Introduction
Methods
Study population and follow-up
Study outcomes
Statistical considerations
Results
Baseline characteristics
Age (years), mean ± SD | 69.2 ± 8.9 | |
---|---|---|
≥75, n (%) | 254 (28.3%) | |
Gender (male), n (%) | 583 (64.8%) | |
Weight (kg), mean ± SD | 85.8 ± 17.1 | |
Creatinine clearance (ml/min), n (%) | ||
15–29 | 5 (0.6%) | |
30–49 | 48 (5.3%) | |
≥50 | 527 (58.6%) | |
Missing | 319 (35.5%) | |
Atrial fibrillation type, n (%) | ||
First diagnosed | 170 (18.9%) | |
Paroxysmal | 473 (52.6%) | |
Persistent | 98 (10.9%) | |
Permanent | 158 (17.6%) | |
CHADS2 score, median (IQR) | 1 (1–2) | |
<2 | 556 (61.8%) | |
≥2 | 343 (38.2%) | |
CHA2DS2-VASc score, median (IQR) | 2 (2–4) | |
HAS-BLED score, median (IQR) | 2 (1–2) | |
≥3 | 161 (17.9%) | |
Prior stroke/TIA/non-CNS SE, n (%) | 107 (11.9%) | |
Congestive heart failure, n (%) | 58 (6.5%) | |
Hypertension, n (%) | 550 (61.2%) | |
Coronary artery disease, n (%) | 93 (10.3%) | |
Peripheral artery disease, n (%) | 47 (5.2%) | |
Diabetes mellitus, n (%) | 143 (15.9%) | |
Prior use of antithrombotic therapy, n (%) | 779 (86.7%) | |
VKA | 559 (62.2%) | |
Direct thrombin inhibitor | 14 (1.6%) | |
ASA | 120 (13.3%) |
Study outcomes
Incidence proportion,
n (%) | Incidence rate, events per 100 patient-years (95% CI) | ||
---|---|---|---|
Primary outcomes
| Major bleeding | 19 (2.1%) | 2.4 (1.4–3.7) |
All-cause mortality | 8 (0.9%) | 1.0 (0.4–2.0) | |
Secondary outcomes
| Thromboembolic event | 13 (1.4%) | 1.6 (0.9–2.8) |
Non-major bleeding | 142 (15.8%) | 19.6 (16.5–23.1) |
Number of patients (%) | ||
---|---|---|
Major bleeding
| 19 (2.1%) | |
Gastrointestinal | 7 (0.8%) | |
Intracranial | 4 (0.4%) | |
Genitourinary | 2 (0.2%) | |
Conjunctival | 1 (0.1%) | |
Intraocular | 1 (0.1%) | |
Musculoskeletal | 1 (0.1%) | |
Skin | 1 (0.1%) | |
Surgery site | 1 (0.1%) | |
Not reported | 1 (0.1%) | |
Non-major bleeding
| 142 (15.8%) | |
Nasal | 56 (6.2%) | |
Genitourinary | 27 (3.0%) | |
Skin | 26 (2.9%) | |
Gastrointestinal | 21 (2.3%) | |
Other | 12 (1.3%) |