Table 1.
Baseline patient characteristics
| Characteristics | Additional educational program (Na = 579) | Primary SOC (Na = 583) |
|---|---|---|
| Age (years) | 73.1 ± 9.1 | 72.6 ± 8.9 |
| Age ≥ 75 years | 282 (48.7) | 276 (47.3) |
| Female | 234 (40.4) | 232 (39.8) |
| Weight (kg) | 81.7 ± 16.7 | 82.8 ± 17.7 |
| Heart rate (bpm) | 74.9 ± 16.7 | 74.3 ± 15.9 |
| SBP (mmHg) | 132.7 ± 16.4 | 135.0 ± 17.1 |
| DBP (mmHg) | 78.0 ± 10.7 | 79.5 ± 10.8 |
| MMSE | 28.2 ± 1.7 | 28.3 ± 1.6 |
| Type of diagnosis | ||
| AF | 557 (96.4) | 562 (96.4) |
| Atrial flutter | 19 (3.3) | 18 (3.1) |
| AF + atrial flutter | 2 (0.3) | 3 (0.5) |
| Type of NVAF | ||
| Paroxysmal | 301 (52.4) | 280 (48.4) |
| Persistent | 137 (23.9) | 148 (25.6) |
| Permanent | 136 (23.7) | 150 (26.0) |
| Stroke and bleeding risk factors | ||
| Congestive heart failure | 93 (16.1) | 83 (14.2) |
| Hypertension | 497 (85.8) | 516 (88.5) |
| Diabetes mellitus | 151 (26.1) | 154 (26.4) |
| History of stroke or TIA | 107 (18.5) | 94 (16.1) |
| History of coronary heart disease/stent or PVD | 142 (24.5) | 138 (23.7) |
| Renal failureb | 11 (1.9) | 7 (1.2) |
| CHADS2 | 2.1 ± 1.0 | 2.1 ± 1.1 |
| CHA2DS2-VASc | 3.6 ± 1.3 | 3.6 ± 1.4 |
| HAS-BLED | 1.7 ± 0.8 | 1.7 ± 0.8 |
| High risk of bleeding (HAS-BLED ≥ 3) | 87 (15.2) | 87 (15.1) |
| Baseline VKA status | ||
| VKA naïvec | 370 (63.9) | 371 (63.6) |
| VKA treatedd | 207 (35.8) | 210 (36.0) |
| Concomitant medications at baseline | 5.1 ± 2.9 | 5.0 ± 2.7 |
| Previous treatment with ASA | 114 (19.7) | 116 (19.9) |
| Concomitant treatment with ASA | 100 (17.9) | 89 (14.8) |
| Dose of study drug assigned at baseline (mg) | ||
| 5 | 499 (86.2) | 512 (88.1) |
| 2.5 | 80 (13.8) | 69 (11.9) |
ASA acetylsalicylic acid, AF atrial fibrillation, DBP diastolic blood pressure, MMSE Mini Mental State Examination, NVAF non-valvular atrial fibrillation, PVD peripheral vascular disease, SBP systolic blood pressure, SOC standard of care, TIA transient ischemic attack, VKA vitamin K antagonist
Values are mean ± standard deviation or n (%)
aN represents the number of patients contributing to summary statistics. All percentages are based on the number of patients with available data for each characteristic
bCreatinine clearance < 30 ml/min
cVKA-naïve patients must not have received VKA treatment for > 30 days within the last 12 months
dVKA-treated patients must have received the VKA treatment for > 3 months