Table 1.
No ventricular arrhythmia | Ventricular arrhythmia a | p‐value b | Ventricular arrhythmia/ICD shock/resuscitated cardiac arrest c | p‐value b | |
---|---|---|---|---|---|
n (%) | 8066 (96.0) | 333 (4.0) | 372 (4.4) | ||
Age (years) | 64 ± 11 | 64 ± 11 | 0.450 | 64 ± 11 | 0.570 |
Race, n (%) | <0.001 | <0.001 | |||
White | 5291 (65.6) | 253 (76.0) | 277 (74.5) | ||
Black | 406 (5.0) | 22 (6.6) | 27 (7.3) | ||
Asian | 1477 (18.3) | 32 (9.6) | 37 (9.9) | ||
Other | 892 (11.1) | 26 (7.8) | 31 (8.3) | ||
Region, n (%) | <0.001 | <0.001 | |||
North America | 538 (6.7) | 64 (19.2) | 73 (19.6) | ||
Latin America | 1388 (17.2) | 45 (13.5) | 52 (14.0) | ||
Western Europe | 1920 (23.8) | 131 (39.3) | 143 (38.4) | ||
Central Europe | 2764 (34.3) | 62 (18.6) | 68 (18.3) | ||
Asia‐Pacific and other | 1456 (18.1) | 31 (9.3) | 36 (9.7) | ||
Male sex, n (%) | 6282 (77.9) | 285 (85.6) | <0.001 | 320 (86.0) | <0.001 |
SBP (mmHg) | 122 ± 15 | 118 ± 15 | <0.001 | 117 ± 15 | <0.001 |
Heart rate (bpm) | |||||
Sinus rhythm | 72 ± 11 | 69 ± 11 | 0.002 | 69 ± 11 | <0.001 |
AF/flutter d | 74 ± 13 | 69 ± 12 | <0.001 | 70 ± 12 | 0.002 |
BMI (kg/m2) | 28 ± 6 | 29 ± 6 | 0.003 | 29 ± 6 | 0.003 |
eGFR (ml/min/1.73 m2) | 68 ± 20 | 64 ± 22 | <0.001 | 64 ± 21 | <0.001 |
eGFR <60 ml/min/1.73 m2, n (%) | 2908 (36.1) | 153 (45.9) | <0.001 | 173 (46.5) | <0.001 |
LVEF (%) | 30 [25–34] | 30 [25–33] | <0.001 | 30 [25–32] | <0.001 |
LVEF, n (%) | 0.002 | <0.001 | |||
< median | 3218 (39.9) | 161 (48.3) | 184 (49.5) | ||
≥ median | 4847 (60.1) | 172 (51.7) | 188 (50.5) | ||
NT‐proBNP (pg/ml) ‐ no AF/flutter d | 1447 [814–2955] | 1377 [768–3111] | 0.880 | 1477 [775–3140] | 0.920 |
NT‐proBNP (pg/ml) ‐ AF/flutter d | 1885 [1095–3646] | 1981 [1053–3954] | 0.850 | 2009 [1138–3976] | 0.590 |
Troponin (µg/L) e | 0.015 [0.010–0.023] | 0.018 [0.012–0.026] | 0.013 | 0.017 [0.011–0.025] | 0.055 |
Plasma aldosterone (pmol/L) e | 243 [152–386] | 258 [159–372] | 0.420 | 268 [160–386] | 0.230 |
Galectin (ng/ml) e | 18.7 ± 6.9 | 18.6 ± 6.7 | 0.800 | 18.8 ± 6.8 | 0.940 |
Cystatin C (mg/L) e | 1.2 ± 0.4 | 1.2 ± 0.4 | 0.400 | 1.2 ± 0.4 | 0.270 |
Urinary cyclic‐GMP (nmol/L) e | 1109 [683–1813] | 1417 [827–1956] | 0.015 | 1397 [827–1920] | 0.021 |
Potassium (mmol/L) | 4.5 ± 0.5 | 4.5 ± 0.5 | 0.680 | 4.5 ± 0.5 | 0.760 |
Sodium (mmol/L) | 141 ± 3 | 141 ± 3 | 0.300 | 141 ± 3 | 0.097 |
RBBB, n (%) | 604 (7.5) | 23 (6.9) | 0.690 | 24 (6.5) | 0.450 |
LBBB, n (%) | 1583 (19.6) | 70 (21.0) | 0.530 | 79 (21.2) | 0.440 |
QRS duration (ms) | 117 ± 36 | 134 ± 35 | <0.001 | 134 ± 35 | <0.001 |
NYHA class, n (%) | 0.120 | 0.200 | |||
I | 379 (4.7) | 10 (3.0) | 12 (3.2) | ||
II | 5666 (70.4) | 253 (76.0) | 280 (75.3) | ||
III | 1949 (24.2) | 69 (20.7) | 78 (21.0) | ||
IV | 59 (0.7) | 1 (0.3) | 2 (0.5) | ||
KCCQ‐CSS | 80 [63–92] | 80 [67–91] | 0.840 | 80 [67–91] | 0.800 |
Medical history, n (%) | |||||
Duration of heart failure | <0.001 | <0.001 | |||
<1 year | 2455 (30.7) | 45 (13.5) | 52 (14.0) | ||
1–5 years | 3085 (38.6) | 118 (35.4) | 131 (35.2) | ||
>5 years | 2445 (30.6) | 170 (51.1) | 189 (50.8) | ||
Ischaemic aetiology | 4820 (59.8) | 216 (64.9) | 0.062 | 239 (64.2) | 0.084 |
Previous ventricular arrhythmia | 185 (2.3) | 47 (14.1) | <0.001 | 50 (13.4) | <0.001 |
Hypertension | 5716 (70.9) | 224 (67.3) | 0.160 | 256 (68.8) | 0.410 |
Diabetes | 2768 (34.3) | 128 (38.4) | 0.120 | 139 (37.4) | 0.230 |
AF history | 2951 (36.6) | 107 (32.1) | 0.098 | 127 (34.1) | 0.350 |
AF/flutter on baseline ECG | 2036 (25.2) | 54 (16.2) | <0.001 | 64 (17.2) | <0.001 |
Prior HF hospitalization | 5069 (62.8) | 205 (61.6) | 0.640 | 232 (62.4) | 0.860 |
MI | 3460 (42.9) | 174 (52.3) | <0.001 | 196 (52.7) | <0.001 |
PCI | 1702 (21.1) | 99 (29.7) | <0.001 | 112 (30.1) | <0.001 |
CABG | 1215 (15.1) | 88 (26.4) | <0.001 | 97 (26.1) | <0.001 |
Stroke | 693 (8.6) | 32 (9.6) | 0.520 | 35 (9.4) | 0.590 |
COPD | 1035 (12.8) | 45 (13.5) | 0.720 | 52 (14.0) | 0.510 |
Anaemia f | 1626 (20.2) | 66 (19.8) | 0.880 | 76 (20.4) | 0.890 |
Medical therapy, n (%) | |||||
Loop diuretic | 6053 (75.0) | 264 (79.3) | 0.079 | 294 (79.0) | 0.081 |
Thiazide/thiazide‐related diuretic | 1133 (14.0) | 52 (15.6) | 0.420 | 57 (15.3) | 0.490 |
Prior ACE inhibitor | 6275 (77.8) | 257 (77.2) | 0.790 | 287 (77.2) | 0.770 |
Prior ARB | 1814 (22.5) | 78 (23.4) | 0.690 | 89 (23.9) | 0.510 |
Beta‐blocker | 7500 (93.0) | 311 (93.4) | 0.770 | 350 (94.1) | 0.400 |
MRA | 4847 (60.1) | 184 (54.8) | 0.078 | 208 (55.9) | 0.110 |
Digoxin | 2449 (30.4) | 90 (27.0) | 0.190 | 107 (28.8) | 0.530 |
Amiodarone | 728 (9.0) | 55 (16.5) | <0.001 | 62 (16.7) | <0.001 |
Sotalol | 37 (0.5) | 4 (1.2) | 0.057 | 4 (1.1) | 0.097 |
ICD or CRT‐D | 1078 (13.4) | 165 (49.5) | <0.001 | 182 (48.9) | <0.001 |
CRT‐D | 371 (4.6) | 53 (15.9) | <0.001 | 59 (15.9) | <0.001 |
CRT‐P | 145 (1.8) | 5 (1.5) | 0.690 | 6 (1.6) | 0.800 |
Values are mean ± standard deviation, or median [interquartile range], unless otherwise indicated.
ACE, angiotensin‐converting enzyme; AF, atrial fibrillation; ARB, angiotensin receptor blocker; BMI, body mass index; CABG, coronary artery bypass graft; COPD, chronic obstructive pulmonary disease; CRT‐D, cardiac resynchronization therapy‐defibrillator; CRT‐P, cardiac resynchronization therapy‐pacemaker; ECG, electrocardiogram; eGFR, estimated glomerular filtration rate; HF, heart failure; ICD, implantable cardioverter defibrillator; KCCQ‐CSS, Kansas City Cardiomyopathy Questionnaire clinical summary score; LBBB, left bundle branch block; LVEF, left ventricular ejection fraction; MI, myocardial infarction; MRA, mineralocorticoid receptor antagonist; NT‐proBNP, N‐terminal pro B‐type natriuretic peptide; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; RBBB, right bundle branch block; SBP, systolic blood pressure.
Ventricular arrhythmia was defined as any adverse event report using the MedDRA preferred terms ‘ventricular tachycardia’ (VT), ‘ventricular fibrillation’, ‘ventricular flutter’, ‘torsades de pointes’, ‘ventricular tachyarrhythmia’ and ‘ventricular arrhythmia’. Premature ventricular ectopics were excluded.
p‐value compared to no ventricular arrhythmia.
372 patients with a ventricular arrhythmia/ICD shock/resuscitated cardiac arrest compared to 8027 patients with no ventricular arrhythmia.
Based on a history of AF or baseline ECG documenting AF or atrial flutter.
Biomarkers measured in subsets of patients: plasma troponin n = 1947; plasma aldosterone n = 1976; galectin‐3 n = 2043; cystatin C n = 2056; urinary cyclic‐GMP n = 2033.
Anaemia was defined as haemoglobin <130 g/L in males and <120 g/L in females.