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Table 2 Numbers and rates of outcome events

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

   Frailty category
All Fit Pre-frail Mild-moderate Severe
Primary end points
 Time to the first adjudicated stroke or systemic embolism Warfarin 333 55 185 83 10
1.73 (1.54 - 1.92) 1.29 (0.95 - 1.63) 1.61 (1.38 - 1.84) 2.58 (2.03 - 3.14) 3.40 (1.29 - 5.51)
Edoxaban 30mg 378 56 219 100 3
1.95 (1.76 - 2.15) 1.34 (0.99 - 1.69) 1.90 (1.64 - 2.15) 3.00 (2.41 - 3.59) 1.04 (0.00 - 2.21)
Edoxaban 60mg 286 58 151 71 6
1.47 (1.30 - 1.64) 1.35 (1.00 - 1.70) 1.31 (1.11 - 1.52) 2.13 (1.64 - 2.63) 1.85 (0.37 - 3.34)
 Time to the first adjudicated major bleeding during treatment Warfarin 522 84 298 122 18
2.76 (2.52 - 3.00) 2.01 (1.58 - 2.44) 2.64 (2.34 - 2.95) 3.85 (3.17 - 4.53) 6.39 (3.44 - 9.35)
Edoxaban 30mg 249 35 141 60 13
1.28 (1.12 - 1.44) 0.83 (0.56 - 1.11) 1.22 (1.02 - 1.42) 1.80 (1.34 - 2.25) 4.74 (2.16 - 7.31)
Edoxaban 60mg 414 82 227 93 12
2.17 (1.96 - 2.38) 1.94 (1.52 - 2.36) 2.01 (1.75 - 2.27) 2.86 (2.28 - 3.44) 3.80 (1.65 - 5.95)
Composite net clinical endpoints
 Stroke, systemic embolic event, major bleeding or death Warfarin 1462 205 811 393 53
7.90 (7.50 - 8.31) 4.97 (4.29 - 5.65) 7.34 (6.84 - 7.85) 12.86 (11.59 - 14.14) 19.41 (14.19 - 24.64)
Edoxaban 30mg 1247 185 686 335 41
6.58 (6.22 - 6.95) 4.48 (3.83 - 5.13) 6.06 (5.61 - 6.52) 10.35 ( 9.24 - 11.46) 15.71 (10.90 - 20.52)
Edoxaban 60mg 1321 231 685 361 44
7.06 (6.68 - 7.44) 5.56 (4.84 - 6.27) 6.16 (5.70 - 6.62) 11.51 (10.32 - 12.70) 14.49 (10.21 - 18.77)
 Disabling stroke, life-threatening bleeding, or death Warfarin 981 124 529 285 43
5.07 (4.75 - 5.39) 2.91 (2.39 - 3.42) 4.58 (4.19 - 4.98) 8.79 (7.77 - 9.82) 14.58 (10.22 - 18.93)
Edoxaban 30mg 836 124 448 236 28
4.26 (3.97 - 4.55) 2.93 (2.42 - 3.45) 3.83 (3.47 - 4.18) 6.95 (6.06 - 7.83) 9.69 ( 6.10 - 13.28)
Edoxaban 60mg 882 139 454 259 30
4.52 (4.22 - 4.81) 3.21 (2.68 - 3.74) 3.94 (3.58 - 4.30) 7.76 (6.81 - 8.70) 9.08 ( 5.83 - 12.33)
 Stroke, systemic embolic event, life-threatening bleeding, or death Warfarin 1109 145 603 315 46
5.80 (5.45 - 6.14) 3.43 (2.87 - 3.98) 5.28 (4.86 - 5.70) 9.88 ( 8.79 - 10.98) 15.91 (11.31 - 20.51)
Edoxaban 30mg 999 148 542 280 29
5.16 (4.84 - 5.48) 3.53 (2.96 - 4.10) 4.69 (4.30 - 5.09) 8.42 (7.43 - 9.40) 10.09 ( 6.42 - 13.77)
Edoxaban 60mg 990 168 501 287 34
5.12 (4.80 - 5.43) 3.92 (3.33 - 4.52) 4.38 (3.99 - 4.76) 8.70 (7.70 - 9.71) 10.51 ( 6.98 - 14.04)
 Death Warfarin 837 100 447 252 38
4.27 (3.98 – 4.56) 2.32 (1.86 – 2.77) 3.82 (3.47 – 4.18) 7.62 (6.68 – 8.56) 12.54 (8.56 – 16.53)
Edoxaban 30mg 736 107 387 217 25
3.79 (3.52 – 4.06) 2.51 (2.03 – 2.99) 3.37 (3.04 – 3.71) 6.34 (5.50 – 7.18) 8.46 (5.14 – 11.77)
Edoxaban 60mg 772 121 391 231 29
3.92 (3.64 – 4.19) 2.77 (2.28 – 3.27) 3.38 (3.05 – 3.72) 6.81 (5.93 – 7.68) 8.71 (5.54 – 11.89)
  1. Each cell shows number, and incidence rates per 100 person years (95% confidence interval)