Table 1.
Patients characteristics who were initiated on Sac/Val in comparison to the patients enrolled in the PARADIGM-HF trial.
| Variable | Real-World N = 400 | PARADIGM-HF N = 4187 | P value |
|---|---|---|---|
| Age – yr (mean ± SD) | 58.6 ± 13.8 | 63.8 ± 11.5 | <.0001 |
| Female sex – no. (%) | 123 (30.8) | 879 (21.0) | <.0001 |
| Body-mass index (mean ± SD) | 29.5 ± 6.8 | 28.1 ± 5.5 | <.0001 |
| NYHA functional classification – no. (%) | |||
| Class I | 82 (20.50) | 180 (4.3) | <.0001 |
| Class II | 195 (48.75) | 2998 (71.6) | <.0001 |
| Class III | 89 (22.25) | 969 (23.1) | .6867 |
| Class IV | 34 (8.50) | 33 (0.8) | <.0001 |
| Median B-type natriuretic peptide, median (IQR) – pg/mL | 459 (139–600) | 255 (155–474) | <.0001 |
| Left ventricular ejection fraction – % (mean ± SD) | 26.5 ± 8.4 | 29.6 ± 6.1 | <.0001 |
| Systolic blood pressure – mm Hg (mean ± SD) | 121 ± 17 | 122 ± 15 | .2525 |
| Heart rate – beats/min (mean ± SD) | 73 ± 10 | 72 ± 12 | .3452 |
| Medical history – no. (%) | |||
| Hypertension | 270 (67.5) | 2969 (70.9) | .1344 |
| Myocardial infarction | 193 (48.3) | 1818 (43.4) | .0503 |
| Stroke | 46 (11.5) | 355 (8.5) | .0314 |
| Hospitalization for heart failure | NA | 2607 (62.3) | NA |
| Atrial fibrillation | 83 (20.8) | 1517 (36.2) | <.0001 |
| Diabetes mellitus | 255 (63.75) | 1451 (34.7) | <.0001 |
| Previous use of ACEi | 138 (34.50) | 3266 (78.0) | <.0001 |
| Previous use of ARB | 127 (31.8) | 929 (22.2) | <.0001 |
| Serum creatinine – mg/dL (mean ± SD) | 1.07 ± 0.31 | 1.13 ± 0.3 | .0001 |
| Device therapy – no. (%) | |||
| Implantable cardioverter–defibrillator | 56 (14) | 623 (14.9) | .6132 |
| Cardiac resynchronization therapy | 45 (11.3) | 292 (7.0) | .0009 |
| Heart failure medication – no. (%) | |||
| Diuretic | 328 (82) | 3363 (80.3) | .3926 |
| Beta-blocker | 364 (91) | 3899 (93.1) | .1169 |
| Mineralocorticoid receptor antagonist | 252 (63) | 2271 (54.2) | .0004 |
| Sodium-glucose Cotransporter-2 inhibitors | 177 (44.3) | NA | NA |
| Digoxin | 40 (10) | 1223 (29.2) | <.0001 |
ACE = angiotensin-converting-enzyme, ARB = angiotensin receptor blocker, IQR = interquartile range, NYHA = New York Heart Association, Sac/val = sacubitril/valsartan, SD = standard deviation.