Table 1 Baseline demographics and clinical characteristics of patients included in ETNA-AF-Europe
Characteristic | Total | Edoxaban 60 mg OD | Edoxaban 30 mg OD |
|---|---|---|---|
Patients, N (%) | 13,638 (100) | 10,444 (76.6) | 3194 (23.4) |
Male, % | 56.6 | 60.6 | 43.5 |
Age, years, mean (SD) | 73.6 (9.52) | 71.8 (9.23) | 79.6 (7.87) |
By age sub-groups, % | |||
< 65 years | 15.4 | 18.8 | 4.1 |
65–74 years | 33.7 | 38.5 | 18.0 |
75–84 years | 40.3 | 37.3 | 50.4 |
≥ 85 years | 10.6 | 5.4 | 27.5 |
Body weight, kg, mean (SD) | 81.0 (17.34) | 83.5 (16.77) | 72.8 (16.63) |
BMI, kg/m2, mean (SD) | 28.1 (5.14) | 28.6 (5.06) | 26.5 (5.07) |
SBP, mmHg, mean (SD) | 133.4 (18.04) | 133.7 (17.90) | 132.6 (18.46) |
DBP, mmHg, mean (SD) | 78.3 (10.90) | 79.0 (10.91) | 76.2 (10.60) |
Current smoking, % | 6.3 | 6.9 | 4.4 |
Alcohol, % | |||
No | 44.8 | 42.0 | 54.0 |
CrCl (reported), mL/min, mean (SD) | 69.4 (24.23) | 75.5 (22.65) | 50.8 (18.90) |
By CrCl subgroups, % | |||
< 15 | 0.6 | 0.7 | 0.2 |
(15, 30) | 1.9 | 0.3 | 6.8 |
(30, 50) | 18.0 | 6.7 | 52.9 |
(50, 80) | 48.2 | 53.6 | 31.6 |
≥ 80 | 31.3 | 38.7 | 8.5 |
Patients with dose reduction criteria, % | |||
Body weight ≤ 60 kg, % | 10.4 | 5.0 | 27.6 |
CrCl 15–50 mL/min, % | 19.9 | 7.0 | 59.7 |
Concomitant use of P-gp inhibitorsa, % | 1.0 | 0.9 | 1.5 |
(calc.) CHADS2, mean (SD) | 1.7 (1.07) | 1.6 (1.05) | 2.1 (1.03) |
(calc.) CHA2DS2-VASc, mean (SD) | 3.1 (1.40) | 2.9 (1.37) | 3.8 (1.26) |
CHASDS2-VASc score = 0, % | 2.3 | 2.8 | 0.3 |
CHASDS2-VASc score = 1, % | 10.3 | 12.6 | 2.5 |
(calc.) HAS-BLED, mean | 2.6 (1.13) | 2.4 (1.11) | 3.0 (1.10) |
Frailtyb, % | |||
Yes | 10.6 | 6.1 | 25.3 |
No | 82.7 | 87.3 | 67.4 |
Not known | 6.7 | 6.6 | 7.3 |
Previous history of CV disease, % | |||
Hypertension | 76.9 | 75.9 | 80.0 |
Congestive heart failure | 5.8 | 4.7 | 9.5 |
Myocardial infarction | 4.3 | 3.7 | 6.2 |
Angina pectoris | 1.5 | 1.3 | 2.1 |
Valvular disease | 17.7 | 16.2 | 22.9 |
Peripheral artery disease | 3.3 | 2.8 | 5.2 |
Previous history of diabetes mellitus, % | 21.9 | 20.5 | 26.7 |
Previous history of stroke and ICH, % | |||
Ischaemic stroke | 5.9 | 5.6 | 6.9 |
Stroke, unknown | 0.6 | 0.5 | 0.8 |
Transient ischaemic attack | 3.3 | 3.2 | 3.7 |
Intracranial haemorrhage | 0.5 | 0.4 | 0.6 |
Previous history of bleeding, % | |||
Any bleeding | 3.1 | 2.5 | 5.2 |
GI bleeding (Major or CRNM) | 0.8 | 0.5 | 1.7 |
Major | 1.0 | 0.8 | 1.6 |
CRNM | 1.0 | 0.8 | 1.8 |
Minor | 1.1 | 0.9 | 1.8 |
Renal disease (including dialysis), % | 27.0 | 19.5 | 51.6 |
Current AF type, % | |||
Paroxysmal | 53.6 | 54.5 | 50.4 |
Persistent | 24.4 | 25.3 | 21.2 |
Long-standing persistent | 2.4 | 2.3 | 2.9 |
Permanent | 19.6 | 17.8 | 25.5 |
Time since first AF diagnosis, months | |||
Mean (SD) | 25.7 (46.88) | 24.9 (47.01) | 28.4 (46.37) |
IQ, Q1–Q3 | 29.3–0.4 | 26.5–0.4 | 37.5–0.6 |
Previous use of AF relevant medication, % | |||
VKA | 16.9 | 16.3 | 18.9 |
NOAC (other) | 8.0 | 6.9 | 11.6 |
Antiarrrhythmics | 5.0 | 5.0 | 4.8 |
Antiplatelet | 15.1 | 14.8 | 16.2 |