Baseline characteristics
| Treatment group, N (%) | Warfarin 2.5 mg | Dabigatran 110 mg | Dabigatran 150 mg | p Value |
|---|---|---|---|---|
| Characteristics | ||||
| Number of patients | 49640 | 1612 | 1114 | |
| Age, mean (SD) (years) | 73.5 (±10.0) | 79.6 (±8.3) | 67.9 (±8.15) | |
| Age 65–74 years | 16800 (33.8) | 278 (17.3) | 594 (53.3) | <0.001 |
| Age ≥75 years | 24487 (49.3) | 1245 (77.2) | 225 (20.2) | <0.001 |
| Female | 19380 (39.0) | 850 (52.7) | 409 (36.7) | <0.001 |
| Male | 30280 (61.0) | 762 (47.3) | 705 (63.3) | <0.001 |
| Comorbidity | ||||
| Heart failure | 8623 (17.4) | 286 (17.7) | 84 (7.5) | <0.001 |
| Hypertension | 27838 (56.1) | 834 (51.7) | 501 (44.9) | <0.001 |
| Diabetes mellitus | 8276 (16.7) | 241 (15.0) | 153 (13.7) | 0.007 |
| Previous thromboembolism | 3605 (7.3) | 136 (8.4) | 66 (5.9) | 0.04 |
| Vascular disease | 6928 (14.0) | 265 (16.4) | 113 (10.1) | <0.001 |
| Alcohol | 1723 (3.5) | 61 (3.8) | 50 (4.5) | 0.15 |
| Liver | 690 (1.4) | 31 (1.9) | 17 (1.5) | 0.19 |
| Kidney disease | 3341 (6.7) | 96 (6.0) | 36 (3.2) | <0.001 |
| Previous bleeding | 5171 (10.4) | 209 (13.0) | 78 (7.0) | <0.001 |
| Previous VKA use* | 45403 (91.5) | 782 (48.5) | 349 (31.3) | <0.001 |
| No previous VKA use | 4237 (8.5) | 830 (51.5) | 765 (68.7) | <0.001 |
| Concomitant therapy | ||||
| Digoxin | 17047 (34.3) | 488 (30.3) | 207 (18.6) | <0.001 |
| Amiodarone | 2310 (4.7) | 56 (3.5) | 36 (3.2) | 0.008 |
| Class 1C AA† | 979 (2.0) | 19 (1.2) | 31 (2.8) | 0.01 |
| Sotalol | 967 (2.0) | 27 (1.7) | 26 (2.3) | 0.47 |
| β-Blockers | 31133 (62.7) | 808 (50.1) | 554 (49.7) | <0.001 |
| Non-dihydropyridine CCBs‡ | 4215 (8.5) | 163 (10.1) | 56 (5.0) | <0.001 |
| NSAIDs | 7567 (15.2) | 298 (18.5) | 236 (21.2) | <0.001 |
| Aspirin | 14853 (29.9) | 658 (40.8) | 435 (39.1) | <0.001 |
| CHADS2§ | ||||
| Low (score 0) | 8761 (17.7) | 141 (8.8) | 421 (37.8) | <0.001 |
| Intermediate (score 1) | 17078 (34.4) | 567 (35.2) | 407 (36.5) | <0.001 |
| High (score 2–6) | 23801 (48.0) | 904 (56.0) | 286 (25.7) | <0.001 |
| Mean score (SD) | 1.5 (±1.1) | 1.8 (±1.1) | 1.0 (±1.0) | <0.001 |
| CHA2DS2-VASc¶ | ||||
| Low (score 0) | 2226 (4.5) | 24 (1.5) | 99 (8.9) | <0.001 |
| Intermediate (score 1) | 6405 (12.9) | 82 (5.4) | 262 (23.5) | <0.001 |
| High (score 2–6) | 41009 (82.6) | 1506 (93.4) | 753 (67.6) | <0.001 |
| Mean score (SD) | 2.9 (±1.5) | 3.4 (±1.4) | 2.2 (±1.3) | <0.001 |
| HAS-BLED** | ||||
| Low (score 0) | 15033 (30.3) | 344 (21.4) | 404 (36.3) | <0.001 |
| Intermediate (score 1) | 18569 (37.4) | 626 (38.8) | 418 (37.5) | <0.001 |
| High (score 2–6) | 16038 (32.3) | 642 (39.8) | 292 (26.2) | <0.001 |
| Mean score (SD) | 2.1 (±1.0) | 2.3 (±1.0) | 1.86 (±1.0) | <0.001 |
*Previous VKA use: prescription claims of warfarin from 0 to 180 days prior to baseline stratification.
†Class 1C AA:drug coded as ATC ‘C01B’.
‡Non-dihydropyridine CCBs: drugs coded as ‘C08DA’.
§CHADS2: congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke/transient ischaemic attack.
¶CHA2DS2–VASc: CHADS2, adding vascular disease, age 65–75 and female sex.
**HAS-BLED: hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalised ratio(left out due to lack of information, as carried out previously), elderly (>65 years), drugs/alcohol concomitantly.
NSAIDs, non-steroidal anti-inflammatory drugs; VKA, vitamin K antagonist.