Overall (n=14 068) | Rivaroxaban 2.5 mg two times per day plus aspirin 100 mg od (n=7027) | Aspirin 100 mg od (n=7041) | P value | |
Age, years | 67.9 (7.9) | 67.8 (7.9) | 67.9 (7.9) | 0.47 |
Women, n (%) | 3123 (22.2) | 1597 (22.7) | 1526 (21.7) | 0.13 |
Blood pressure, mm Hg | ||||
Systolic | 135.3 (17.3) | 135.2 (17.3) | 135.3 (17.3) | 0.73 |
Diastolic | 77.7 (9.9) | 77.6 (9.8) | 77.7 (9.9) | 0.45 |
Cholesterol, mmol/L (IQR) | 4.03 (3.48–4.76) | 4.03 (3.48–4.76) | 4.03 (3.48–4.73) | 0.89 |
Tobacco use, n (%) | 3067 (21.8) | 1551 (22.1) | 1516 (21.5) | 0.44 |
Hypertension, n (%) | 10 578 (75.2) | 5303 (75.5) | 5275 (74.9) | 0.45 |
Diabetes, n (%) | 5199 (37.0) | 2587 (36.8) | 2612 (37.1) | 0.73 |
Prior stroke, n (%) | 502 (3.6) | 261 (3.7) | 241 (3.4) | 0.35 |
Prior MI, n (%) | 8859 (63.0) | 4384 (62.4) | 4475 (63.6) | 0.15 |
Heart failure, n (%) | 3103 (22.1) | 1569 (22.3) | 1534 (21.8) | 0.44 |
Coronary artery disease, n (%) | 12 837 (91.3) | 6428 (91.5) | 6409 (91.0) | 0.34 |
Peripheral artery disease, n (%) | 3646 (25.9) | 1807 (25.7) | 1839 (26.1) | 0.59 |
Estimated GFR, n (%) | ||||
15–29 mL/min per 1.73 m2 | 106 (0.8) | 50 (0.7) | 56 (0.8) | 0.57 |
30–59 mL/min per 1.73 m2 | 2898 (20.6) | 1433 (20.4) | 1465 (20.8) | 0.55 |
≥60 mL/min per 1.73 m2 | 11 062 (78.6) | 5542 (78.9) | 5520 (78.4) | 0.48 |
Race, n (%) | ||||
White | 8701 (61.9) | 4349 (61.9) | 4352 (61.8) | 0.92 |
Black | 133 (1.0) | 62 (0.9) | 71 (1.0) | 0.44 |
Asian | 2163 (15.4) | 1089 (15.5) | 1074 (15.3) | 0.69 |
Other | 3071 (21.8) | 1527 (21.7) | 1544 (21.9) | 0.78 |
Geographic regions, n (%) | ||||
North America | 1860 (13.2) | 933 (13.3) | 927 (13.2) | 0.85 |
South America | 3263 (23.2) | 1627 (23.2) | 1636 (23.2) | 0.91 |
Western Europe | 4321 (30.7) | 2139 (30.4) | 2182 (31.0) | 0.48 |
Eastern Europe | 2609 (18.6) | 1321 (18.8) | 1288 (18.3) | 0.44 |
Asia Pacific and other | 2015 (14.3) | 1007 (14.3) | 1008 (14.3) | 0.98 |
Medications, n (%) | ||||
ACE inhibitor or ARB | 10 022 (71.2) | 4998 (71.1) | 5024 (71.4) | 0.77 |
Calcium-channel blocker | 3673 (26.1) | 1801 (25.6) | 1872 (26.6) | 0.20 |
Diuretic | 4081 (29.0) | 2051 (29.2) | 2030 (28.8) | 0.64 |
Beta-blocker | 9904 (70.4) | 4934 (70.2) | 4970 (70.6) | 0.63 |
Lipid-lowering agent | 12 728 (90.5) | 6385 (90.9) | 6343 (90.1) | 0.12 |
NSAID | 745 (5.3) | 399 (5.7) | 346 (4.9) | 0.04 |
Non-trial PPI | 4947 (35.2) | 2445 (34.8) | 2502 (35.5) | 0.36 |
Randomised to PPI | 4545 (32.3) | 2285 (32.5) | 2260 (32.1) | 0.92 |
Randomised to PPI placebo | 4573 (32.5) | 2294 (32.7) | 2279 (32.4) | 0.92 |
Data are mean±SD, medians with IQR or proportion percentage (%).
ACE, angiotensin converting enzyme; ARB, angiotensin receptor blocker; GFR, glomerular filtration rate; MI, myocardial infarction; NSAID, non-steroidal anti-inflammatory drugs; od, once a day; PPI, proton pump inhibitor.