Table 2.
Incidence rate and univariate analysis by Cox proportional hazards analysis of stroke/systemic embolism
| No. of events (%/year) | HR | 95% CI | p value | |
|---|---|---|---|---|
| Overall | 176 (1.0) | |||
| Sex | ||||
| Male | 115 (1.0) | Reference | 0.5283 | |
| Female | 61 (1.1) | 1.1 | 0.8, 1.5 | |
| Age class 1 (years-old) | ||||
| < 65 | 23 (0.7) | Reference | 0.0176 | |
| ≥ 65 | 153 (1.1) | 1.7 | 1.1, 2.6 | |
| Age class 2 (years-old) | ||||
| < 65 | 23 (0.7) | Reference | 0.0022 | |
| 65–74 | 60 (0.9) | 1.3 | 0.8, 2.2 | |
| ≥ 75 | 93 (1.3) | 2.0 | 1.3, 3.2 | |
| Body weight (kg) | ||||
| ≥ 60 | 84 (0.8) | Reference | 0.0250 | |
| 50–59 | 50 (1.1) | 1.3 | 0.9, 1.9 | |
| < 50 | 33 (1.4) | 1.7 | 1.1, 2.6 | |
| Systolic blood pressure (mmHg) | ||||
| < 160 | 156 (1.0) | Reference | 0.0928 | |
| ≥ 160 | 12 (1.6) | 1.6 | 0.9, 3.0 | |
| CrCl (mL/min) | ||||
| ≥ 50 | 112 (0.9) | Reference | 0.0026 | |
| 30–49 | 49 (1.5) | 1.8 | 1.3, 2.5 | |
| < 30 | 3 (1.0) | 1.2 | 0.4, 3.7 | |
| Comorbiditya | ||||
| Congestive heart failure | ||||
| – | 129 (1.0) | 1.0 | 0.7, 1.4 | 0.8550 |
| + | 47 (1.0) | |||
| Hypertension | ||||
| – | 44 (0.9) | 1.2 | 0.9, 1.7 | 0.2768 |
| + | 132 (1.1) | |||
| Angina pectoris | ||||
| – | 157 (1.0) | 0.9 | 0.6, 1.5 | 0.7193 |
| + | 19 (0.9) | |||
| Diabetes mellitus | ||||
| – | 121 (0.9) | 1.4 | 1.1, 2.0 | 0.0227 |
| + | 55 (1.3) | |||
| Aortic aneurysm | ||||
| – | 174 (1.0) | 0.8 | 0.2, 3.3 | 0.7916 |
| + | 2 (0.8) | |||
| Deep vein thrombosis | ||||
| – | 175 (1.0) | 1.0 | 0.2, 7.4 | 0.9718 |
| + | 1 (1.0) | |||
| Pulmonary embolism | ||||
| – | 175 (1.0) | 2.3 | 0.3, 16.2 | 0.4012 |
| + | 1 (2.2) | |||
| Dyslipidemia | ||||
| – | 105 (1.0) | 0.9 | 0.7, 1.3 | 0.6278 |
| + | 71 (1.0) | |||
| Liver dysfunction | ||||
| – | 167 (1.0) | 0.9 | 0.5, 1.7 | 0.6999 |
| + | 9 (0.9) | |||
| Renal dysfunction | ||||
| – | 176 (1.0) | < 0.001 | < 0.001 | 0.6995 |
| + | 0 (0.0) | |||
| Medical historya | ||||
| Stroke (ischemic/hemorrhagic) | ||||
| – | 91 (0.7) | Reference | < 0.0001 | |
| + | 85 (2.3) | 3.6 | 2.7, 4.8 | |
| Transient ischemic attack | ||||
| – | 169 (0.9) | Reference | 0.4721 | |
| + | 7 (1.3) | 1.3 | 0.6, 2.8 | |
| Systemic embolism | ||||
| – | 174 (1.0) | Reference | 0.6643 | |
| + | 2 (1.4) | 1.4 | 0.3, 5.5 | |
| Vascular disease (MI/PAD) | ||||
| – | 158 (1.0) | Reference | 0.0352 | |
| + | 18 (1.6) | 1.7 | 1.0, 2.7 | |
| Malignant tumor | ||||
| – | 159 (1.0) | Reference | 0.7657 | |
| + | 17 (1.1) | 1.1 | 0.7, 1.8 | |
| Bleeding/disposition of bleeding | ||||
| – | 169 (1.0) | Reference | 0.9900 | |
| + | 7 (1.0) | 1.0 | 0.5, 2.1 | |
| Rivaroxaban dosage | ||||
| 15 mg/day | 87 (0.9) | Reference | 0.0658 | |
| 10 mg/day | 89 (1.2) | 1.3 | 1.0, 1.8 | |
| Amount of drinking (unit/week) | ||||
| No | 105 (1.1) | Reference | 0.1202 | |
| < 8 | 47 (0.8) | 0.7 | 0.5, 1.0 | |
| ≥8 | 24 (1.0) | 0.9 | 0.6, 1.4 | |
| History of smoking | ||||
| No | 99 (0.9) | Reference | 0.2940 | |
| In the past | 54 (1.1) | 1.1 | 0.8, 1.6 | |
| Current | 23 (1.3) | 1.4 | 0.9, 2.2 | |
| Type of AF | ||||
| PAF | 67 (0.9) | Reference | 0.0799 | |
| Non-PAFb | 109 (1.1) | 1.3 | 1.0, 1.8 | |
| Using concomitant anti-plateletsa | ||||
| – | 138 (0.9) | Reference | 0.0046 | |
| + | 38 (1.5) | 1.7 | 1.2, 2.4 | |
| Using concomitant NSAIDsa | ||||
| – | 172 (1.0) | Reference | 0.9525 | |
| + | 4 (1.0) | 1.0 | 0.4, 2.8 | |
| CHADS2 score | ||||
| < 3 | 76 (0.7) | Reference | < 0.0001 | |
| ≥ 3 | 100 (1.7) | 2.7 | 2.0, 3.6 | |
| CHA2DS2-VASc score | ||||
| < 4 | 58 (0.6) | Reference | < 0.0001 | |
| ≥ 4 | 118 (1.5) | 2.5 | 1.9, 3.5 | |
| HAS-BLED score | ||||
| < 2 | 60 (0.6) | Reference | < 0.0001 | |
| ≥ 2 | 106 (1.7) | 2.8 | 2.0, 3.8 | < 0.0001 |
HR hazard ratio, CI confidence interval, CrCl creatinine clearance, MI myocardial infarction, PAD peripheral arterial disease, AF atrial fibrillation, PAF paroxysmal atrial fibrillation, NSAIDs non-steroidal anti-inflammatory drugs
P values were determined by log-rank test
aReference; without factor
bPersistent and permanent atrial fibrillation