Table 1. Baseline Characteristics in the ARISTOTLE Cohort by Aspirin Status on Day 1 (Day of Randomization) and in the RE-LY Cohort by Aspirin Status During Follow-up, Anytime During the Study, Including Biomarkers Used in the ABC-Bleeding Score.
| Variable | Patients, No. (%) | |||
|---|---|---|---|---|
| ARISTOTLE | RE-LY | |||
| No aspirin (n = 10 342) | Aspirin (n = 4638) | No aspirin (n = 5956) | Aspirin (n = 3413) | |
| Randomized treatment: warfarin | 5193 (50.2) | 2289 (49.4) | 1985 (33.3) | 1144 (33.5) |
| Received dabigatran | ||||
| 110 mg | NA | NA | 1972 (33.1) | 1137 (33.3) |
| 150 mg | NA | NA | 1999 (33.6) | 1132 (33.2) |
| Age, y, median (IQR) | 70.0 (62.0-76.0) | 70.0 (63.0-76.0) | 72.0 (67.0-77.0) | 72.0 (67.0-78.0) |
| Female | 3769 (36.4) | 1562 (33.7) | 2275 (38.2) | 1133 (33.2) |
| Body mass index, median (IQR)a | 28.5 (25.3-32.5) | 28.6 (25.3-32.8) | 28.0 (25.1-31.6) | 27.9 (25.1-31.2) |
| Missing values, No. | 49 | 22 | 3 | 4 |
| Systolic blood pressure, mm Hg, median (IQR) | 130.0 (120.0-140.0) | 130.0 (120.0-140.0) | 130.0 (120.0-142.0) | 130.0 (120.0-140.0) |
| Missing values, No. | 25 | 8 | 8 | 5 |
| Diabetes | 2454 (23.7) | 1243 (26.8) | 1196 (20.1) | 883 (25.9) |
| Hypertension | 8961 (86.6) | 4153 (89.5) | 4660 (78.2) | 2731 (80.0) |
| Current smoker | 870 (8.4) | 349 (7.5) | 467 (7.8) | 254 (7.4) |
| Missing values, No. | 12 | 2 | ||
| Alcohol | 264 (2.6) | 114 (2.5) | 866 (14.5) | 456 (13.4) |
| Permanent or persistent atrial fibrillation | 8865 (85.7) | 3846 (82.9) | 4255 (71.5) | 2078 (60.9) |
| Missing values, No. | 3 | 0 | 2 | 2 |
| Prior stroke or transient ischemic attack | 1948 (18.8) | 861 (18.6) | 1159 (19.5) | 664 (19.5) |
| Prior bleeding | 1701 (16.4) | 736 (15.9) | 678 (11.4) | 505 (14.8) |
| Anemia | 665 (6.4) | 342 (7.4) | 678 (11.4) | 505 (14.8) |
| Missing values, No. | 6 | 5 | 0 | 0 |
| Heart failure | 3115 (30.1) | 1536 (33.1) | 1685 (28.3) | 1026 (30.1) |
| Missing values, No. | 0 | 0 | 1 | 0 |
| Prior myocardial infarction | 1008 (9.7) | 918 (19.8) | 747 (12.5) | 842 (24.7) |
| Missing values, No. | 1 | 0 | 0 | 0 |
| Prior peripheral arterial disease | 456 (4.4) | 274 (5.9) | 186 (3.1) | 159 (4.7) |
| Missing values, No. | 1 | 0 | 1 | 0 |
| Prior vascular disease | 2028 (19.6) | 1695 (36.5) | 882 (14.8) | 937 (27.5) |
| Warfarin within 7 d of randomization | 6455 (62.5) | 1582 (34.2) | 4397 (73.8) | 1609 (47.1) |
| Missing values, No. | 18 | 11 | 0 | 0 |
| Estimated glomerular filtration rate, mL/min, median (IQR) | 74.5 (57.0-96.0) | 73.1 (56.1-93.8) | 65.5 (54.5-77.4) | 63.7 (52.7-76.4) |
| Missing values, No. | 37 | 15 | 68 | 23 |
| Growth differentiation factor 15, ng/L, median (IQR) | 1348.0 (965.0-1992.0) | 1464.0 (1005.0-2216.0) | 1476.0 (1092.0-2124.0) | 1592.0 (1142.2-2338.0) |
| Missing values, No. | 117 | 65 | 467 | 251 |
| High-sensitive cardiac troponin T, ng/L, median (IQR) | 10.7 (7.4-16.3) | 11.6 (7.8-17.6) | 11.7 (7.5-18.8) | 13.1 (8.2-20.6) |
| Missing values, No. | 49 | 34 | 417 | 233 |
| Hemoglobin, g/dL, median (IQR) | 14.3 (13.2-15.3) | 14.2 (13.1-15.3) | 14.3 (13.3-15.3) | 14.2 (13.1-15.3) |
| Missing values, No. | 53 | 17 | 100 | 59 |
Abbreviations: ABC, age, biomarkers, and clinical history; ARISTOTLE, Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation; IQR, interquartile range; NA, not applicable; RE-LY, Randomized Evaluation of Long-term Anticoagulation Therapy.
SI conversion factor: To convert hemoglobin to grams per liter, multiply by 10.0.
a
Body mass index is calculated as weight in kilograms divided by height in meters squared.