Table 1 Baseline characteristics of participants by frailty category
| Â | Frailty category | ||||
|---|---|---|---|---|---|
| Â | All | Fit | Pre-fail | Mild-moderate | Severe |
n (%) | 20,867 | 4459 (21.4) | 12,326 (59.1) | 3722 (17.8) | 360 (1.7) |
Mean frailty index (SD) | 0.18 (0.07) | 0.09 (0.02) | 0.18 (0.03) | 0.28 (0.03) | 0.40 (0.03) |
Demographics | |||||
 Age, n (%) | |||||
  < 60 years | 2748 (13.2) | 739 (16.6) | 1671 (13.6) | 319 (8.6) | 19 (5.3) |
  60–69 years | 5875 (28.2) | 1245 (27.9) | 3583 (29.1) | 979 (26.3) | 68 (18.9) |
  70–79 | 8716 (41.8) | 1795 (40.3) | 5111 (41.5) | 1641 (44.1) | 169 (46.9) |
  80+ years | 3528 (16.9) | 680 (15.3) | 1961 (15.9) | 783 (21.0) | 104 (28.9) |
 Female sex, n (%) | 7940 (38.1) | 1470 (33.0) | 4685 (38.0) | 1619 (43.5) | 166 (46.1) |
 Region, n (%) | |||||
  North America | 4654 (22.3) | 721 (16.2) | 2639 (21.4) | 1153 (31.0) | 141 (39.2) |
  Latin America | 2647 (12.7) | 898 (20.1) | 1484 (12.0) | 252 (6.8) | 13 (3.6) |
  Western Europe | 3091 (14.8) | 743 (16.7) | 1804 (14.6) | 492 (13.2) | 52 (14.4) |
  Eastern Europe | 7105 (34.0) | 1143 (25.6) | 4392 (35.6) | 1442 (38.7) | 128 (35.6) |
  Asia-Pacific and South Africa | 3370 (16.1) | 954 (21.4) | 2007 (16.3) | 383 (10.3) | 26 (7.2) |
Clinical | |||||
 Paroxysmal AF, n (%) | 5311 (25.5) | 1073 (24.1) | 3195 (25.9) | 958 (25.8) | 85 (23.6) |
 Qualifying risk factor, n (%) | |||||
  Age ≥ 75 | 8356 (40.0) | 1799 (40.3) | 4693 (38.1) | 1669 (44.8) | 195 (54.2) |
  Prior stroke or TIA | 5909 (28.3) | 988 (22.2) | 3345 (27.1) | 1398 (37.6) | 178 (49.4) |
  Congestive heart failure | 11,967 (57.3) | 1993 (44.7) | 7075 (57.4) | 2601 (69.9) | 298 (82.8) |
  Diabetes mellitus | 7546 (36.2) | 825 (18.5) | 4478 (36.3) | 1989 (53.4) | 254 (70.6) |
  Hypertension | 19,454 (93.2) | 4083 (91.6) | 11,518 (93.4) | 3506 (94.2) | 347 (96.4) |
 CHADS2 score | |||||
  Mean score (SD) | 2.83 (0.98) | 2.39 (0.67) | 2.80 (0.91) | 3.37 (1.11) | 4.03 (1.19) |
  ≤ 3, n (%) | 16,167 (77.5) | 4099 (91.9) | 9739 (79.0) | 2193 (58.9) | 136 (37.8) |
  4–6, n (%) | 4699 (22.5) | 360 (8.1) | 2587 (21.0) | 1528 (41.1) | 224 (62.2) |
 Dose reduction*, n (%) | 5302 (25.4) | 1020 (22.9) | 2885 (23.4) | 1237 (33.2) | 160 (44.4) |
  Cr clearance ≤ 50 ml/min | 3975 (19.2) | 613 (13.9) | 2119 (17.3) | 1083 (29.5) | 160 (45.5) |
  Weight ≤ 60 kg | 2063 (9.9) | 524 (11.8) | 1182 (9.6) | 341 (9.2) | 16 (4.4) |
  Use of verapamil or qunidine | 701 (3.4) | 183 (4.1) | 394 (3.2) | 116 (3.1) | 8 (2.2) |
 Previous VKA for ≥ 60 days, n (%) | 12,305 (59.0) | 2509 (56.3) | 7241 (58.7) | 2303 (61.9) | 252 (70.0) |
Medication at time of randomisation, n (%) | |||||
 Aspirin | 6121 (29.3) | 1107 (24.8) | 3650 (29.6) | 1234 (33.2) | 130 (36.1) |
 Thienopyridine | 480 (2.3) | 62 (1.4) | 264 (2.1) | 140 (3.8) | 14 (3.9) |
 Amiodarone | 2441 (11.7) | 501 (11.2) | 1397 (11.3) | 489 (13.1) | 54 (15.0) |
 Digoxin or digitalis preparation | 6271 (30.1) | 1269 (28.5) | 3713 (30.1) | 1172 (31.5) | 117 (32.5) |
Treatment allocation, n (%) | |||||
 Warfarin | 6957 (33.3) | 1479 (33.2) | 4130 (33.5) | 1230 (33.0) | 118 (32.8) |
 Edoxaban 30 mg | 6956 (33.3) | 1473 (33.0) | 4122 (33.4) | 1247 (33.5) | 114 (31.7) |
 Edoxaban 60 mg | 6954 (33.3) | 1507 (33.8) | 4074 (33.1) | 1245 (33.4) | 128 (35.6) |