Table 1.
Clinical and echocardiographic characteristics of the ENGAGE AF-TIMI 48 echocardiographic substudy in the overall population and stratified according to left atrial structure and function
| Overall population (n = 971) | Normal LA volume (LAVi <35 mL/m2) (n = 591) | Enlarged LA volume (LAVi ≥35 mL/m2) (n = 380) | P-value | Normal LA function (LAEF >45%) (n = 252) | Reduced LA function (LAEF ≤45%) (n = 717) | P-value | |
|---|---|---|---|---|---|---|---|
| Age, years | 71 ± 9.4 | 71.2 ± 9.5 | 72.7 ± 9.3 | 0.02 | 71.8 ± 9.4 | 71.8 ± 9.4 | 0.94 |
| Women | 334 (34.4%) | 198 (33.5%) | 136 (35.8%) | 0.46 | 94 (37.3%) | 239 (33.3%) | 0.25 |
| CHA2DS2-VASc | 0.08 | 0.96 | |||||
| 2 | 70 (7.2%) | 46 (7.8%) | 24 (6.3%) | 18 (7.1%) | 52 (7.3%) | ||
| 3 | 205 (21.1%) | 138 (23.4%) | 67 (17.6%) | 51 (20.2%) | 154 (21.5%) | ||
| 4 | 288 (29.7%) | 181 (30.6%) | 107 (28.2%) | 81 (32.1 %) | 207 (28.9%) | ||
| ≥5 | 408 (42.0%) | 226 (38.2%) | 182 (47.9%) | 102 (41.0%) | 304 (43.0%) | ||
| History of heart failure | 530 (54.6%) | 282 (47.7%) | 248 (65.3%) | <0.001 | 120 (47.6%) | 410 (57.2%) | 0.009 |
| NYHA class I–II | 382 (39.4%) | 204 (34.5%) | 178 (46.8%) | <0.001 | 82 (32.5%) | 300 (41.8%) | 0.009 |
| NYHA class III–IV | 117 (12.0%) | 56 (9.5%) | 61 (16.1%) | 0.002 | 28 (11.1%) | 89 (12.4%) | 0.59 |
| Sinus rhythm at the time of echocardiography | 321 (33.1%) | 265 (44.8%) | 56 (14.7%) | <0.001 | 132 (52.4%) | 187 (26.1%) | <0.001 |
| Diabetes | 346 (35.6%) | 220 (37.2%) | 126 (33.2%) | 0.2 | 90 (35.7%) | 256 (35.7%) | >0.99 |
| Dyslipidaemia | 623 (64.2%) | 398 (67.3%) | 225 (59.2%) | 0.01 | 177 (70.2%) | 446 (62.2%) | 0.022 |
| History of hypertension | 917 (94.4%) | 555 (93.9%) | 362 (95.3%) | 0.37 | 232 (92.1%) | 683 (95.3%) | 0.06 |
| History of myocardial revascularization | 199 (20.5%) | 123 (20.8%) | 76 (20.0%) | 0.75 | 47 (18.7%) | 152 (21.2%) | 0.4 |
| Current smoking | 100 (10.3%) | 70 (11.8%) | 30 (7.9%) | 0.048 | 39 (15.5%) | 61 (8.5%) | 0.002 |
| BMI, kg/m2 | 29.9 ± 6.3 | 30.3 ± 6.6 | 29.3 ± 5.9 | 0.011 | 29.3 ± 6.4 | 30.2 ± 6.3 | 0.06 |
| Heart rate, b.p.m. | 73 ± 15 | 72.4 ± 15.2 | 75.0 ± 13.4 | 0.008 | 72.5 ± 14.5 | 73.8 ± 14.6 | 0.22 |
| Systolic blood pressure, mmHg | 130.3 ± 17.1 | 131.0 ± 17.5 | 129.2 ± 16.4 | 0.11 | 130.1 ± 17.5 | 130.3 ± 16.9 | 0.87 |
| Treatment with β-blockers | 657 (67.7%) | 393 (66.5%) | 264 (69.5%) | 0.33 | 159 (63.1%) | 497 (69.3%) | 0.07 |
| Treatment with ACEi or ARB | 565 (58.2%) | 319 (54.0%) | 246 (64.7%) | <0.001 | 137 (54.4%) | 427 (59.6%) | 0.15 |
| Treatment with MRA | 573 (59.0%) | 324 (54.8%) | 249 (65.5%) | <0.001 | 140 (55.6%) | 432 (60.3%) | 0.19 |
| Treatment with diuretics | 579 (59.6%) | 320 (54.1%) | 259 (68.2%) | <0.001 | 124 (49.2%) | 454 (63.3%) | <0.001 |
| Treatment with CCB | 287 (29.6%) | 180 (30.5%) | 107 (28.2%) | 0.44 | 87 (34.5%) | 199 (27.8%) | 0.043 |
| AF pattern at randomization | <0.001 | <0.001 | |||||
| Paroxysmal | 319 (32.9%) | 242 (40.9%) | 77 (20.3%) | 125 (49.6%) | 192 (26.8%) | ||
| Persistent | 202 (20.8%) | 130 (22.0%) | 72 (18.9%) | 42 (16.7%) | 160 (22.3%) | ||
| Permanent | 450 (46.3%) | 219 (37.1%) | 231 (60.8%) | 85 (33.7%) | 365 (50.9%) | ||
| History of AF ablation | 59 (6.1%) | 43 (7.3%) | 16 (4.2%) | 0.050 | 17 (6.7%) | 42 (5.9%) | 0.61 |
| CrCl, mL/min | 77 ± 32 | 79.9 ± 32.8 | 72.2 ± 30.9 | <0.001 | 76.4 ± 35.1 | 77.1 ± 31.2 | 0.78 |
| Treatment with anti-arrhythmic drugs | 186 (19.2%) | 136 (23.0%) | 50 (13.2%) | <0.001 | 64 (25.4%) | 121 (16.9%) | 0.003 |
| Treatment with ASA | 292 (30.1%) | 198 (33.5%) | 94 (24.7%) | 0.004 | 82 (32.5%) | 209 (29.1%) | 0.31 |
| Allocated therapy | 0.48 | 0.74 | |||||
| Warfarin | 327 (33.7%) | 207 (35.0%) | 120 (31.6%) | 84 (33.3%) | 242 (33.8%) | ||
| Edoxaban (low-dose regimen) | 337 (34.7%) | 204 (34.5%) | 133 (35.0%) | 92 (36.5%) | 244 (34.0%) | ||
| Edoxaban (high-dose regimen) | 307 (31.6%) | 180 (30.5%) | 127 (33.4%) | 76 (30.2%) | 231 (32.2%) | ||
| LVEF, % | 54.3 ± 10.5 | 56.4 ± 8.2 | 51.2 ± 12.7 | <0.001 | 57.1 ± 7.8 | 53.4 ± 11.1 | <0.001 |
| LVEF <50% | 217 (22.3%) | 90 (15.2%) | 127 (33.4%) | <0.001 | 37 (14.7%) | 180 (25.1%) | <0.001 |
| LVEDVi, mL/m2 | 58 ± 13 | 55.6 ± 10 | 62.6 ± 15.5 | <0.001 | 55.9 ± 10.5 | 59.2 ± 13.6 | <0.001 |
| LVMi, g/m2 | 76 ± 26 | 71.1 ± 21.4 | 83.5 ± 30.8 | <0.001 | 73.5 ± 28.1 | 76.8 ± 25.5 | 0.09 |
| LAVi, mL/m2 | 34 ± 11 | 27.4 ± 4.8 | 44.6 ± 9.7 | by design | 27.7 ± 7.4 | 36.5 ± 11.1 | <0.001 |
| LAEF, % | 37.7 ± 10 | 41.5 ± 8.8 | 31.8 ± 8.8 | <0.001 | 50.1 ± 4.0 | 33.3 ± 7.5 | by design |
| LAEi, % | 65 ± 28 | 74.9 ± 27.1 | 49.1 ± 20.4 | <0.001 | 101.7 ± 18.3 | 51.8 ± 16.5 | <0.001 |
| E/e′ average | 11.7 ± 4.6 | 11.5 ± 4.5 | 12.1 ± 4.9 | 0.042 | 11.4 ± 4.2 | 11.9 ± 4.8 | 0.19 |
| MR (moderate/severe) | 99 (10.8%) | 31 (5.6%) | 68 (18.7%) | <0.001 | 13 (5.5%) | 86 (12.6%) | 0.002 |
| RVSP, mmHga | 23.7 ± 7.7 | 22.6 ± 6.4 | 25.0 ± 8.9 | <0.001 | 22.0 ± 6.3 | 24.2 ± 8.0 | 0.004 |
Data are expressed as count (percentage) or mean ± standard deviation.
ACEi, angiotensin-converting enzyme inhibitor; AF, atrial fibrillation; ARB, angiotensin II receptor blocker; ASA, aspirin; BMI, body mass index; CCB, calcium channel blocker; CrCl creatinine clearance; LA, left atrial; LAEF, left atrial emptying fraction; LAEi, left atrial expansion index; LAVi, left atrial volume index; LVEDVi, left ventricular end-diastolic volume index; LVEF, left ventricular ejection fraction; LVMi, left ventricular mass index; MR, mitral regurgitation; MRA, mineralocorticoid receptor antagonist; NYHA, New York Heart Association; RVSP, right ventricular systolic pressure.
a
RVSP was measurable in 587 of 971 patients (60.5%).