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. Author manuscript; available in PMC: 2022 Jun 1.
Published in final edited form as: Clin Pharmacol Ther. 2021 Jan 19;109(6):1593–1605. doi: 10.1002/cpt.2131

Table 1:

Demographics, AF phenotype and key risk factors at baseline by level of kidney function (glomerular filtration rate; GFR) impairment

GFR (ml/min/1.73m2) ≥90 ≥60-89 ≥45-59 ≥30-44 < 30 p-
value
RELY (n=18,049) N=1,293 N=9,487 N=5,091 N=2,022 N=156
Dabigatran 110 400 (30.9%) 3,209 (33.8%) 1,660 (32.6%) 672 (33.2%) 52 (33.3%)
Dabigatran 150 450 (34.8%) 3,133 (33.0%) 1,710 (33.6%) 708 (35.0%) 57 (36.5%)
Warfarin 443 (34.3%) 3,145 (33.2%) 1,721 (33.8%) 642 (31.8%) 47 (30.1%)
Age (years) 67.8 ± 10.7 70.1 ± 8.5 73.7 ± 8.0 74.7 ± 7.3 72.0 ± 8.3 <0.001
Weight (kg) 81.0 ± 23.5 83.2 ± 19.9 82.0 ± 18.5 82.6 ± 18.3 88.1 ± 19.5 <0.001
N (%) N (%) N (%) N (%) N (%)
Female 333 (25.8%) 3,136 (33.1%) 2,005 (39.4%) 1,011 (50.0%) 84 (53%) <0.001
Race White 756 (58.5%) 6,626 (69.8%) 3,684 (72.4%) 1,450 (71.7%) 108 (69.2%) <0.001
Black 21 (1.6%) 105 (1.1%) 31 (0.6%) 15 (0.7%) 3 (1.9%)
Asian 376 (29.1%) 1,658 (17.5%) 602 (11.8%) 216 (10.7%) 18 (11.5%)
Paroxysmal AF 426 (33.0%) 3,167 (33.4%) 1,630 (32%) 633 (31.3%) 58 (37.2%) 0.18
Permanent/Persistent AF 867 (67.0%) 6,316 (66.6%) 3,461 (68.0%) 1,388 (68.7%) 98 (62.8%)
CHADS2 Score
0-1 474 (36.7%) 3,523 (37.1%) 1,360 (26.7%) 383 (18.9%) 26 (16.7%) <0.001
2 472 (36.5%) 3,300 (34.8%) 1,896 (37.3%) 723 (35.8%) 46 (29.5%)
3 231 (17.9%) 1,732 (18.3%) 1,112 (21.8%) 508 (25.1%) 50 (32.1%)
4 88 (6.8%) 703 (7.4%) 524 (10.3%) 267 (13.2%) 26 (16.7%)
5 to 6 29 (2.2%) 229 (2.4%) 199 (3.9%) 141 (7.0%) 8 (5.1%)
Hypertension 912 (70.5%) 7,270 (76.6%) 4,151 (81.5%) 1,756 (86.8%) 139 (89.1%) <0.001
History of Stroke/ TIA 176 (13.6%) 1,191 (12.6%) 610 (12%) 273 (13.5%) 19 (12.2%) 0.31
Heart failure 416 (32.2%) 2,786 (29.4%) 1,683 (33.1%) 803 (39.7%) 85 (54.5%) <0.001
Diabetes Mellitus 297 (23%) 2,018 (21.3%) 1,190 (23.4%) 636 (31.5%) 64 (41%) <0.001
Antiplatelet 496 (38.4%) 3,741 (39.0%) 2,154 (42.3%) 926 (45.8%) 70 (44.9%) <0.001
ARISTOTLE (n=18,187) N=1,872 N=9,960 N=4,598 N=1,582 N=175
Apixaban 941 (51.3%) 4,975 (50.0%) 2,304 (50.1%) 809 (50.1%) 84 (48.0%)
Warfarin 931 (49.7%) 4,985 (50.0%) 2,294 (49.9%) 773 (48.9%) 91 (52.0%)
Age (years) 63.2 ± 10.9 68.0 ± 9.4 71.8 ± 8.8 74.5 ± 8.1 73.3 ± 8.0 <0.001
Weight (kg) 85.6 ± 23.8 84.6 ± 20.6 83.2 ± 20.0 81.4 ± 19.2 82.3 ± 17.2 <0.001
N (%) N (%) N (%) N (%) N (%)
Female 513 (27.4%) 3,137 (31.5%) 1,895 (41.2%) 779 (49.2%) 88 (50.3%) <0.001
Race White 1,403 (75%) 8,142 (81.8%) 3,946 (85.8%) 1,382 (87.4%) 154 (88%) <0.001
Black 47 (2.5%) 122 (1.22%) 42 (0.91%) 14 (0.88%) 2 (1.1%)
Asian 369 (19.7%) 1,515 (15.2%) 556 (12.1%) 172 (10.9%) 18 (10.3%)
Paroxysmal AF 282 (15.1%) 1,558 (15.6%) 689 (15%) 240 (15.2%) 22 (12.6%) 0.68
Permanent/Persistent AF 1,589 (84.9%) 8,401 (84.4%) 3,908 (85%) 1,342 (84.8%) 153 (87.4%)
CHADS2 Score <0.001
0-1 815 (43.5%) 3,796 (38.1%) 1,276 (27.8%) 267 (16.9%) 29 (16.6%)
2 662 (35.4%) 3,501 (35.2%) 1,686 (36.7%) 607 (38.4%) 50 (28.6%)
3 266 (14.2%) 1,624 (16.3%) 937 (20.4%) 387 (24.5%) 62 (35.4%)
4 103 (5.5%) 768 (7.7%) 486 (10.6%) 200 (12.6%) 24 (13.7%)
5 to 6 26 (1.4%) 271 (2.7%) 213 (4.6%) 121 (7.6%) 10 (5.7%)
Hypertension 1,568 (83.8%) 8,611 (86.5%) 4,107 (89.3%) 1,454 (91.9%) 166 (94.9%) <0.001
History of Stroke/ TIA 288 (15.4%) 1,784 (17.9%) 928 (20.2%) 345 (21.8%) 34 (19.4%) <0.001
Heart failure 624 (33.3%) 3,331 (33.4%) 1,720 (37.4%) 677 (42.8%) 90 (51.4%) <0.001
Diabetes Mellitus 523 (27.9%) 2,325 (23.3%) 1,138 (24.8%) 492 (31.1%) 63 (36%) <0.001
Antiplatelet 613 (32.8%) 3,117 (31.3%) 1,525 (33.2%) 571 (36.1%) 73 (41.7%)
ENGAGE (n=20,798) N=1,929 N=10,805 N=5,682 N=2,139 N=243
Edoxaban 30mg 649 (33.6%) 3,591 (33.2%) 1,888 (33.2%) 717 (33.5%) 81 (33.3%)
Edoxaban 60mg 663 (34.4%) 3,578 (33.1%) 1,895 (33.4%) 718 (33.6%) 78 (32.1%)
Warfarin 617 (32.0%) 3,636 (33.7%) 1,899 (33.4%) 704 (32.9%) 84 (34.6%)
Age (years) 65.1 ± 10.4 69.0 ± 9.3 73.0 ± 8.4 74.7 ± 7.9 73.3 ± 8.2 <0.001
Weight (kg) 85.8 ± 23.0 84.4 ± 21.0 82.8 ± 19.7 83.8 ± 19.4 89.3 ± 20.6 <0.001
N (%) N (%) N (%) N (%) N (%)
Female 493 (25.6%) 3,606 (33.4%) 2,589 (45.6%) 1,090 (51.0%) 134 (55.1%) <0.001
Race White 1,457 (75.5%) 8,634 (79.9%) 4,698 (82.7%) 1,810 (84.6%) 213 (87.7%) <0.001
Black 51 (2.6%) 143 (1.3%) 57 (1.0%) 19 (0.9%) 4 (1.7%)
Asian 345 (17.9%) 1,587 (14.7%) 700 (12.3%) 230 (10.8%) 14 (5.8%)
Paroxysmal AF 500 (25.9%) 2,708 (25.1%) 1,494 (26.3%) 523 (24.5%) 61 (25.1%) 0.33
Permanent/Persistent AF 1,429 (74.1%) 8,095 (74.9%) 4,188 (73.7%) 1,615 (75.5%) 182 (74.8%)
CHADS2 Score
0-1 excluded excluded excluded excluded excluded
2 1,084 (56.2%) 5,545 (51.3%) 2,537 (44.7%) 785 (32.10%) 78 (32.1%) <0.001
3 520 (27.0%) 3,141 (29.1%) 1778 (31.3%) 754 (35.3%) 97 (39.9%)
4 250(13.0%) 1,542 (14.3%) 894 (15.7%) 399 (18.7%) 44 (18.1%)
5 to 6 75 (3.9%) 577 (5.4%) 473 (8.3%) 201 (9.4%) 21 (9.9%)
Hypertension 1,756 (91.0%) 10,030 (92.8%) 5,393 (94.9%) 2,053 (96.0%) 233 (95.9%) <0.001
History of Stroke/ TIA 569 (29.5%) 3,351 (31.0%) 1,708 (30.0%) 395 (28.6%) 55 (22.6%) <0.001
Heart failure 1,127 (58.4%) 6,086 (56.3%) 3,261 (57.4%) 1,320 (61.7%) 168 (69.1%) <0.001
Diabetes Mellitus 789 (40.9%) 3,805 (35.2%) 1,976 (34.8%) 822 (38.4%) 129 (53.1%) <0.001
Antiplatelet 609 (31.6%) 3,337 (30.9%) 1,820 (32.0%) 720 (33.7%) 89 (36.6%) 0.04

Patients of other race are not included in this table (edoxaban n=835; apixaban 302)

CHADS2 denotes a cumulative score assigning one point each for congestive heart failure, hypertension, age >75, Diabetes and two points for a prior stroke/TIA

Missing data for Type of AF (RELY n=5; ARISTOTLE n=3; ENGAGE n=4), History of Stroke/ TIA (ENGAGE n=1)