Introduction
Methods
Study design and participants
Randomisation and masking
Procedures
Outcome measures
Protocol amendment
Statistical analysis
Results
Baseline characteristics
NICC | SoC | |
---|---|---|
Primary diagnosis, prior to randomisation | ||
Atrial fibrillation | 132 (27.7) | 133 (27.7) |
Heart failure | 202 (42.4) | 204 (42.5) |
Treatment-resistant hypertension | 143 (30.0) | 143 (29.8) |
Inpatient | 16 (3.4) | 16 (3.3) |
Male sex | 281 (58.9) | 304 (63.3) |
Age | 71.3 (± 10.4) | 71.1 (± 10.8) |
Smoking | ||
Current | 45 (9.4) | 51 (10.6) |
Former | 207 (43.4) | 232 (48.4) |
Never | 225 (47.2) | 196 (40.9) |
Diabetes mellitus | 148 (31.0) | 158 (33.0) |
Physical examination | ||
Body mass index (kg/m2) | 29.7 (5.3) | 29.9 (5.9) |
Systolic blood pressure | 137.3 (19.9) | 136.8 (20.4) |
Diastolic blood pressure | 80.0 (10.0) | 78.9 (10.8) |
Electrocardiogram (ECG) | ||
Heart rhythm | ||
Sinus rhythm | 347 (72.7) | 343 (71.6) |
Atrial fibrillation | 94 (19.7) | 88 (18.4) |
Pacemaker ECG | 34 (7.1) | 43 (9.0) |
Other | 2 (0.4) | 5 (1.0) |
Atrioventricular block | 65 (13.6) | 69 (14.4) |
Left thigh block | 36 (7.6) | 44 (9.2) |
Right thigh block | 52 (10.9) | 47 (9.8) |
ECG 2D | ||
Left ventricular end diastolic pressure (mm) | 50.1 (8.3) | 49.9 (9.7) |
Left ventricular ejection fraction (%) | 56.2 (10.9) | 55.9 (10.6) |
Diastolic dysfunction grade 0 (normal) | 145 (37.9) | 136 (35.9) |
I (impaired relaxation) | 172 (44.9) | 175 (46.2) |
II (pseudo-normal) | 42 (11.0) | 40 (10.6) |
III (restrictive) | 4 (1.1) | 5 (1.4) |
Unknown | 20 (5.2) | 23 (6.1) |
NICC | SoC | |
---|---|---|
Cardiovascular diseases | ||
Atrial fibrillation | 210 (44.0) | 230 (47.9) |
EHRA Stadium I | 12 (5.7) | 11 (4.8) |
II | 169 (79.6) | 192 (83.5) |
III | 24 (11.4) | 21 (9.1) |
IV | 0 (0.0) | 2 (0.9) |
ESC class paroxysmal atrial fibrillation | 103 (49.0) | 125 (54.3) |
ESC class persistent atrial fibrillation | 46 (21.9) | 55 (23.9) |
ESC class long-lasting persistent atrial fibrillation | 5 (2.4) | 2 (0.9) |
Previous hospitalisation due to atrial fibrillation | 119 (56.7) | 127 (55.2) |
Angina pectoris | 34 (7.1) | 31 (6.5) |
CCS Grade I | 7 (20.6) | 3 (9.7) |
II | 16 (47.1) | 23 (74.2) |
III | 7 (20.6) | 2 (6.5) |
Unknown | 4 (11.8) | 3 (9.7) |
Hypertension | 341 (71.5) | 342 (71.2) |
Previous hospitalisation due to hypertension | 56 (16.5) | 68 (19.9) |
Heart failure | 213 (44.7) | 210 (43.8) |
NYHA stadium I | 8 (3.8) | 5 (2.4) |
II | 145 (68.1) | 137 (65.2) |
III | 56 (26.3) | 67 (31.9) |
IV | 3 (1.4) | 1 (0.5) |
Unknown | 1 (0.5) | 0 (0.0) |
AHA stadium A | 3 (1.4) | 3 (1.4) |
B | 126 (59.2) | 113 (53.8) |
C | 72 (33.8) | 78 (37.1) |
D | 3 (1.4) | 1 (0.5) |
Unknown | 9 (4.2) | 15 (7.1) |
Previous hospitalisation due to heart failure | 111 (52.4) | 116 (55.2) |
Medical history | ||
Coronary artery disease | 239 (50.1) | 244 (50.8) |
Previous myocardial infarction | 103 (21.6) | 118 (24.6) |
Modified CHA2DS2-VASc score | 3.8 (1.7) | 3.7 (1.6) |
Primary heart valve disease | 54 (11.3) | 61 (12.7) |
Cardiomyopathy | 25 (5.2) | 34 (7.1) |
Cardiac decompensation | 42 (8.8) | 59 (12.3) |
Coronary revascularization | 164 (34.6) | 162 (33.8) |
Bypass surgery | 60 (12.6) | 71 (14.8) |
Heart valve surgery | 48 (10.1) | 43 (9.0) |
Catheter ablation | 42 (8.8) | 48 (10.0) |
Pacemaker | 50 (10.5) | 50 (10.4) |
Defibrillator | 27 (5.7) | 35 (7.3) |
Peripheral artery disease | 35 (7.3) | 47 (9.8) |
Cardiovascular risk factors | ||
1st degree relative with myocardial infarction < 50 years | 57 (11.9) | 49 (10.2) |
Primary outcomes
NICC | SoC | RR/OR | p-value | |||
---|---|---|---|---|---|---|
Events | Mean/percentage (95% CI) | Events | Mean/percentage (95% CI) | |||
Primary endpoints | ||||||
Death, stroke, or myocardial infarction | 6 | 1.5 (0.6–3.3) | 23 | 5.2 (3.3–7.7) | 3.35 (1.36–8.26) | 0.009 |
Number of inpatient treatment days | 5.04 (3.95–6.12) | 6.51 (4.94–8.09) | 1.30 (0.93–1.81) | 0.122 | ||
Death, stroke, myocardial infarction, or cardiac decompensation | 14 | 3.6 (2.0–5.9) | 35 | 8.1 (5.7–11.1) | 2.22 (1.17–4.24) | 0.016 |
Secondary endpoints | ||||||
All-cause mortality | 4 | 1.0 (0.3–2.6) | 23 | 5.3 (3.4–7.8) | 4.43 (1.55–12.62) | 0.006 |
Time-to-event analysis | 5.15 (1.78–14.89) | 0.002 | ||||
Atrial fibrillation | 0 | 0.0 (0.0–3.2) | 8 | 6.7 (2.9–12.7) | ||
Heart failure | 4 | 2.5 (0.7–6.4) | 13 | 7.2 (3.9–12.0) | ||
Treatment-resistant hypertension | 0 | 0.0 (0.0–3.0) | 2 | 1.5 (0.2–5.2) | ||
Cardiovascular death | 3 | 0.8 (0.2–2.2) | 15 | 3.4 (1.9–5.6) | 3.85 (1.16––12.81) | 0.029 |
Atrial fibrillation | 0 | 0.0 (0.0–3.2) | 5 | 4.2 (1.4–9.5) | ||
Heart failure | 3 | 1.9 (0.4–5.5) | 9 | 5.0 (2.3–9.3) | ||
Treatment-resistant hypertension | 0 | 0.0 (0.0–3.0) | 1 | 0.7 (0.0–4.1) | ||
Cardiac decompensation | 8 | 2.0 (0.9–4.0) | 13 | 3.0 (1.6–5.1) | 1.41 (0.58–3.46) | 0.450 |
Major adverse cardiovascular event (MACE) | 5 | 1.3 (0.4–3.0) | 15 | 3.5 (2.0–5.7) | 2.50 (0.89–7.02) | 0.083 |
Time-to-event analysis | 3.41 (1.39–8.37) | 0.008 | ||||
Number of hospitalisations | 0.71 (0.60–0.83) | 0.75 (0.63–0.87) | 1.06 (0.85–1.33) | 0.603 | ||
After adjusting for number of hospitalizations over the 1 year preceding randomisation | 1.01 (0.81–1.26) | 0.908 |