Introduction
Methods
Patients
Design
Echocardiographic procedures
Definition of high-risk echocardiographic features
Randomisation
Follow-up
Quality of life questionnaires
Data collection
Endpoints
Statistical analysis
Results
Baseline characteristics
Randomised patients | Non-randomised patients (observational group) |
p-value | |
---|---|---|---|
n = 241 |
n = 69 | ||
Clinical characteristics | |||
Age (years) | 65 ± 11 | 69 ± 9 | 0.004 |
Male,% | 66 | 61 | 0.479 |
Hypertension,% | 90 | 86 | 0.388 |
Coronary artery disease,% | 9 | 20 | 0.018 |
Diabetes,% | 10 | 19 | 0.057 |
Transient ischaemic attack,% | 1.7 | 7.2 | 0.029 |
CHADS2 score | 1.2 ± 0.6 | 1.6 ± 1.0 | <0.001 |
- Score 0,% | 2.1 | 4.3 | |
- Score 1,% | 76.3 | 53.6 | |
- Score ≥2,% | 21.6 | 42.1 | |
Time since 1st diagnosis AF (years) | 4.9 ± 9.0 | 4.6 ± 6.1 | 0.754 |
Type of AF | 0.320 | ||
- Paroxysmal,% | 85 | 78 | |
- Permanent,% | 15 | 22 | |
Body mass index (g/m2) | 28 ± 5 | 28 ± 5 | 0.458 |
Systolic blood pressure (mmHg) | 136 ± 18 | 137 ± 18 | 0.615 |
Diastolic blood pressure (mmHg) | 80 ± 9 | 82 ± 10 | 0.288 |
Antithrombotic drug at baseline,% | 99 | 99 | 0.637 |
- VKA at baseline,% | 69 | 82 | 0.032 |
- Aspirin at baseline,% | 32 | 18 | 0.023 |
Echocardiography | |||
AF during TEE,% | 25 | 54 | <0.001 |
Left atrial diameter (mm) | 41 ± 11 | 42 ± 12 | 0.389 |
Left ventricular ejection fraction (%) | 59 ± 8 | 56 ± 8 | 0.016 |
Left ventricular mass (g/m2) | 124 ± 83 | 130 ± 102 | 0.571 |
End-diastolic septum width (mm) | 9.6 ± 2.6 | 10.1 ± 3.2 | 0.204 |
End-diastolic posterior wall width (mm) | 9.1 ± 2.4 | 9.5 ± 2.6 | 0.211 |
Mitral incompetence,% | 55 | 70 | 0.038 |
Feasibility of TEE-guided stroke risk assessment
n = 69 | |
---|---|
Technical reasons/patient refusal | 1 |
At least one TEE risk factor not clearly visible | 5 |
At least one TEE risk factor present | 63 |
- 1 TEE abnormality | 49 |
- 2 TEE abnormalities | 13 |
- 3 TEE abnormalities | 0 |
- 4 TEE abnormalities | 1 |