414; dabigatran: 5003; rivaroxaban: 15,653). Baseline characteristics were similar across DOACs (mean age: 73.7 years; 42.2% female). Effectiveness/safety incidence rates per 100 person‑years were as follows: edoxaban 3.10/3.56; apixaban 3.80/3.84; dabigatran 4.65/3.20; rivaroxaban 2.80/3.75. Compared with edoxaban, the IRRs of effectiveness outcomes were 0.82 (95% CI: 0.75-0.88, P <0.001) for apixaban, 0.67 (95% CI: 0.59-0.75, P <0.001) for dabigatran, and 1.11 (95% CI: 1.00-1.22, P = 0.05) for rivaroxaban. The IRRs of safety outcomes compared with edoxaban were 0.93 (95% CI: 0.86-0.99, P = 0.04) for apixaban, 1.11 (95% CI: 0.98-1.27, P = 0.11) for dabigatran, and 0.95 (95% CI: 0.87-1.04, P = 0.25) for rivaroxaban.
CONCLUSIONS: In this large, real-world European cohort, IRRs suggest that edoxaban was associated with better effectiveness outcomes compared with apixaban or dabigatran, and with comparable safety outcomes versus other DOACs in patients with AF. Given the observational design, further treatment comparison studies with adjustment for potential confounding factors are needed to confirm these findings.
METHODS: This retrospective cohort study utilized electronic medical records from the TriNetX global federated health research network, encompassing 52 healthcare organizations across the UK, Germany, Italy, Spain, and Belgium. Adults (≥18 years) with atrial fibrillation (AF) initiating edoxaban, apixaban, dabigatran, or rivaroxaban between 2016 and 2022 were included. Patients with mitral stenosis, valve replacement, deep vein thrombosis, pulmonary embolism, or prior DOAC/vitamin K antagonist use were excluded. Baseline characteristics and outcome incidence rates were compared descriptively across DOAC cohorts. Incidence rate ratios (IRRs) and 95% confidence intervals (CIs) of other DOACs vs edoxaban were calculated for the effectiveness (systemic embolism, ischemic stroke) and safety (major bleeding) outcomes.
RESULTS: Overall, 77,813 patients were identified (edoxaban: 14,743; apixaban: 42,414; dabigatran: 5003; rivaroxaban: 15,653). Baseline characteristics were similar across DOACs (mean age: 73.7 years; 42.2% female). Effectiveness/safety incidence rates per 100 person‑years were as follows: edoxaban 3.10/3.56; apixaban 3.80/3.84; dabigatran 4.65/3.20; rivaroxaban 2.80/3.75. Compared with edoxaban, the IRRs of effectiveness outcomes were 0.82 (95% CI: 0.75-0.88, P <0.001) for apixaban, 0.67 (95% CI: 0.59-0.75, P <0.001) for dabigatran, and 1.11 (95% CI: 1.00-1.22, P = 0.05) for rivaroxaban. The IRRs of safety outcomes compared with edoxaban were 0.93 (95% CI: 0.86-0.99, P = 0.04) for apixaban, 1.11 (95% CI: 0.98-1.27, P = 0.11) for dabigatran, and 0.95 (95% CI: 0.87-1.04, P = 0.25) for rivaroxaban.
CONCLUSIONS: In this large, real-world European cohort, IRRs suggest that edoxaban was associated with better effectiveness outcomes compared with apixaban or dabigatran, and with comparable safety outcomes versus other DOACs in patients with AF. Given the observational design, further treatment comparison studies with adjustment for potential confounding factors are needed to confirm these findings.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
CO84
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory)