Table 1. Baseline characteristics of included patients.
| Variable | Overall ( N = 57,813) | Major bleeding ( N = 1,948) |
No major bleeding ( N = 55,865) |
Major GI bleeding ( N = 717) |
Intracranial bleeding ( N = 274) |
|---|---|---|---|---|---|
| Randomized treatment arm | |||||
| Aspirin | 15,475 (26.8) | 222 (11.4) | 15,248 (27.3) | 77 (10.7) | 46 (16.8) |
| Warfarin | 5,879 (10.2) | 404 (20.7) | 5,472 (9.8) | 108 (15.1) | 78 (28.5) |
| DOAC, therapeutic dose | 18,216 (31.5) | 793 (40.7) | 17,409 (31.2) | 313 (43.7) | 82 (29.9) |
| Rivaroxaban alone | 9,108 (15.8) | 246 (12.6) | 8,862 (15.9) | 88 (12.3) | 39 (14.2) |
| Rivaroxaban + Aspirin | 9,135 (15.8) | 283 (14.5) | 8,851 (15.9) | 131 (18.3) | 29 (10.6) |
| Age (years) | 70.0 (65.0, 75.0) | 74.0 (69.0, 79.0) | 69.0 (65.0, 75.0) | 75.0 (69.0, 79.0) | 74.0 (68.0, 79.0) |
| Sex: Female | 17,518 (30.3) | 582 (29.9) | 16,936 (30.3) | 209 (29.1) | 79 (28.8) |
| Race | |||||
| Asian | 9,550 (16.5) | 300 (15.4) | 9,250 (16.6) | 116 (16.2) | 77 (28.1) |
| Black/African American | 579 (1.0) | 26 (1.3) | 553 (1.0) | 11 (1.5) | 4 (1.5) |
| White/Caucasian | 37,796 (65.4) | 1,361 (69.9) | 36,435 (65.2) | 477 (66.5) | 161 (58.8) |
| Other | 9,886 (17.1) | 261 (13.4) | 9,625 (17.2) | 113 (15.8) | 32 (11.7) |
| Weight (kg) | 79.3 (69.0, 90.7) | 80.0 (68.2, 91.6) | 79.2 (69.0, 90.7) | 79.2 (69.0, 90.7) | 75.0 (66.0, 85.0) |
| Height (cm) | 169.0 (162.0, 175.3) |
170.0 (162.0, 176.0) |
169.0 (162.0, 175.3) |
169.0 (162.0, 175.3) |
169.4 (162.0, 176.0) |
| BMI | 27.7 (24.8, 31.1) | 27.8 (24.6, 31.1) | 27.7 (24.8, 31.1) | 27.7 (24.8, 31.1) | 26.1 (23.6, 29.7) |
| Hip circumference a (cm) | 104.0 (97.0, 111.0) |
104.1 (98.0, 112.0) |
104.0 (97.0, 111.0) |
104.0 (98.0, 111.8) |
102.0 (96.0, 109.0) |
| Waist circumference a (cm) | 100.0 (91.4, 109.0) |
101.0 (91.4, 110.0) |
100.0 (91.4, 109.0) |
100.0 (91.0, 110.0) |
98.5 (90.0, 106.7) |
| Waist-to-hip ratio a | 1.0 (0.9, 1.0) | 1.0 (0.9, 1.0) | 1.0 (0.9, 1.0) | 1.0 (0.9, 1.0) | 1.0 (0.9, 1.0) |
| Baseline diastolic blood pressure | 79.0 (70.0, 84.0) | 75.0 (68.5, 82.0) | 79.0 (70.0, 84.5) | 72.5 (67.3, 80.0) | 78.0 (70.0, 84.0) |
| Baseline systolic blood pressure | 132.0 (121.0, 144.0) | 131.0 (120.0, 144.0) | 132.0 (121.0, 144.0) | 130.8 (120.0, 144.0) | 134.0 (120.0, 145.5) |
| Pulse pressure | 55.0 (46.0, 64.5) | 56.0 (47.0, 67.0) | 55.0 (46.0, 64.0) | 57.0 (48.0, 69.0) | 55.0 (46.0, 64.0) |
| Heart rate | 70.0 (62.0, 78.0) | 70.0 (62.0, 80.0) | 70.0 (61.0, 78.0) | 70.0 (61.5, 78.0) | 70.0 (63.0, 78.0) |
| Creatinine (µmol/L) | 88.0 (74.0, 104.0) |
96.0 (80.0, 115.0) |
88.0 (73.0, 103.0) |
97.0 (80.0, 115.0) |
88.4 (79.0, 106.1) |
| GFR (mL/min per 1.73m 2 ) | 73.1 (58.4, 88.6) | 64.0 (50.0, 81.3) | 73.5 (59.0, 88.7) | 62.9 (48.2, 78.5) | 65.0 (51.6, 79.0) |
| PAD | 8,387 (14.5) | 272 (14.0) | 8,115 (14.5) | 105 (14.6) | 24 (8.8) |
| Stroke | 4,708 (8.1) | 202 (10.4) | 4,506 (8.1) | 62 (8.6) | 52 (19.0) |
| TIA | 2,949 (5.1) | 145 (7.4) | 2,804 (5.0) | 53 (7.4) | 18 (6.6) |
| Hypertension | 44,950 (77.8) | 1,576 (80.9) | 43,374 (77.6) | 582 (81.2) | 221 (80.7) |
| MI a | 20,242 (35.0) | 673 (34.5) | 19,569 (35.0) | 272 (37.9) | 84 (30.7) |
| Heart failure | 13,937 (24.1) | 522 (26.8) | 13,415 (24.0) | 213 (29.7) | 61 (22.3) |
| Atrial fibrillation b | 23,253 (40.2) | 1,176 (60.4) | 22,077 (39.5) | 414 (57.7) | 150 (54.7) |
| Coronary artery disease a | 30,194 (52.2) | 1,054 (54.1) | 29,140 (52.2) | 413 (57.6) | 127 (46.4) |
| Cancer | 4,568 (7.9) | 249 (12.8) | 4,319 (7.7) | 82 (11.4) | 31 (11.3) |
| Diabetes | 17,315 (30.0) | 610 (31.3) | 16,705 (29.9) | 226 (31.5) | 74 (27.0) |
| Prerandomization medication use | |||||
| ACE or ARB | 37,945 (65.6) | 1,327 (68.1) | 36,618 (65.5) | 499 (69.6) | 171 (62.4) |
| Calcium channel blocker | 16,113 (27.9) | 624 (32.0) | 15,489 (27.7) | 225 (31.4) | 82 (29.9) |
| Beta blocker | 34,505 (59.7) | 1,206 (61.9) | 33,299 (59.6) | 442 (61.6) | 154 (56.2) |
| Diuretic | 21,017 (36.4) | 927 (47.6) | 20,090 (36.0) | 362 (50.5) | 92 (33.6) |
| Statin | 38,739 (67.0) | 1,220 (62.6) | 37,519 (67.2) | 466 (65.0) | 155 (56.6) |
| Antiplatelet b | 44,077 (76.2) | 1,350 (69.3) | 42,727 (76.5) | 503 (70.2) | 197 (71.9) |
| Anticoagulant b | 8,488 (14.7) | 460 (23.6) | 8,028 (14.4) | 162 (22.6) | 62 (22.6) |
| PPI b | 14,083 (24.4) | 507 (26.0) | 13,576 (24.3) | 194 (27.1) | 70 (25.5) |
| NSAID | 3,060 (5.3) | 146 (7.5) | 2,914 (5.2) | 60 (8.4) | 20 (7.3) |
| >12 years education a | 17,759 (30.7) | 369 (18.9) | 17,390 (31.1) | 132 (18.4) | 66 (24.1) |
| Smoking | |||||
| Never | 24,307 (42.0) | 719 (36.9) | 23,588 (42.2) | 251 (35.0) | 111 (40.5) |
| Former | 24,459 (42.3) | 1,003 (51.5) | 23,456 (42.0) | 381 (53.1) | 129 (47.1) |
| Current | 9,041 (15.6) | 226 (11.6) | 8,815 (15.8) | 85 (11.9) | 34 (12.4) |
| > 5 drinks of alcohol/wk a | 16,975 (29.4) | 635 (32.6) | 16,340 (29.2) | 221 (30.8) | 83 (30.3) |
Abreviations: ACE, angiotensin-converting enzyme; ARB, angiotensin II receptor blockers; BMI, body mass index; DOAC, direct oral anticoagulant; GFR, glomerular filtration rate; MI, myocardial infarction;NSAID, nonsteroidal anti-inflammatory drugs; PAD, peripheral artery disease; PPI, proton-pump inhibitors; TIA, transient ischemic attack;
Note: Patients categorized according to first major bleeding event. Continuous variables are summarized as median (quartile 1, quartile 3). Categorical variables are summarized as frequency (percent).
a
Excluded from model building as variable not collected in all trials.
b
Excluded from model building because variable represents prerandomization use of a medication which was randomized in a trial, or an inclusion/exclusion criterion of a trial.