Table 2: Comparison of Different Populations Enrolled and of Different Outcomes in Major RCTs in Chronic HFREF.
| PARADIGM-HF[37] | DAPA-HF[38] | EMPERORReduced[41] | GALACTIC-HF[76] | VICTORIA[70] | |
|---|---|---|---|---|---|
| Main Baseline Characteristics of Different Populations Enrolled | |||||
| Total population enrolled | 8,442 | 4,744 | 3,730 | 8,256 | 5,050 |
| Mean age, years | 63.8 | 66.4 | 66.9 | 64.5 | 67.3 |
| Women | 22% | 23% | 24% | 21.3% | 23.9% |
| NYHA classification | |||||
| Class II Class III Class IV |
70.9% 24.1% 0.7% |
67.5% 31.6% 0.9% |
75.1% 24.4% 0.5% |
53.2% 43.8% 3.0% |
59.0% 39.7% 1.3% |
| LVEF (%; mean) | 29.5 | 31.1 | 27.5 | 26.6 | 28.9 |
| NT-pro-BNP, median, pg/ml | 1,608 | 1,437 | 1,906 | 1,971 | 2,816 |
| Previous HF hospitalisations | |||||
| Any time ≤12 months randomisation ≤6 months randomisation ≤3 months randomisation |
63% N/A 31.1% 19.1% |
47.4% 27% 16.4% 7.8% |
30.8% 30.8% N/A N/A |
74.4% 74.4% 54.6% 36.2% |
83.9% 83.9% 83.9% 66.7% |
| Currently hospitalised for AHF (worsening) | N/A | N/A | N/A | 25.2% | N/A |
| Ischaemic aetiology | 59.7% | 56.4% | 51.7% | 54.0% | 58.3% |
| Stroke | 8.7% | 9.9% | 11.3% | 9.1% | 11.5 % |
| Hypertension | 71.2% | 74% | 72.3% | 70.3% | 79.1% |
| Anaemia | 20.3% | 27.6% | N/A | N/A | 20.9% |
| COPD | 12.9% | 12.3% | 11.9% | 16.3% | 17.2% |
| AF/flutter | 37% | 38.3% | 36.7% | 42.1% | 44.9% |
| Systolic blood pressure (mmHg mean) | 121 | 122 | 122 | 117 | 121 |
| Heart rate (beats/min mean) | 72 | 71 | 71 | 72 | 73 |
| eGFR (ml/min/1.73 m2) Mean | 70 | 65.8 | 62 | 60.3 | 61.5 |
| <60 ml/min/1.73 m2 | 33% | 40.2% | 48.3% | 52.5% | 52% |
| T2D | 34.9% | 41.8% | 49.8% | 40.1% | 46.9% |
| Comparison of HFREF GDMT | |||||
| ACE-I/ARB | 100% | 83.7% | 69.7% | 67.4% | 73.5% |
| ARNI | N/A | 10.7% | 19.5% | 19.3% | 14.5% |
| β-blocker | 93.6% | 96.1% | 94.7% | 94.0% | 93.1% |
| MRA | 55.3% | 71% | 71.3% | 77.0% | 70.3% |
| Ivabradine | 2% | 5% | N/A | 6.5% | N/A |
| SGLT2i | N/A | N/A | N/A | 2.7% | N/A |
| ICD | 14.9% | 26.2% | 31.4% | 31.7% | 27.8% |
| CRT | 6.8% | 7.5% | 11.8% | 14.0% | 14.7% |
| Annualised Event Rate in the Comparator Group | |||||
| CV death | 7.5% | 7.9% | 8.1% | 10.8% | 13.9% |
| First HF hospitalisation | 8.5% | 9.8% | 15.5% | 15.2% | 29.1% |
| All-Cause Death Observed in the Total Follow-up in the Comparator Group | |||||
| Mean follow-up (months) | 27 | 18.2 | 16.0 | 21.8 | 10.8 |
| All-cause death | 19.8% | 13.9% | 14.2% | 25.9% | 21.2% |
AHF = acute heart failure; CV = cardiovascular; COPD = chronic obstructive pulmonary disease; CRT = cardiac resynchronisation therapy; eGFR = estimated glomerular filtration rate; HF = heart failure; LVEF = left ventricular ejection fraction; NT-pro-BNP = N-terminal pro-B type natriuretic peptide; NYHA = New York Heart Association; SGLT2i = sodium-glucose cotransporter type 2 inhibitors; T2D = type 2 diabetes.