Outcomes of edoxaban-treated patients with atrial fibrillation and concomitant vascular disease in daily clinical practice: insights from ETNA-AF-Europe

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Daiichi Sankyo Europe OnBehalf ETNA-AF-Europe investigators Background Coronary (CAD) and peripheral artery disease (PAD) are common comorbidities in patients with atrial fibrillation (AF). Such concomitant vascular disease may affect the effectiveness and safety of treatment with edoxaban, but data from daily practice are limited. Purpose: To determine the incidence of ischaemic and bleeding events in edoxaban-treated AF patients with CAD/PAD, and to assess whether the effect of edoxaban might be influenced by concomitant vascular disease. Methods: With 1-year follow-up data from ETNA-AF-Europe, clinical characteristics and frequencies of adverse events were compared between AF-patients with and without CAD/PAD. Results: Of 13,089 patients, 2956 had vascular disease (n = 2738; 92.6% had CAD). Patients with CAD/PAD were older, had lower creatinine clearance, higher stroke and bleeding risk scores, and were more frequently prescribed the reduced dose of edoxaban than those without these comorbidities (Table). Rates of stroke/systemic embolism (0.99 vs 0.77%/year), and major bleeding (1.28 vs 0.98%/year) were numerically higher in patients with CAD/PAD than in those without. Myocardial infarction (1.31 vs 0.30%/year), cardiovascular deaths (2.33 vs 1.43%/year) as well as all-cause deaths (5.18 vs 3.01%/year) occurred significantly more often in the CAD/PAD subgroup (Figure). Conclusions: Rates of ischaemic and bleeding events are low in unselected edoxaban-treated AF patients, regardless of the presence/absence of concomitant vascular disease. The higher rates of myocardial infarction and (non-)cardiovascular death in the CAD/PAD subgroup are thought to be largely unrelated to differences in the effect of edoxaban, but attributable to the differences in baseline intrinsic risks instead. Nonetheless, these differences warrant further investigation. Baseline characteristics n (%) or Mean ± SDPatients with CAD and/or PADPatients without CAD and/or PADTotal (N = 2956)Edoxaban 60 mg (n = 2044)Edoxaban 30 mg (n = 915)Total (N = 10,133)Edoxaban 60 mg (n = 7947)Edoxaban 30 (n = 2186)Male2115 (71.5)1541 (75.4)574 (62.7)5315 (52.5)4520 (56.9)795 (36.4)Age, years75.3 ± 8.573.4 ± 8.279.4 ± 7.673.1 ± 9.771.4 ± 9.379.6 ± 8.1Body mass index, kg/m²28.1 ± 4.728.6 ± 4.727.0 ± 4.728.1 ± 5.228.6 ± 5.226.3 ± 5.1eGFR,* mL/min/1.73m²69.3 ± 28.378.2 ± 27.450.7 ± 19.875.7 ± 30.983.2 ± 29.650.1 ± 19.5(calc.)CHA2DS2-VASc3.5 ± 1.43.3 ± 1.44.0 ± 1.43.0 ± 1.42.8 ± 1.33.7 ± 1.2(calc.) mod. HAS-BLED†2.9 ± 1.12.8 ± 1.13.3 ± 1.12.4 ± 1.12.3 ± 1.12.8 ± 1.0Frailty‡391 (13.2)159 (7.8)232 (25.4)1001 (9.9)453 (5.7)548 (25.1)Data are presented as mean ± standard deviation for continuous variables or n (%) for categorical variables. *Glomerular filtration rate (GFR) was estimated by Cockcroft-Gault formula. †Not including labile international normalised ratio. ‡It was left to the physician"s discretion to categorise a patient as frail.Abstract Figure. One-year outcomes