Table 1.
Patients with baseline NT‐proBNP in Q1–Q3 | Patients with baseline NT‐proBNP in Q4 | |||||
---|---|---|---|---|---|---|
Characteristics | Vericiguat n = 1798 | Placebo n = 1806 | Total n = 3604 | Vericiguat n = 616 | Placebo n = 585 | Total n = 1201 |
Age (years), mean (SD) | 66.7 (12.2) | 66.6 (12.1) | 66.6 (12.1) | 69.4 (12.0) | 69.0 (11.9) | 69.2 (12.0) |
Male, n (%) | 1380 (76.8) | 1380 (76.4) | 2760 (76.6) | 458 (74.4) | 428 (73.2) | 886 (73.8) |
BMI (kg/m2), mean (SD) | 28.2 (6.0) | 28.3 (6.2) | 28.2 (6.1) | 26.2 (5.0) | 26.3 (5.5) | 26.3 (5.3) |
Race, n (%) | ||||||
White | 1319 (63.3) | 1135 (62.8) | 2274 (63.1) | 390 (63.3) | 368 (62.9) | 758 (63.1) |
Black | 83 (4.6) | 89 (4.9) | 172 (4.8) | 31 (5.0) | 29 (5.0) | 60 (5.0) |
Asian | 433 (24.1) | 418 (23.1) | 851 (23.6) | 132 (21.4) | 135 (23.1) | 267 (22.2) |
Other | 143 (8.0) | 164 (9.1) | 307 (8.5) | 63 (10.2) | 53 (9.1) | 116 (9.7) |
Geographic region, n (%) | ||||||
Eastern Europe | 588 (32.7) | 604 (33.4) | 1192 (33.1) | 217 (35.2) | 193 (33.0) | 410 (34.1) |
Western Europe | 296 (16.5) | 285 (15.8) | 581 (16.1) | 116 (18.8) | 111 (19.0) | 227 (18.9) |
Asia Pacific | 447 (24.9) | 437 (24.2) | 884 (24.5) | 135 (21.9) | 142 (24.3) | 277 (23.1) |
Latin America | 252 (14.0) | 273 (15.1) | 525 (14.6) | 101 (16.4) | 81 (13.8) | 182 (15.2) |
North America | 215 (12.0) | 207 (11.5) | 422 (11.7) | 47 (7.6) | 58 (9.9) | 105 (8.7) |
Randomized while hospitalized, n (%) | 189 (10.5) | 166 (9.2) | 355 (9.9) | 91 (14.8) | 87 (14.9) | 178 (14.8) |
Index event, n (%) | ||||||
HF hospitalization within 3 months | 1148 (63.8) | 1183 (65.5) | 2331 (64.7) | 450 (73.1) | 434 (74.2) | 884 (73.6) |
HF hospitalization within 3–6 months | 332 (18.5) | 305 (16.9) | 637 (17.7) | 99 (16.1) | 85 (14.5) | 184 (15.3) |
IV diuretic for HF (without hospitalization) within 3 months | 318 (17.7) | 318 (17.6) | 636 (17.6) | 67 (10.9) | 66 (11.3) | 133 (11.1) |
Medical history | ||||||
Ejection fraction, n | 1794 | 1803 | 3,597 | 612 | 585 | 1197 |
Mean (SD) % | 29.7 (8.2) | 29.4 (8.3) | 29.5 (8.2) | 27.2 (8.3) | 27.2 (8.4) | 27.2 (8.3) |
Ejection fraction ≤40%, n (%) | 1654 (92.2) | 1656 (91.8) | 3310 (92.0) | 582 (95.1) | 548 (93.7) | 1130 (94.4) |
NYHA class at baseline, n (%) | ||||||
Class I | 0 (0.0) | 1 (0.1) | 1 (0.0) | 0 (0.0) | 1 (0.2) | 1 (0.1) |
Class II | 1139 (63.3) | 1146 (63.5) | 2285 (63.4) | 275 (44.6) | 274 (46.8) | 549 (45.7) |
Class III | 641 (35.7) | 642 (35.5) | 1283 (35.6) | 325 (52.8) | 297 (50.8) | 622 (51.8) |
Class IV | 18 (1.0) | 17 (0.9) | 35 (1.0) | 16 (2.6) | 13 (2.2) | 29 (2.4) |
Blood pressure, n | 1798 | 1803 | 3601 | 616 | 584 | 1200 |
Systolic blood pressure (mmHg), mean (SD) | 121.0 (15.45) | 121.4 (15.6) | 121.2 (15.5) | 121.5 (16.4) | 121.5 (16.5) | 121.5 (16.4) |
Diastolic blood pressure (mmHg), mean (SD) | 72.5 (11.0) | 73.0 (10.5) | 72.8 (10.8) | 72.4 (11.4) | 73.3 (12.3) | 72.9 (11.8) |
Heart rate, n | 1798 | 1805 | 3603 | 616 | 585 | 1201 |
Mean (SD) bpm | 72.4 (12.8) | 72.7 (12.6) | 72.5 (12.7) | 74.6 (13.3) | 75.3 (14.2) | 74.9 (13.8) |
Atrial fibrillation, n (%) | 744 (41.4) | 809 (44.8) | 1553 (43.1) | 295 (47.9) | 290 (49.6) | 585 (48.7) |
Diabetes mellitus, n (%) | 864 (48.1) | 799 (44.2) | 1663 (46.1) | 312 (50.6) | 279 (47.7) | 591 (49.2) |
COPD, n (%) | 289 (16.1) | 318 (17.6) | 607 (16.8) | 119 (19.3) | 91 (15.6) | 210 (17.5) |
CAD, n (%) | 1079 (60.0) | 1009 (55.9) | 2088 (57.9) | 365 (59.3) | 351 (60.0) | 716 (59.6) |
History of smoking, n (%) | 1063 (59.1) | 1082 (59.9) | 2145 (59.5) | 346 (12.0) | 326 (55.7) | 672 (56.0) |
Time from diagnosis of any HF to randomization (years), mean (SD) | 5.2 (5.7) | 5.3 (5.6) | 5.2 (5.6) | 5.1 (5.8) | 5.2 (6.1) | 5.1 (5.9) |
Guideline‐directed medical therapy, n (%) | ||||||
ACE‐I or ARB | 1346 (74.9) | 1372 (76.0) | 2718 (75.4) | 426 (69.2) | 396 (67.7) | 822 (68.4) |
Sacubitril/valsartan | 263 (14.6) | 262 (14.5) | 525 (14.6) | 74 (12.0) | 85 (14.5) | 159 (13.2) |
Beta‐blocker | 1682 (93.5) | 1687 (93.4) | 3369 (93.5) | 566 (91.9) | 536 (91.6) | 1102 (91.8) |
MRA | 1283 (71.4) | 1334 (73.9) | 2617 (72.6) | 398 (64.6) | 374 (63.9) | 772 (64.3) |
Triple therapy | 1104 (61.4) | 1161 (64.3) | 2265 (62.8) | 316 (51.3) | 293 (50.1) | 609 (50.7) |
ICD | 495 (27.5) | 505 (28.0) | 1000 (27.7) | 166 (26.9) | 158 (27.0) | 324 (27.0) |
Biventricular pacing | 257 (14.3) | 251 (13.9) | 508 (14.1) | 94 (15.3) | 92 (15.7) | 186 (15.5) |
Laboratory results | ||||||
Haemoglobin, n | 1732 | 1742 | 3474 | 601 | 564 | 1165 |
Mean (SD) g/dL | 13.6 (1.9) | 13.6 (1.9) | 13.6 (1.9) | 12.8 (1.9) | 12.8 (2.0) | 12.8 (2.0) |
Haematocrit, n | 1732 | 1742 | 3474 | 601 | 564 | 1165 |
Mean (SD) % | 42.2 (5.84) | 42.4 (5.82) | 42.2 (5.83) | 40.1 (6.17) | 40.1 (6.12) | 40.1 (6.14) |
eGFR, mL/min/1.73 m2, n (%) | ||||||
≤30 | 122 (6.8) | 115 (6.4) | 237 (6.6) | 124 (20.1) | 117 (20.0) | 241 (20.1) |
>30 to ≤60 | 724 (40.3) | 715 (39.6) | 1439 (39.9) | 293 (47.6) | 295 (50.4) | 588 (49.0) |
>60 | 932 (51.8) | 965 (53.4) | 1897 (52.6) | 197 (32.0) | 170 (29.1) | 367 (30.6) |
Mean (SD) mL/min/1.73 m2 | 64.7 (26.6) | 65.3 (27.1) | 65.0 (26.8) | 51.9 (26.0) | 51.1 (25.0) | 51.5 (25.5) |
MAGGIC risk score, n | 1770 | 1780 | 3550 | 610 | 574 | 1184 |
Mean (SD) | 23.50 (6.4) | 23.40 (6.4) | 23.45 (6.4) | 27.40 (6.7) | 27.17 (6.6) | 27.29 (6.6) |
ACE‐I, angiotensin‐converting enzyme inhibitor; ARB, angiotensin receptor blocker; BMI, body mass index; bpm, beats per minute; CAD, coronary artery disease; COPD, chronic obstructive pulmonary disease; eGFR, estimated glomerular filtration rate; HF, heart failure; ICD, implantable cardioverter defibrillator; IQR, interquartile range; IV, intravenous; MAGGIC, Meta‐Analysis Global Group in Chronic Heart Failure; MRA, mineralocorticoid receptor antagonist; NT‐proBNP, N‐terminal pro‐brain natriuretic peptide; NYHA, New York Heart Association; SD, standard deviation.