Table 3.
Baseline characteristics for all intention-to-treat patients and for patients grouped by the absence or presence of significant valvular disease
| Variable | Overall trial population (N = 14 171) | SVD (N = 1992) | No SVD (N = 12 179) | P-value |
|---|---|---|---|---|
| Age, years | 73 (65, 78) | 75 (68, 79) | 72 (65, 78) | <0.0001 |
| Female | 5605 (39.6%) | 785 (39.4%) | 4820 (39.6%) | 0.89 |
| Race | ||||
| White | 11 786 (83.2%) | 1672 (83.9%) | 10 114 (83.0%) | <0.0001 |
| Black | 180 (1.3%) | 20 (1.0%) | 160 (1.3%) | |
| Asian | 1786 (12.6%) | 273 (13.7%) | 1513 (12.4%) | |
| Other | 419 (3.0%) | 27 (1.4%) | 392 (3.2%) | |
| Hispanic | 2331 (16.4%) | 156 (7.8%) | 2175 (17.9%) | <0.0001 |
| Region | ||||
| Asia/Pacific Islands | 2109 (14.9%) | 301 (15.1%) | 1808 (14.8%) | <0.0001 |
| Eastern Europe | 5407 (38.2%) | 582 (29.2%) | 4825 (39.6%) | |
| Latin America | 1878 (13.3%) | 76 (3.8%) | 1802 (14.8%) | |
| North America | 2681 (18.9%) | 653 (32.8%) | 2028 (16.7%) | |
| Western Europe | 2096 (14.8%) | 380 (19.1%) | 1716 (14.1%) | |
| Body mass index, kg/m2 | 28.2 (25.1, 32.0) | 27.7 (24.8, 31.2) | 28.3 (25.2, 32.1) | <0.0001 |
| Systolic blood pressure, mm Hg | 130 (120, 140) | 130 (120, 140) | 130 (120, 140) | |
| Diastolic blood pressure, mm Hg | 80 (70, 85) | 80 (70, 84) | 80 (70, 86) | |
| Type of atrial fibrillation | ||||
| Persistent | 11 485 (81.0%) | 1653 (83.0%) | 9832 (80.7%) | 0.049 |
| Paroxysmal | 2490 (17.6%) | 317 (15.9%) | 2173 (17.8%) | |
| Newly diagnosed or new onset | 196 (1.4%) | 22 (1.1%) | 174 (1.4%) | |
| Years since AF diagnosis | 3 (1, 7) | 4 (1, 8) | 3 (1, 7) | <0.0001 |
| Prior chronic aspirin use | 5184 (36.6%) | 690 (34.6%) | 4494 (36.9%) | 0.052 |
| Prior vitamin K antagonist use | 8853 (62.5%) | 1444 (72.5%) | 7409 (60.8%) | <0.0001 |
| CHADS2 score, mean (SD) | 3.5 (0.9) | 3.5 (1.0) | 3.5 (0.9) | 0.98 |
| HAS-BLED score, mean (SD) | 2.8 (0.9) | 2.8 (1.0) | 2.8 (0.9) | 0.18 |
| Previous stroke, embolism, or TIA | 7767 (54.8%) | 961 (48.2%) | 6806 (55.9%) | <0.0001 |
| Congestive heart failure | 8851 (62.5%) | 1402 (70.4%) | 7449 (61.2%) | <0.0001 |
| Hypertension | 12 824 (90.5%) | 1775 (89.1%) | 11 049 (90.7%) | 0.023 |
| Diabetes mellitus | 5647 (39.8%) | 798 (40.1%) | 4849 (39.8%) | 0.84 |
| Previous myocardial infarction | 2446 (17.3%) | 482 (24.2%) | 1964 (16.1%) | <0.0001 |
| Peripheral vascular disease | 832 (5.9%) | 160 (8.0%) | 672 (5.5%) | <0.0001 |
| COPD | 1481 (10.5%) | 287 (14.4%) | 1194 (9.8%) | <0.0001 |
| Previous CABG | 1029 (7.3%) | 238 (11.9%) | 791 (6.5%) | <0.0001 |
| Current smoker | 4760 (33.6%) | 768 (38.6%) | 3992 (32.8%) | <0.0001 |
| Creatinine clearance,a mL/min | 67 (52, 87) | 62 (49, 80) | 68 (53, 88) | <0.0001 |
Patients with significant vascular disease were from the intention-to-treat population that was used for analysis of efficacy outcomes. Continuous variables are shown as median (25th, 75th percentiles). Categorical variables are shown as n (%). P-values are from Wilcoxon rank sum tests for continuous variables and Pearson Chi-square tests for categorical variables.
CABG, indicates coronary artery bypass graft; COPD, chronic obstructive pulmonary disease; HAS-BLED, score for assessing bleeding risk (Hypertension; Abnormal renal/liver function; Stroke history; Bleeding predisposition; Labile international normalized ratio; Elderly, age ≥65; Drug/alcohol usage); TIA, transient ischaemic attack.
aCockcroft–Gault.