P4788One-year outcomes of elderly patients with atrial fibrillation: snapshot data from the global noninterventional program on edoxaban treatment in routine clinical practice in atrial fibrillation

EUROPEAN HEART JOURNAL(2019)

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Abstract Background As populations age, prevalence of atrial fibrillation (AF) and ensuing need for oral anticoagulation increase. Benefits and risks of nonvitamin K antagonist oral anticoagulants such as edoxaban in the frail, elderly population with AF in regular clinical care is of special interest. Purpose Data from Global ETNA-AF capturing almost 2ehz745.1164 patients treated with edoxaban in Europe, Japan, and Korea/Taiwan, was analyzed to compare outcomes in patients <75 years, elderly (≥75 years), and very elderly (≥85 years) patients. Methods Global ETNA-AF is a multinational, multicentre, prospective, noninterventional program (EU: NCT02944019, Japan: UMINehz745.116417011, Korea/Taiwan: NCT02951039). Demographics, baseline characteristics, and 1-year outcome data were reported for 19416 patients classified into 3 age categories. Results At 1-year follow-up, rates of major bleeding (including intracranial haemorrhage [ICH]) and ischaemic stroke were generally low. All-cause and CV mortality increased with age; CV mortality was a minor proportion of all-cause mortality in all age groups. Rates of major bleeding and ischaemic stroke increased slightly with age, but to a lesser extent than all-cause and CV mortality. There was no increase in the rate of ICH with age. <75 yrs (N=9725) ≥75 yrs (N=9687) ≥85 yrs (N=2186) Age, median (IQR) 68.0 (63.0, 72.0) 80.0 (77.0, 84.0) 87.0 (86.0, 89.0) Gender, male % 65.8 51.5 41.4 BMI, median (IQR) 25.6 (22.9, 29.0) 24.5 (21.9, 27.5) 23.4 (20.8, 26.1) Weight, median (IQR) kg 71.0 (60.0, 84.5) 62.5 (52.9, 75.0) 55.4 (47.6, 67.0) CHA2DS2-VASc, mean (SD) 2.4 (1.28) 4.1 (1.27) 4.4 (1.34) CrCl [mL/min], median (IQR) 78.4 (63.6, 95.9) 52.0 (41.1, 64.5) 40.3 (32.2, 49.4) Edoxaban 60/30 mg, % 64.0/36.0 34.3/65.7 15.8/84.2 1-year outcome, n (%/year) Major bleeding (ISTH) 57 (0.71) 93 (1.19) 25 (1.53) Intracranial hemorrhage 22 (0.27) 22 (0.28) 3 (0.18) Major GI* bleeding 18 (0.22) 36 (0.46) 16 (0.98) CRNMB** 126 (1.57) 212 (2.73) 56 (3.45) Ischaemic stroke 53 (0.66) 83 (1.06) 23 (1.41) All-cause/CV mortality 95 (1.18)/25 (0.31) 224 (2.86)/55 (0.70) 89 (5.44)/23 (1.41) *Gastrointestinal. **Clinically relevant nonmajor bleeding. Conclusion Global data from this set of unselected patients support the use of edoxaban as a safe and effective treatment in elderly and very elderly patients with AF in regular clinical care. Acknowledgement/Funding Daiichi Sankyo
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