Baseline demographic details of patients recruited in the study
| Parameter | Dabigatran group | VKA group | Total | Standardised difference |
| Eligible patients | 591 | 343 | 934 | |
| Sex, n (%) | ||||
| Female | 228 (38.6) | 106 (30.9) | 334 (35.8) | 0.1617 |
| Male | 363 (61.4) | 237 (69.1) | 600 (64.2) | −0.1617 |
| Mean age (years) | 67.3±9.8 | 63.4±10.9 | 65.9±10.4 | 0.3797 |
| Age group, n (%) | ||||
| <65 years | 196 (33.2) | 184 (53.6) | 380 (40.7) | –0.4223 |
| 65–75 years | 256 (43.3) | 101 (29.4) | 357 (38.2) | 0.2914 |
| ≥75 years | 139 (23.5) | 50 (16.9) | 189 (20.2) | 0.1651 |
| Region, n (%) | ||||
| Region 1 | 124 (21.0) | 32 (9.3) | 156 (16.7) | 0.3293 |
| Region 2 | 467 (79.0) | 311 (90.7) | 778 (83.3) | −0.3293 |
| CHA2DS2-VASc stroke risk score, mean±SD | 2.6±1.4 | 2.0±1.6 | 2.4±1.5 | 0.3659 |
| CHA2DS2-VASc stroke risk score class, n (%) | ||||
| Low risk (score=0) | 29 (4.9) | 50 (14.6) | 79 (8.5) | −0.3305 |
| Intermediate risk (score=1) | 78 (13.2) | 106 (30.9) | 184 (19.7) | −0.4372 |
| High risk (score ≥2) | 482 (81.6) | 187 (54.5) | 669 (71.6) | 0.6058 |
| Missing | 2 (0.3) | 0 (0.0) | 2 (0.2) | 0.0824 |
| HAS-BLED bleeding risk score, mean±SD | 1.3±0.9 | 1.1±1.1 | 1.2±0.9 | 0.2624 |
| HAS-BLED bleeding risk score class, n (%) | ||||
| Low risk (score <3) | 540 (91.4) | 306 (89.2) | 846 (90.6) | 0.0729 |
| High risk (score ≥3) | 49 (8.3) | 37 (10.8) | 86 (9.2) | −0.0851 |
| Missing | 2 (0.3) | 0 (0.0) | 2 (0.2) | 0.0824 |
| Creatinine clearance (mL/min), mean±SD | 75.4±29.0 | 73.0±29.2 | 74.6±29.1 | 0.0807 |
| Creatinine clearance class, n (%) | ||||
| <50 mL/min | 66 (11.2) | 42 (12.2) | 108 (11.6) | −0.0335 |
| 50 to <80 mL/min | 210 (35.5) | 78 (22.7) | 288 (30.8) | 0.2844 |
| ≥80 mL/min | 140 (23.7) | 69 (20.1) | 209 (22.4) | 0.0864 |
| Not available | 175 (29.6) | 154 (44.9) | 329 (35.2) | −0.3202 |
| No of patients with at least one prespecified concomitant disease, n (%) | 343 (58.0) | 162 (47.2) | 505 (54.1) | 0.2177 |
| Concomitant diseases, n (%) | ||||
| Hypertension | 224 (37.9) | 89 (25.9) | 313 (33.5) | 0.2586 |
| Hyperlipidaemia | 147 (24.9) | 68 (19.8) | 215 (23.0) | 0.1214 |
| Diabetes mellitus (type 1 or 2) | 91 (15.4) | 34 (9.9) | 125 (13.4) | 0.1655 |
| Congestive heart failure | 52 (8.8) | 31 (9.0) | 83 (8.9) | −0.0084 |
| Stroke | 25 (4.2) | 25 (7.3) | 50 (5.4) | −0.1316 |
| Comorbidities, n (%) | ||||
| Malignancy | 28 (4.7) | 11 (3.2) | 39 (4.2) | 0.0784 |
| GI disease | 31 (5.2) | 18 (5.2) | 49 (5.2) | −0.0001 |
| Concomitant therapies, n (%) | ||||
| P-gp inhibitors | 50 (8.5) | 24 (7.0) | 74 (7.9) | 0.0548 |
| Antithrombotic agent | 56 (9.5) | 68 (19.8) | 124 (13.3) | −0.2959 |
| NSAIDs | 17 (2.9) | 6 (1.7) | 23 (2.5) | 0.0750 |
| Type of hospital or practice, n (%) | ||||
| Public and other | 282 (47.7) | 142 (41.4) | 424 (45.4) | 0.1273 |
| Private | 309 (52.3) | 201 (58.6) | 510 (54.6) | −0.1273 |
GI, gastrointestinal; NSAIDs, non-steroidal anti-inflammatory drugs; P-gp, P-glycoprotein; SD, standardised difference; VKA, vitamin K antagonists.