Table 1.
Baseline clinical characteristics.
| N = 1361 | HAS-BLED | p | ATRIA | p | ORBIT | p | HEMORR 2 HAGES | p | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| score | score | score | score | |||||||||
| 0–2 | ≥3 | <4 | ≥4 | <3 | ≥3 | 0–1 | ≥2 | |||||
| Low risk | High Risk | Low risk | Medium/High risk | Low risk | Medium/High risk | Low risk | Medium/High risk | |||||
| N = 752 | N = 609 | N = 1059 | N = 302 | N = 1042 | N = 319 | N = 343 | N = 1018 | |||||
| Female sex, n (%) | 400 (53.2) | 298 (48.9) | 0.118 | 532 (50.2) | 166 (55) | 0.147 | 529 (50.8) | 150 (47) | 0.490 | 153 (44.6) | 545 (53.5) | 0.004 |
| Age (years), median (IQR) | 75 (68–80) | 78 (73–82) | <0.001 | 75 (69–80) | 79 (75–83) | <0.001 | 75 (69–80) | 80 (76–83) | <0.001 | 70 (64–74) | 79 (74–82) | <0.001 |
| Comorbidities, n (%) | ||||||||||||
| Hypertension | 545 (72.5) | 571 (93.8) | <0.001 | 850 (80.3) | 266 (88.1) | 0.002 | 845 (81.1) | 271 (85) | 0.116 | 208 (60.6) | 908 (89.2) | <0.001 |
| Diabetes mellitus | 171 (22.7) | 192 (31.5) | <0.001 | 267 (25.2) | 96 (31.8) | 0.023 | 254 (24.4) | 109 (34.2) | 0.001 | 68 (19.8) | 295 (29.0) | 0.001 |
| Heart failure | 212 (28.2) | 217 (35.6) | 0.003 | 303 (28.6) | 126 (41.7) | <0.001 | 295 (28.3) | 134 (42.0) | <0.001 | 72 (21) | 357 (35.1) | <0.001 |
| History of stroke/TIA | 32 (4.3) | 225 (36.9) | <0.001 | 185 (17.5) | 72 (23.8) | 0.013 | 174 (16.7) | 83 (26.0) | <0.001 | 10 (2.9) | 247 (24.3) | <0.001 |
| Hepatic impairment | 2 (0.3) | 16 (2.6) | <0.001 | 14 (1.3) | 4 (1.3) | 0.997 | 12 (1.2) | 6 (1.9) | 0.318 | 1 (0.3) | 17 (1.7) | 0.053 |
| Renal impairment | 10 (1.3) | 134 (22.0) | <0.001 | 83 (7.8) | 61 (20.2) | <0.001 | 76 (7.3) | 68 (21.3) | <0.001 | 10 (2.9) | 134 (13.2) | <0.001 |
| Anaemia | 117 (15.6) | 137 (22.5) | 0.001 | 13 (1.2) | 241 (79.8) | <0.001 | 36 (3.5) | 218 (68.3) | <0.001 | 4 (1.2) | 250 (24.6) | <0.001 |
| Coronary artery disease | 95 (12.6) | 160 (26.3) | <0.001 | 181 (17.1) | 74 (24.5) | 0.004 | 157 (15.1) | 98 (30.7) | <0.001 | 47 (13.7) | 208 (20.4) | 0.006 |
| Current smoking habit | 101 (13.4) | 109 (17.9) | 0.023 | 162 (15.3) | 48 (15.9) | 0.800 | 152 (14.6) | 58 (18.2) | 0.120 | 52 (15.2) | 158 (15.5) | 0.873 |
| Current alcohol consumption | 4 (0.5) | 46 (7.6) | <0.001 | 41 (3.9) | 9 (3.0) | 0.468 | 39 (3.7) | 11 (3.4) | 0.807 | 1 (0.3) | 49 (4.8) | <0.001 |
| Concomitant antiplatelet treatment | 27 (3.6) | 216 (35.5) | <0.001 | 178 (16.8) | 65 (21.5) | 0.059 | 139 (13.3) | 104 (32.6) | <0.001 | 9 (2.6) | 234 (23.0) | <0.001 |
| Prior malignant disease | 47 (6.3) | 58 (9.5) | 0.024 | 72 (6.8) | 33 (10.9) | 0.018 | 71 (6.8) | 34 (10.7) | 0.024 | 5 (1.5) | 100 (9.8) | <0.001 |
| Time in therapeutic range (%), median (IQR) | 80 (66–100) | 64 (50–83) | <0.001 | 80 (66–100) | 80 (60–94) | 0.028 | 80 (66–100) | 80 (60–88) | 0.003 | 80 (66–100) | 80 (66–100) | 0.278 |
| TTR <65%, n (%) | 138 (18.4) | 311 (51.1) | <0.001 | 250 (23.6) | 80 (26.5) | 0.302 | 237 (22.7) | 93 (29.2) | 0.019 | 78 (22.7) | 252 (24.8) | 0.452 |
| Thromboembolic risk | ||||||||||||
| CHA2DS2-VASc score, median (IQR) | 3 (2–4) | 5 (4–6) | <0.001 | 4 (3–5) | 5 (4–6) | <0.001 | 4 (3–5) | 5 (4–6) | <0.001 | 3 (2–3) | 4 (4–5) | <0.001 |
CHA2DS2-VASc = cardiac failure or dysfunction, hypertension, age ≥75 [doubled], diabetes, stroke [doubled] – vascular disease, age 65–74 years and sex category [female]; IQR = interquartile range; TIA = transient ischemic attack; TTR = time in therapeutic range.