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

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

Unmet Clinical Needs in Elderly Patients Receiving Direct Oral Anticoagulants for Stroke Prevention in Non-valvular Atrial Fibrillation

“…Compared with patients aged 65 years or younger, they had 50% lower mean creatinine clearance values and higher CHA 2 DS 2 VASc and HAS-BLED scores. Elderly patients faced more ischemic and haemorrhagic events, with the notable exception of intracranial haemorrhage, at 1-year follow-up[22].Overall, analyses of phase III RCTs and realworld data indicate that DOACs retain their favourable safety and efficacy profile over VKAs in elderly individuals with NVAF and creatinine clearance values of 30-50 mL/min…”