Table 1.
Baseline patient characteristics
| Ferric carboxymaltose (n = 558) | Placebo (n = 550) | |
|---|---|---|
| Age, years | 71.20 (10.80) | 70.89 (11.14) |
| Sex | ||
| Female | 244 (43.7) | 250 (45.5) |
| Male | 314 (56.3) | 300 (54.5) |
| Race | ||
| American Indian or Alaska Native | 1 (0.2) | 0 |
| Asian | 26 (4.7) | 22 (4.0) |
| Black or African American | 3 (0.5) | 4 (0.7) |
| Other | 0 | 1 (0.2) |
| White | 528 (94.6) | 523 (95.1) |
| Hypertension | 468 (83.9) | 471 (85.6) |
| Dyslipidaemia | 300 (53.8) | 292 (53.1) |
| Atrial fibrillation | 314 (56.3) | 305 (55.5) |
| Smoking | 217 (38.9) | 202 (36.7) |
| Myocardial infarction | 229 (41.0) | 213 (38.7) |
| Diabetes mellitus | 227 (40.7) | 243 (44.2) |
| Coronary revascularization | 195 (34.9) | 206 (37.5) |
| Angina pectoris | 91 (16.3) | 78 (14.2) |
| Stroke | 53 (9.5) | 66 (12.0) |
| Baseline diastolic blood pressure, mmHg | 72.59 (10.31) | 71.87 (9.91) |
| Baseline systolic blood pressure, mmHg | 119.76 (15.24) | 119.69 (15.64) |
| Baseline heart rate, bpm | 74.49 (13.18) | 74.23 (12.76) |
| Baseline BMI, kg/m2 | 28.13 (5.64) | 28.03 (5.71) |
| Baseline eGFR (CKD‐EPI), mL/min/1.73 m2 | 55.38 (21.36) | 55.75 (23.07) |
| Baseline NYHA class | 1 (0.2) | 3 (0.5) |
| I | 14 (2.5) | 8 (1.5) |
| II | 255 (45.7) | 240 (43.6) |
| III | 272 (48.7) | 277 (50.4) |
| IV | 16 (2.9) | 22 (4.0) |
| Baseline LVEF, % | 32.64 (9.59) | 32.74 (9.94) |
| <25% | 104 (18.6) | 122 (22.2) |
| ≥25% and <40% | 288 (51.6) | 243 (44.2) |
| ≥40% and <50% | 166 (29.7) | 184 (33.5) |
| Heart failure aetiology | ||
| Ischaemic | 265 (47.5) | 257 (46.7) |
| Non‐ischaemic | 282 (50.5) | 275 (50.0) |
| Unknown | 11 (2.0) | 18 (3.3) |
| Baseline haemoglobin category | ||
| Anaemic a | 292 (52.3) | 312 (56.7) |
| Non‐anaemic | 265 (47.5) | 238 (43.3) |
| Newly diagnosed heart failure | 153 (27.4) | 165 (30.0) |
| Patients with ARNI, yes/no | 35 (6.3) | 36 (6.5) |
| Patients with ACEi or ARB or ARNI, yes/no | 420 (75.3) | 414 (75.3) |
| Patients with beta‐blockers | 453 (81.2) | 461 (83.8) |
| Patients with aldosterone antagonists | 376 (67.4) | 352 (64.0) |
| Patients with triple therapy | 247 (44.3) | 238 (43.3) |
| Baseline haemoglobin, g/dL | 12.26 (1.62) | 12.14 (1.60) |
| Baseline serum phosphorus, mg/dL | 4.28 (12.58) | 3.83 (0.98) |
| Baseline serum ferritin, ng/mL | 83.85 (62.15) | 88.47 (68.64) |
| Baseline TSAT, % | 15.15 (8.31) | 14.23 (7.47) |
| NT‐proBNP pg/mL | 4743 (2781–8128) | 4684 (2785–8695) |
For continuous variables, numbers represent mean (standard deviation); for categorical variables, numbers represent n (%).
ACEi, angiotensin‐converting enzyme inhibitor; ARB, angiotensin receptor blocker; ARNI, angiotensin receptor–neprilysin inhibitor; BMI, body mass index; CKD‐EPI, Chronic Kidney Disease Epidemiology Collaboration; eGFR, estimated glomerular filtration rate; LVEF, left ventricular ejection fraction; NT‐proBNP, N‐terminal pro B‐type natriuretic peptide; NYHA, New York Heart Association; TSAT, transferrin saturation.
a
Defined as <12 g/dL in non‐pregnant females and <13 g/dL in males.