Baseline characteristics for ARISTOTLE trial eligible patients by OAC treatment at baseline
| Treatment at baseline | |||
| Baseline characteristics | Apixaban (n=2570) | Rivaroxaban (N=3560) | VKA (N=8005) |
| Female sex, n (%) | 1240 (48.2) | 1599 (44.9) | 3747 (46.8) |
| Age, median (Q1; Q3), years | 76.0 (69.0; 81.0) | 73.0 (65.0; 79.0) | 71.0 (64.0; 77.0) |
| Ethnicity, n (%) | |||
| Caucasian | 1513 (60.8) | 2507 (71.5) | 5296 (67.3) |
| Hispanic/Latino | 70 (2.8) | 199 (5.7) | 666 (8.5) |
| Asian | 859 (34.5) | 722 (20.6) | 1730 (22.0) |
| Afro-Caribbean/mixed/other | 46 (1.8) | 79 (2.3) | 174 (2.2) |
| Body mass index, median (Q1; Q3), kg/m² | 26.2 (23.4; 29.8) | 27.5 (24.4; 31.3) | 27.8 (24.6; 32.0) |
| Systolic blood pressure, median (Q1; Q3), mm Hg | 130.0 (120.0; 142.0) | 132.0 (120.0; 144.0) | 130.0 (120.0; 144.0) |
| Diastolic blood pressure, median (Q1; Q3), mm Hg | 79.0 (70.0; 85.0) | 80.0 (70.0; 86.0) | 80.0 (70.0; 88.0) |
| Pulse, median (Q1; Q3), bpm | 84.0 (70.0; 107.0) | 84.0 (70.0; 105.0) | 84.0 (72.0; 100.0) |
| Type of atrial fibrillation, n (%) | |||
| Permanent | 340 (13.2) | 472 (13.3) | 1398 (17.5) |
| Persistent | 392 (15.3) | 587 (16.5) | 1358 (17.0) |
| Paroxysmal | 895 (34.8) | 1104 (31.0) | 1736 (21.7) |
| New onset (unclassified) | 943 (36.7) | 1397 (39.2) | 3513 (43.9) |
| Care setting specialty at diagnosis, n (%) | |||
| Internal medicine/neurology/geriatrics | 486 (18.9) | 679 (19.1) | 1558 (19.5) |
| Cardiology | 1826 (71.1) | 2439 (68.5) | 5122 (64.0) |
| Primary care/general practice | 258 (10.0) | 442 (12.4) | 1325 (16.6) |
| Care setting location at diagnosis, n (%) | |||
| Hospital | 1190 (46.3) | 1653 (46.4) | 4643 (58.0) |
| Office/anticoagulation clinic/thrombosis centre | 1142 (44.4) | 1582 (44.4) | 2514 (31.4) |
| Emergency room | 238 (9.3) | 325 (9.1) | 848 (10.6) |
| Medical history, n (%) | |||
| Heart failure | 567 (22.1) | 820 (23.0) | 2046 (25.6) |
| Acute coronary syndromes | 227 (8.9) | 336 (9.5) | 798 (10.0) |
| Vascular disease* | 491 (19.3) | 802 (22.8) | 1947 (24.6) |
| Carotid occlusive disease | 90 (3.6) | 97 (2.8) | 176 (2.2) |
| VTE | 53 (2.1) | 108 (3.1) | 260 (3.3) |
| Prior stroke/TIA/SE | 366 (14.4) | 375 (10.6) | 1032 (13.0) |
| Hypertension | 2082 (81.2) | 3020 (84.9) | 6761 (84.7) |
| Hypercholesterolaemia | 1114 (44.3) | 1655 (48.2) | 3506 (46.0) |
| Diabetes | 621 (24.2) | 917 (25.8) | 2219 (27.7) |
| Moderate to severe CKD | 219 (8.8) | 288 (8.4) | 469 (6.3) |
| Current smoker, n (%) | 181 (7.9) | 309 (9.6) | 694 (9.4) |
| AP treatment, n (%) | 372 (14.7) | 539 (15.4) | 1665 (20.8) |
| CHADS2 score, median (Q1; Q3) | 2.0 (1.0; 3.0) | 2.0 (1.0; 2.0) | 2.0 (1.0; 3.0) |
| CHADS2 score 0–1, n (%) | 707 (29.4) | 1124 (33.7) | 2345 (31.5) |
| CHADS2 score 2, n (%) | 1005 (41.8) | 1398 (41.9) | 3198 (43.0) |
| CHADS2 score≥3, n (%) | 690 (28.7) | 815 (24.4) | 1896 (25.5) |
| CHA2DS2-VASc score, median (Q1; Q3) | 4.0 (3.0; 4.0) | 3.0 (2.0; 4.0) | 3.0 (3.0; 4.0) |
| HAS-BLED score†, median (Q1; Q3) | 1.0 (1.0; 2.0) | 1.0 (1.0; 2.0) | 1.0 (1.0; 2.0) |
| GARFIELD-AF mortality score§‡, median (Q1; Q3) | 4.6 (2.9; 7.7) | 4.1 (2.4; 6.9) | 5.0 (3.0; 7.7) |
| GARFIELD-AF stroke score §¶, median (Q1; Q3) | 1.4 (1.0; 1.9) | 1.2 (0.9; 1.7) | 1.5 (1.1; 2.0) |
| GARFIELD-AF bleeding score§**, median (Q1; Q3) | 1.7 (1.2; 2.2) | 1.5 (1.1; 2.0) | 2.1 (1.5; 2.7) |
*Defined as peripheral artery disease and/or coronary artery disease.
†The risk factor ‘labile INRs’ is not included in the HAS-BLED score as it is not collected at baseline. As a result, the maximum HAS-BLED score at baseline is 8 points (not 9).
‡Represents the expected probability of dying within 2 years follow-up.
§The GARFIELD-AF risk scores use different coefficients for NOAC and VKA treatment, leading to higher estimated risk in VKA users versus NOAC users with the same baseline characteristics. The scores are not impacted by the type of NOAC.
¶Represents the expected probability of developing a non-haemorrhagic stroke/SE within 2 years follow-up.
**Represents the expected probability of developing a major bleeding within 2 years follow-up.
AP, antiplatelet; ARISTOTLE, Apixaban for Reduction in Stroke and Other Thromboembolic Events; CKD, chronic kidney disease; GARFIELD, Global Anticoagulant Registry in the Field; HAS-BLED, Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly; NOAC, non-vitamin K oral antagonist; OAC, oral anticoagulation; SE, systemic embolism; TIA, transient ischaemic attack; VKA, vitamin K antagonist; VTE, venous thromboembolism.