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Table 1 Baseline characteristics of participants by frailty category

From: Clinical outcomes in patients with atrial fibrillation and frailty: insights from the ENGAGE AF-TIMI 48 trial

  Frailty category
  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)
  1. Abbreviations: AF atrial fibrillation, Cr creatinine, SD standard deviation, TIA transient ischaemic attack, VKA vitamin K antagonist
  2. *At randomisation