| Characteristic | Cohort outcome bleed | Cohort outcome stroke | ||||||
|---|---|---|---|---|---|---|---|---|
| NOAC‐users (n = 1247) | VKA‐users (n = 13 177) | Aspirin‐users (n = 15 551) | Mixed‐users (n = 443) | NOAC (n = 1128) | VKA (n = 12 445) | Aspirin (n = 15 471) | Mixed use (n = 402) | |
| Follow‐up (years, SD) | 1.0 (0.6) | 2.7 (1.9) | 2.9 (1.9) | 2.9 (2.0) | 0.9 (0.6) | 2.7 (1.9) | 2.9 (1.9) | 3.0 (2.0) |
| Number of women | 566 (45.4%) | 6073 (46.1%) | 7753 (49.9%) | 159 (35.9%) | 501 (44.4%) | 5683 (45.7%) | 7665 (49.5%) | 142 (35.3%) |
| Age | ||||||||
| Mean age at index date (years, SD) | 72.4 (12.6) | 71.9 (11.9) | 73.5 (12.7) | 72.2 (10.6) | 72.0 (12.8) | 71.7 (12.0) | 73.4 (12.7) | 71.8 (10.5) |
| 18–49 years | 59 (4.7%) | 663 (5.0%) | 654 (4.21%) | 13 (2.9%) | 54 (4.8%) | 651 (5.2%) | 661 (4.3%) | 13 (3.2%) |
| 50–59 years | 155 (12.4%) | 1263 (9.6%) | 1421 (9.14%) | 37 (8.4%) | 148 (13.1%) | 1231 (9.9%) | 1428 (9.2%) | 35 (8.7%) |
| 60–69 years | 252 (20.2%) | 22 943 (22.3) | 359 (23.1%) | 117 (26.4%) | 237 (21.0%) | 2788 (22.4%) | 3589 (23.2)% | 110 (27.4%) |
| 70–79 years | 401 (32.2%) | 4498 (34.1%) | 4259 (27.4%) | 160 (36.1%) | 350 (31.0%) | 4221 (33.9%) | 4238 (27.4%) | 143 (35.6%) |
| 80+ years | 380 (30.5%) | 3810 (28.9%) | 5627 (36.2%) | 116 (26.2%) | 339 (30.1%) | 3554 (28.6%) | 5555 (35.9%) | 101 (25.1%) |
| BMI | ||||||||
| Mean BMI at index date (SD) | 28.0 (6.2) | 28.7 (6.3) | 27.8 (6.2) | 28.9 (6.5) | 28.0 (6.2) | 28.8 (6.4) | 27.8 (6.2) | 29.0 (6.6) |
| < 20 kg m–2 | 77 (6.2%) | 522 (4.0%) | 925 (5.95%) | 20 (4.5%) | 70 (6.2%) | 482 (3.9%) | 926 (6.0%) | 17 (4.2%) |
| 20–25 kg m–2 | 312 (25.0%) | 3056 (23.2%) | 3984 (25.6%) | 94 (21.2%) | 285 (25.3%) | 2886 (23.2%) | 3955 (25.6%) | 83 (20.7%) |
| 25–30 kg m–2 | 403 (32.3%) | 4468 (33.9%) | 5149 (33.1%) | 151 (34.1%) | 364 (32.3%) | 4200 (33.8%) | 5134 (33.2%) | 138 (34.3%) |
| 30–35 kg m–2 | 243 (19.5%) | 2570 (19.5%) | 2668 (17.2%) | 90 (20.3%) | 217 (19.2%) | 2463 (19.8%) | 2664 (17.2%) | 81 (20.2%) |
| >35 kg m–2 | 136 (10.9%) | 1747 (13.3%) | 1617 (10.4%) | 59 (13.3%) | 129 (11.4%) | 1680 (13.5%) | 1619 (10.5%) | 56 (13.9%) |
| Missing | 76 (6.1%) | 814 (6.2%) | 1208 (7.8%) | 29 (6.5%) | 63 (5.6%) | 734 (5.9%) | 1173 (7.58%) | 27 (6.7%) |
| Smoking status | ||||||||
| Never | 545 (43.7%) | 5483 (41.6%) | 6856 (44.1%) | 168 (37.9%) | 493 (43.7%) | 5160 (41.5%) | 6797 (43.9%) | 154 (38.3%) |
| Current | 97 (7.8%) | 1191 (9.0%) | 1493 (9.6%) | 51 (11.5%) | 93 (8.2%) | 1124 (9.0%) | 1495 (9.7%) | 44 (11.0%) |
| Ex | 598 (48.0%) | 6440 (48.9%) | 7126 (45.8%) | 222 (50.1%) | 537 (47.6%) | 6106 (49.1%) | 7105 (45.9%) | 202 (50.3%) |
| Missing | 7 (0.6%) | 63 (0.5%) | 76 (0.5%) | <5 | 5 (0.4%) | 55 (0.4%) | 74 (0.5%) | <5 |
| Alcohol | ||||||||
| Yes | 869 (69.7%) | 9196 (69.8%) | 10 650 (68.5%) | 305 (68.8%) | 795 (70.5%) | 8755 (70.4%) | 10 628 (68.7%) | 277 (68.9%) |
| No | 269 (21.6) | 3034 (23.0%) | 3646 (23.4%) | 100 (22.6%) | 240 (21.3%) | 2835 (22.8%) | 3612 (23.4%) | 89 (22.1%) |
| Missing | 109 (8.7%) | 947 (7.2%) | 1255 (8.1%) | 38 (8.6%) | 93 (8.2%) | 855 (6.9%) | 1231 (8.0%) | 36 (9.0%) |
| CHA 2 DS 2 ‐VASc score | ||||||||
| Mean (SD) | 2.6 (1.5) | 2.6 (1.5) | 2.5 (1.5) | 2.6 (1.4) | 2.4 (1.5%) | 2.5 (1.5%) | 2.5 (1.4%) | 2.5 (1.4%) |
| Low | 564 (45.2%) | 6029 (45.8%) | 7062 (45.4%) | 219 (49.4%) | 525 (46.5%) | 5790 (46.5%) | 7135 (46.1%) | 205 (51.0%) |
| Medium | 319 (25.6%) | 3294 (25.0%) | 4312 (27.7%) | 101 (22.8%) | 310 (27.5%) | 3260 (26.2%) | 4341 (28.1%) | 97 (24.1%) |
| High | 364 (29.2%) | 3854 (29.2%) | 4177 (26.9%) | 123 (27.8%) | 293 (26.0%) | 3395 (27.3%) | 3995 (25.8%) | 100 (24.9%) |
| History of disease ever before | ||||||||
| Acute renal failure | 7 (0.6%) | 60 (0.5%) | 110 (0.7%) | <5 | 5 (0.4%) | 58 (0.5%) | 114 (0.7%) | <5 |
| Cerebrovascular disease | 215 (17.2%) | 1665 (12.6%) | 814 (5.2%) | 69 (15.6%) | 69 (6.1%) | 624 (5.0%) | 365 (2.4%) | 21 (5.2%) |
| Chronic renal failure | 6 (0.5%) | 150 (1.1%) | 150 (1.0%) | <5 | 6 (0.5%) | 134 (1.0%) | 147 (1.0%) | <5 |
| Congestive heart failure | 90 (7.2%) | 1333 (10.1%) | 906 (5.8%) | 66 (14.9%) | 84 (7.5%) | 1297 (10.4%) | 890 (5.8%) | 63 (15.7%) |
| Gastritis | 74 (5.9%) | 768 (5.8%) | 866 (5.6%) | 16 (3.6%) | 67 (5.9%) | 780 (6.3%) | 892 (5.8%) | 17 (4.2%) |
| GI‐bleed | <5 | <5 | <5 | <5 | 32 (2.8%) | 328 (2.6%) | 380 (2.5%) | 6 (1.5%) |
| Hypertension | 675 (54.1%) | 7027 (53.3%) | 7718 (49.6%) | 227 (5.2%) | 604 (53.6%) | 6600 (53.0%) | 7642 (49.4%) | 205 (51.0%) |
| Liver disease | 2 (0.2%) | 15 (0.1%) | 29 (0.2%) | 1 (0.2%) | 2 (0.2%) | 14 (0.1%) | 34 (0.2%) | 0 (0.0%) |
| Cancer | 11 (0.9%) | 120 (0.9%) | 114 (0.7%) | 4 (0.9%) | 15 (1.3%) | 118 (1.0%) | 118 (0.8%) | 4 (1.0%) |
| Peripheral artery disease | 64 (5.1%) | 660 (5.0%) | 612 (3.9%) | 26 (5.9%) | 61 (5.4%) | 623 (5.0%) | 613 (4.0%) | 24 (6.0%) |
| Ischaemic heart disease | 103 (8.3%) | 1343 (10.2%) | 1398 (9.0%) | 111 (25.1%) | 87 (7.7%) | 1255 (10.1%) | 1374 (8.9%) | 105 (26.1%) |
| History of medication use (< 6 months before index date) | ||||||||
| Antiarrhythmic drugs | 78 (6.3%) | 866 (6.6%) | 664 (4.3%) | 13 (2.9%) | 75 (6.7%) | 845 (6.8%) | 655 (4.2%) | 12 (3.0%) |
| Anticoagulant drugs | 16 (1.3%) | 202 (1.5%) | 63 (0.4%) | <5 | 16 (1.2%) | 202 (1.5%) | 63 (0.4%) | <5 |
| Antidiabetic drugs | 93 (7.5%) | 1000 (7.6%) | 876 (5.6%) | 36 (8.1%) | 82 (7.3%) | 952 (7.7%) | 852 (5.5%) | 32 (8.0%) |
| Antihypertensive drugs | 329 (26.3%) | 3690 (28.0%) | 3411 (21.9%) | 102 (23.0%) | 292 (25.9%) | 3480 (28.0%) | 3416 (22.1%) | 98 (24.4%) |
| Antiplatelet drugs | 9 (0.7%) | 190 (1.4%) | 90 (0.6%) | <5 | 4 (0.4%) | 125 (1.0%) | 63 (0.4%) | <5 |
| Insulin | 17 (1.4%) | 203 (1.5%) | 160 (1.0%) | 10 (2.3%) | 15 (1.3%) | 187 (1.5%) | 156 (1.0%) | 9 (2.2%) |
| NSAID's | 140 (11/2%) | 1556 (11.8%) | 2066 (13.3%) | 60 (13.5%) | 123 (10.9%) | 1505 (12.1%) | 2067 (13.4%) | 55 (13.7%) |
| SSRI's | 90 (7.2%) | 761 (5.8%) | 1018 (6.5%) | 17 (3.8%) | 80 (7.1%) | 704 (5.7%) | 1005 (6.5%) | 15 (3.7%) |
| Statins | 371 (29.8%) | 3878 (29.4%) | 3229 (20.8%) | 110 (24.8%) | 301 (26.7%) | 3443 (27.7%) | 3152 (20.4%) | 100 (24.9%) |
| Glucocorticoids | 121 (9.7%) | 1297 (9.8%) | 1226 (7.9%) | 32 (7.2%) | 118 (10.5%) | 1245 (10.0%) | 1235 (8.0%) | 29 (7.2%) |
| History of medication use (<3 months before index date) | ||||||||
| H2 receptor‐antagonists | 30 (2.4%) | 291 (2.2%) | 291 (1.9%) | 11 (2.5%) | 22 (2.0%) | 289 (2.3%) | 282 (1.8%) | 12 (3.0%) |
| PPI's | 329 (26.4%) | 3118 (23.7%) | 3327 (21.4%) | 81 (18.3%) | 305 (27.0%) | 3049 (24.5%) | 3401 (22.0%) | 75 (18.7%) |
NOAC, nonvitamin K antagonist oral anticoagulant; VKA, vitamin K antagonist; SD, standard deviation; BMI, body mass index; NSAIDs, non‐steroidal anti‐inflammatory drugs; SSRI's, selective serotonin reuptake inhibitors; H2, histamine 2; PPI's, proton pump inhibitors, GI, gastrointestinal.