Table 1 Baseline characteristic levels according to the primary outcome
Variable | Overall (n = 587) | Patients without primary outcome (n = 276) | Patients with primary outcome (n = 311) | p-value* | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
N | Mean ± SD/n (%) | Median (Q1–Q3) | N | Mean ± SD/n (%) | Median (Q1–Q3) | N | Mean ± SD/n (%) | Median (Q1–Q3) | ||
Study intervention group | 587 | 276 | 311 | 0.069 | ||||||
Control | 289 (49.2%) | 147 (53.3%) | 142 (45.7%) | |||||||
ASV | 298 (50.8%) | 129 (46.7%) | 169 (54.3%) | |||||||
Age (years) | 587 | 69.5 ± 9.8 | 71 (63–77) | 276 | 68.1 ± 9.8 | 70 (62–76) | 311 | 70.8 ± 9.6 | 72 (65–78) | 0.0005 |
Male | 587 | 527 (89.8%) | 276 | 238 (86.2%) | 311 | 289 (92.9%) | 0.009 | |||
Body mass index (kg/m2) | 582 | 28.7 ± 5.0 | 28.1 (25.2–31.1) | 272 | 29.1 ± 5.2 | 28.4 (25.4–31.7) | 310 | 28.4 ± 4.8 | 27.8 (25.1–30.7) | 0.13 |
NYHA class III/IV | 583 | 421 (72.2%) | 273 | 180 (65.9%) | 310 | 241 (77.7%) | 0.002 | |||
LVEF (%) | 444 | 33.5 ± 7.7 | 35 (29–40) | 217 | 35.4 ± 7.2 | 36 (30–40) | 227 | 31.8 ± 7.6 | 31 (25–38) | < 0.0001 |
Diabetes | 583 | 243 (41.7%) | 272 | 88 (32.4%) | 311 | 155 (49.8%) | < 0.0001 | |||
Ischemic HF | 572 | 326 (57.0%) | 271 | 140 (51.7%) | 301 | 186 (61.8%) | 0.018 | |||
Systolic blood pressure (mmHg) | 577 | 124.3 ± 19.9 | 120 (110–140) | 270 | 127.1 ± 19.3 | 125 (110–140) | 307 | 121.8 ± 20.1 | 120 (110–135) | 0.0005 |
Left bundle-branch-block | 573 | 150 (26.2%) | 268 | 58 (21.6%) | 305 | 92 (30.2%) | 0.022 | |||
Atrial fibrillation | 574 | 176 (30.7%) | 268 | 69 (25.7%) | 306 | 107 (35.0%) | 0.018 | |||
Cardiac device | 587 | 313 (53.3%) | 276 | 119 (43.1%) | 311 | 194 (62.4%) | < 0.0001 | |||
Hemoglobin (g/dL) | 577 | 13.9 ± 1.6 | 14.1 (12.9–15.0) | 272 | 14.2 ± 1.4 | 14.3 (13.3–15.2) | 305 | 13.7 ± 1.7 | 13.8 (12.6–14.9) | 0.001 |
eGFR CKD-EPI formula (mL/min/1.73m2) | 570 | 57.1 ± 21.0 | 55.8 (40.6–72.8) | 266 | 63.0 ± 19.8 | 63.1 (48.1–78.1) | 304 | 52.0 ± 20.7 | 50.7 (35.1–65.3) | < 0.0001 |
6-min walk distance (meters) | 558 | 329.0 ± 125.0 | 340 (250–423) | 262 | 369.6 ± 109.5 | 380 (300–450) | 296 | 293.0 ± 127.0 | 300 (200–382) | < 0.0001 |
ACEI or ARB | 587 | 540 (92.0%) | 276 | 260 (94.2%) | 311 | 280 (90.0%) | 0.069 | |||
Beta-blocker | 587 | 537 (91.5%) | 276 | 255 (92.4%) | 311 | 282 (90.7%) | 0.55 | |||
Aldosterone antagonist | 587 | 293 (49.9%) | 276 | 137 (49.6%) | 311 | 156 (50.2%) | 0.93 | |||
Diuretic | 587 | 509 (86.7%) | 276 | 219 (79.3%) | 311 | 290 (93.2%) | < 0.0001 | |||
Cardiac glycoside | 587 | 150 (25.6%) | 276 | 55 (19.9%) | 311 | 95 (30.5%) | 0.003 | |||
Antiarrhythmic drug | 587 | 101 (17.2%) | 276 | 35 (12.7%) | 311 | 66 (21.2%) | 0.006 | |||
Epworth Sleep Scale score | 586 | 6.9 ± 4.4 | 6 (4–9) | 275 | 6.5 ± 4.2 | 6 (3–9) | 311 | 7.2 ± 4.5 | 6 (4–10) | 0.073 |
AHI (n events/hr) | 586 | 30.3 ± 12.7 | 27 (20–38) | 276 | 31.4 ± 13.4 | 29 (21–39) | 310 | 29.2 ± 12.0 | 27 (19–38) | 0.070 |
Central apnea index/total AHI (%) | 586 | 47.4 ± 29.4 | 48 (22–73) | 276 | 45.9 ± 30.2 | 45 (19–73) | 310 | 48.8 ± 28.6 | 50 (25–74) | 0.24 |
Central AHI/total AHI (%) | 586 | 80.7 ± 15.0 | 84 (69–93) | 276 | 80.6 ± 15.5 | 84 (68—93) | 310 | 80.8 ± 14.5 | 83 (70–93) | 0.95 |
Oxygen desaturation index | 585 | 33.2 ± 17.4 | 31 (21–44) | 275 | 32.9 ± 16.7 | 31 (21–44) | 310 | 33.4 ± 18.1 | 32 (20–44) | 0.87 |
Average oxygen saturation (%) | 587 | 92.8 ± 2.4 | 93 (92–94) | 276 | 93.1 ± 2.2 | 93 (92—95) | 311 | 92.5 ± 2.4 | 93 (91—94) | 0.0006 |
Minimum oxygen saturation (%) | 586 | 80.9 ± 6.6 | 82 (78–85) | 276 | 81.6 ± 6.5 | 83 (78–86) | 310 | 80.2 ± 6.7 | 82 (77–85) | 0.004 |
Time with oxygen saturation < 90% (min) | 584 | 48.4 ± 63.6 | 22 (5–65) | 276 | 43.0 ± 64.0 | 17 (3–54) | 308 | 53.3 ± 62.9 | 29 (8–76) | 0.0004 |
Cheyne-stokes respiration | 506 | 241 | 265 | 0.68 | ||||||
< 20% | 106 (20.9%) | 51 (21.2%) | 55 (20.8%) | |||||||
20–50% | 191 (37.7%) | 95 (39.4%) | 96 (36.2%) | |||||||
> 50% | 209 (41.3%) | 95 (39.4%) | 114 (43.0%) | |||||||
NT-proBNP (pg/mL) | 583 | 2717 ± 4691 | 1400 (605–3036) | 273 | 1788 ± 3523 | 881 (354–1828) | 310 | 3536 ± 5392 | 2044 (975–3757) | < 0.0001 |
Primary outcome | 587 | 311 (53.0%) | 276 | 0 (0.0%) | 311 | 311 (100.0%) | < 0.0001 | |||
Time to primary outcome (years) | 587 | 2.3 ± 1.8 | 2.1 (0.7–3.6) | 276 | 3.3 ± 1.8 | 3.3 (2.1–4.7) | 311 | 1.5 ± 1.3 | 1.0 (0.4–2.2) | < 0.0001 |
Time to follow-up (years) | 587 | 3.1 ± 1.8 | 3.0 (1.9–4.4) | 276 | 3.3 ± 1.8 | 3.3 (2.1–4.7) | 311 | 2.9 ± 1.7 | 2.7 (1.5–4.2) | 0.003 |