Baseline characteristics of the biomarkers substudy cohort
Aixaban group n=2473 | Warfarin group n=2377 | Total substudy cohort n=4850 | |
Age at consent date, median (Q1, Q3) | 70.0 (63.0, 76.0) | 70.0 (62.0, 76.0) | 70.0 (63.0, 76.0) |
Sex, female | 827 (33.4%) | 827 (34.8%) | 1654 (34.1%) |
Sex, male | 1646 (66.6%) | 1550 (65.2%) | 3196 (65.9%) |
AF, paroxysmal | 386 (15.6%) | 400 (16.8%) | 786 (16.2%) |
Renal impairment, moderate/severe | 364 (14.8%) | 355 (15.0%) | 719 (14.9%) |
Risk factors | |||
Congestive HF/LVEF ≤40% | 872 (35.3%) | 873 (36.7%) | 1745 (36.0%) |
Age≥75 years | 737 (29.8%) | 714 (30.0%) | 1451 (29.9%) |
Hypertension | 2144 (86.7%) | 2091 (88.0%) | 4235 (87.3%) |
Diabetes mellitus | 604 (24.4%) | 604 (25.4%) | 1208 (24.9%) |
Prior stroke/SE/TIA | 431 (17.4%) | 462 (19.4%) | 893 (18.4%) |
Prior MI | 351 (14.2%) | 313 (13.2%) | 664 (13.7%) |
PAD | 119 (4.8%) | 110 (4.6%) | 229 (4.7%) |
CHA2DS2-VASc score | |||
0–1 | 237 (9.6%) | 192 (8.1%) | 429 (8.8%) |
2 | 535 (21.6%) | 496 (20.9%) | 1031 (21.3%) |
3 | 641 (25.9%) | 652 (27.4%) | 1293 (26.7%) |
4 | 539 (21.8%) | 519 (21.8%) | 1058 (21.8%) |
≥5 | 521 (21.1%) | 518 (21.8%) | 1039 (21.4%) |
HAS-BLED score | |||
0–1 | 1393 (56.3%) | 1331 (56.0%) | 2724 (56.2%) |
2 | 776 (31.4%) | 748 (31.5%) | 1524 (31.4%) |
≥3 | 304 (12.3%) | 298 (12.5%) | 602 (12.4%) |
Medical treatment before randomisation | |||
Aspirin | 750 (30.3%) | 674 (28.4%) | 1424 (29.4%) |
Warfarin | 1450 (58.8%) | 1444 (60.9%) | 2894 (59.8%) |
Biomarkers at baseline | |||
F1+2 (pmol/L), median (Q1, Q3) (n) | 90.2 (56.5, 149.0) (2463) | 88.9 (55.5, 146.0) (2365) | 89.5 (56.1, 148.0) (4828) |
D-dimer (µg/L), median (Q1, Q3) (n) | 462.0 (295.5, 752.0) (2464) | 452.0 (291.0, 760.0) (2366) | 456.0 (294.0, 754.0) (4830) |
sCD40L (µg/L), median (Q1, Q3) (n) | 0.56 (0.27, 1.00) (2463) | 0.55 (0.28, 1.10) (2366) | 0.55 (0.27, 1.10) (4829) |
vWF antigen (kIE/L), median (Q1, Q3) (n) | 1.41 (0.99, 1.87) (2461) | 1.42 (0.99, 1.88) (2364) | 1.42 (0.99, 1.88) (4825) |
N (%) are presented if not stated otherwise.
AF, atrial fibrillation; HF, heart failure; LVEF, left ventricular ejection fraction; MI, myocardial infarction; PAD, peripheral arterial occlusive disease; SE, systemic embolism; TIA, transient ischaemic attack.