Table 1.
Baseline characteristics of patients according to the number of hospitalizations for worsening heart failure during the trial
| Number of hospitalizations for worsening HF during trial |
P-valuea | ||||
|---|---|---|---|---|---|
| None (n = 5319) | One (n = 714) | Two (n = 254) | Three or more (n = 218) | ||
| Demographic characteristics | |||||
| Age (years) | 60.0 ± 11.3 | 62.3 ± 11.1 | 61.8 ± 12.5 | 62.4 ± 11.7 | <0.0001 |
| Male | 4069 (77%) | 529 (74%) | 195 (77%) | 177 (81%) | 0.18 |
| Current smoker | 927 (17%) | 116 (16%) | 43 (17%) | 32 (15%) | 0.17 |
| BMI (kg/m²) | 28.0 ± 5.0 | 27.8 ± 5.4 | 27.9 ± 5.1 | 27.8 ± 5.3 | 0.29 |
| Cardiac parameters | |||||
| Heart rate (b.p.m.) | 79.3 ± 9.2 | 82.2 ± 11.3 | 83.4 ± 11.7 | 82.2 ± 10.1 | <0.0001 |
| SBP (mmHg) | 122.3 ± 15.7 | 119.8 ± 16.4 | 118.1 ± 16.9 | 117.6 ± 17.4 | <0.0001 |
| DBP (mmHg) | 76.0 ± 9.4 | 75.0 ± 10.0 | 73.4 ± 9.7 | 73.3 ± 9.4 | <0.0001 |
| LVEF (%) | 29.3 ± 5.0 | 27.6 ± 5.3 | 27.8 ± 5.3 | 27.1 ± 5.9 | <0.0001 |
| NYHA class II | 2724 (51%) | 274 (38%) | 96 (38%) | 75 (34%) | <0.0001 |
| NYHA class III | 2516 (47%) | 422 (59%) | 150 (59%) | 135 (62%) | |
| NYHA class IV | 77 (2%) | 18 (3%) | 8 (3%) | 8 (4%) | |
| eGFR (mL/min/1.73 m²) | 75.8 ± 22.7 | 70.4 ± 22.5 | 69.4 ± 22.7 | 68.0 ± 27.8 | <0.0001 |
| Medical history | |||||
| Duration of HF (years) | 3.3 ± 4.1 | 4.2 ± 4.5 | 4.3 ± 4.7 | 4.6 ± 4.7 | <0.0001 |
| Ischaemic cause of HF | 3605 (68%) | 503 (70%) | 171 (67%) | 139 (64%) | 0.27 |
| Myocardial infarction | 2986 (56%) | 423 (59%) | 142 (56%) | 115 (53%) | 0.30 |
| Hypertension | 3545 (67%) | 478 (67%) | 158 (62%) | 133 (61%) | 0.17 |
| Diabetes | 1552 (29%) | 251 (35%) | 88 (35%) | 88 (40%) | <0.0001 |
| Stroke | 398 (7%) | 66 (9%) | 30 (12%) | 29 (13%) | 0.0008 |
| History of atrial fibrillation and/or flutter | 389 (7%) | 83 (12%) | 24 (9%) | 26 (12%) | <0.0001 |
| CAD | 3863 (73%) | 536 (75%) | 182 (72%) | 151 (69%) | 0.33 |
| Treatment at randomization | |||||
| β-Blockers | 4797 (90%) | 633 (89%) | 203 (80%) | 187 (86%) | <0.0001 |
| ACE-inhibitor | 4216 (79%) | 535 (75%) | 193 (76%) | 172 (79%) | 0.043 |
| ARB | 741 (14%) | 111 (16%) | 41 (16%) | 34 (16%) | 0.48 |
| ACE-inhibitor and/or ARB | 4858 (91%) | 635 (89%) | 228 (90%) | 202 (93%) | 0.13 |
| Mineralocorticoid receptor antagonists | 3098 (58%) | 494 (69%) | 170 (67%) | 160 (73%) | <0.0001 |
| Diuretics | 4335 (82%) | 643 (90%) | 229 (90%) | 207 (95%) | <0.0001 |
| Digitalis | 1039 (20%) | 215 (30%) | 85 (33%) | 77 (35%) | <0.0001 |
Values are n (%) or means ± SD. ACE, angiotensin-converting enzyme; ARB, angiotensin receptor blocker; eGFR, estimated glomerular filtration rate (Modification in Diet in Renal Disease Formula); NYHA, New York Heart Association.
aThe Kruskal–Wallis test for continuous variables or the χ2 test for categorical variables.