Baseline characteristics of patients with no bleeding, non-major bleeding and major bleeding events
| No bleeding | Non-major bleeding* | Major bleeding† | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Characteristic | Overall (N=15 244) | Apixaban (N=7887) | Warfarin (N=7357) | Overall (N=2204) | Apixaban (N=918) | Warfarin (N=1286) | Overall (N=692) | Apixaban (N=283) | Warfarin (N=409) |
| Age, median (25th, 75th), years | 70 (62, 76) | 70 (62, 76) | 69 (62, 76) | 72 (65, 77) | 72 (65, 77) | 72 (65, 77) | 74 (67, 79) | 73 (67, 78) | 74 (68, 79) |
| Female sex, n (%) | 5344 (35.1) | 2800 (35.5) | 2544 (34.6) | 818 (37.1) | 333 (36.3) | 485 (37.7) | 231 (33.4) | 87 (30.7) | 144 (35.2) |
| Region, n (%) | |||||||||
| North America | 3631 (23.8) | 1892 (24.0) | 1739 (23.6) | 625 (28.4) | 259 (28.2) | 366 (28.5) | 207 (29.9) | 93 (32.9) | 114 (27.9) |
| Latin America | 2900 (19.0) | 1512 (19.2) | 1388 (18.9) | 424 (19.2) | 176 (19.2) | 248 (19.3) | 136 (19.7) | 51 (18.0) | 85 (20.8) |
| Europe | 6343 (41.6) | 3241 (41.1) | 3102 (42.2) | 747 (33.9) | 319 (34.7) | 428 (33.3) | 223 (32.2) | 97 (34.3) | 126 (30.8) |
| Asia Pacific | 2370 (15.5) | 1242 (15.7) | 1128 (15.3) | 408 (18.5) | 164 (17.9) | 244 (19.0) | 126 (18.2) | 42 (14.8) | 84 (20.5) |
| Weight, median (25th, 75th), kg | 82 (70, 96) | 82 (70, 96) | 82 (70, 96) | 82 (70, 95) | 82 (70, 95) | 81 (69, 96) | 80 (68, 93) | 83 (70, 95) | 78 (67, 92) |
| Prior stroke, TIA, or SE, n (%) | 2912 (19.1) | 1487 (18.9) | 1425 (19.4) | 447 (20.3) | 184 (20.0) | 263 (20.5) | 164 (23.7) | 69 (24.4) | 95 (23.2) |
| Hypertension, n (%)‡ | 13 330 (87.4) | 6890 (87.4) | 6440 (87.5) | 1940 (88.0) | 802 (87.4) | 1138 (88.5) | 589 (85.1) | 240 (84.8) | 349 (85.3) |
| Diabetes, n (%) | 3780 (24.8) | 1943 (24.6) | 1837 (25.0) | 542 (24.6) | 230 (25.1) | 312 (24.3) | 204 (29.5) | 103 (36.4) | 101 (24.7) |
| HF or reduced LVEF | – | – | – | – | – | – | – | – | – |
| Coronary artery disease, n (%) | 5048 (33.1) | 2619 (33.2) | 2429 (33.1) | 752 (34.1) | 319 (34.7) | 433 (33.7) | 221 (31.9) | 101 (35.7) | 120 (29.3) |
| PAD, n (%) | 720 (4.8) | 362 (4.6) | 358 (4.9) | 116 (5.3) | 58 (6.4) | 58 (4.6) | 46 (6.7) | 21 (7.5) | 25 (6.2) |
| CHADS2 score, mean (SD) | 2.1 (1.10) | 2.1 (1.09) | 2.1 (1.11) | 2.2 (1.12) | 2.2 (1.13) | 2.2 (1.11) | 2.4 (1.18) | 2.4 (1.15) | 2.3 (1.20) |
| CHA2DS2-VASc score, mean (SD) | 3.4 (1.51) | 3.4 (1.51) | 3.4 (1.50) | 3.6 (1.49) | 3.6 (1.53) | 3.6 (1.47) | 3.8 (1.51) | 3.9 (1.44) | 3.8 (1.56) |
| HAS-BLED score, mean (SD) | 1.7 (1.04) | 1.7 (1.04) | 1.7 (1.04) | 2.0 (1.07) | 2.0 (1.06) | 2.0 (1.08) | 2.1 (1.03) | 2.1 (1.03) | 2.0 (1.03) |
| Prior use of VKA for >30 days, n (%) | 8689 (57.0) | 4492 (57.0) | 4197 (57.0) | 1283 (58.2) | 539 (58.7) | 744 (57.9) | 404 (58.4) | 165 (58.3) | 239 (58.4) |
| Medications at randomisation, n (%) | |||||||||
| Amiodarone | 1724 (11.5) | 882 (11.4) | 842 (11.6) | 254 (11.7) | 95 (10.6) | 159 (12.5) | 69 (10.2) | 28 (10.0) | 41 (10.3) |
| Aspirin | 4577 (30.0) | 2407 (30.5) | 2170 (29.5) | 779 (35.3) | 332 (36.2) | 447 (34.8) | 252 (36.4) | 107 (37.8) | 145 (35.5) |
| Clopidogrel | 264 (1.7) | 142 (1.8) | 122 (1.7) | 48 (2.2) | 16 (1.7) | 32 (2.5) | 25 (3.6) | 11 (3.9) | 14 (3.4) |
| NSAIDs | 1172 (7.8) | 622 (8.0) | 550 (7.6) | 268 (12.4) | 97 (10.8) | 171 (13.4) | 78 (11.5) | 32 (11.4) | 46 (11.6) |
| Gastric antacid drugs | 2703 (18.0) | 1422 (18.3) | 1281 (17.7) | 461 (21.2) | 177 (19.8) | 284 (22.3) | 172 (25.3) | 76 (27.0) | 96 (24.1) |
| Renal function, n (%) | |||||||||
| Normal (80 mL/min) | 6491 (42.6) | 3340 (42.3) | 3151 (42.8) | 813 (36.9) | 325 (35.4) | 488 (37.9) | 192 (27.7) | 85 (30.0) | 107 (26.2) |
| Mild impairment (>50–80 mL/min) | 6286 (41.2) | 3261 (41.3) | 3025 (41.1) | 975 (44.2) | 414 (45.1) | 561 (43.6) | 304 (43.9) | 132 (46.6) | 172 (42.1) |
| Moderate impairment (>30–50 mL/min) | 2192 (14.4) | 1139 (14.4) | 1053 (14.3) | 372 (16.9) | 158 (17.2) | 214 (16.6) | 173 (25.0) | 60 (21.2) | 113 (27.6) |
| Severe impairment (≤30 mL/min) | 209 (1.4) | 112 (1.4) | 97 (1.3) | 37 (1.7) | 18 (2.0) | 19 (1.5) | 22 (3.2) | 6 (2.1) | 16 (3.9) |
| Haemoglobin, median (25th, 75th), g/dL | 14.3 (13.2, 15.3) | 14.3 (13.2, 15.3) | 14.3 (13.3, 15.3) | 14.1 (13.0, 15.1) | 14.1 (13.0, 15.1) | 14.1 (13.0, 15.0) | 13.8 (12.7, 14.9) | 13.9 (12.6, 14.7) | 13.8 (12.7, 14.9) |
| History of anaemia, n (%) | 935 (6.1) | 517 (6.6) | 418 (5.7) | 223 (10.1) | 92 (10.0) | 131 (10.2) | 85 (12.3) | 40 (14.1) | 45 (11.0) |
*Includes all patients where the first bleeding event was ISTH clinically relevant non-major or minor bleeding.
†Includes all patients where the first bleeding event was ISTH major bleeding.
‡Pharmacologically-treated hypertension.
CHAD2DS2-VASC, Congestive heart failure, Hypertension, Age ≥75 years, Diabetes Mellitus , Stroke/TIA/SE, Vascular disease (prior MI, PAD, or aortic plaque); CHADS2, Congestive Heart Failure, Hypertension, Age ≥75 Years, Diabetes Mellitus [1 point for presence of each], and Stroke/TIA [2 points]HAS-BLED, Hypertension, Abnormal renal and liver function, Stroke, Bleeding tendency/predisposition, Labile INRs (if on warfarin).
Elderly, Drugs or alcohol; HF, heart failure; ISTH, International Society on Thrombosis and Haemostasis; LVEF, left ventricular ejection fraction; NSAID, non-steroidal anti-inflammatory drug; PAD, peripheral artery disease; SD, standard deviation; TIA ,transient ischemic attack; VKA, vitamin K antagonist.