Adjudicated baseline imaging characteristics (microhaemorrhages, atrophy, white matter hyperintensities and perivascular spaces) by small vessel disease score as determined by recruiting site
| Variable | N | All | SVD | Score | P value |
| Low | Moderate- severe | ||||
| Patients randomised | 363 | 99 | 264 | ||
| Microhaemorrhages | 196 | 39 (19.9) | 9 (20.9) | 30 (19.6) | 0.85 |
| No microhaemorrhages (%) | 39 | 0.18 | |||
| 1 | 9 (23.1) | 5 (55.6) | 4 (13.3) | ||
| 2 | 7 (17.9) | 3 (33.3) | 4 (13.3) | ||
| 3 | 5 (12.8) | 0 (0.0) | 5 (16.7) | ||
| 4 | 2 (5.1) | 0 (0.0) | 2 (6.7) | ||
| ≥5 | 15 (38.5) | 1 (11.1) | 14 (46.7) | ||
| Type of microhaemorrhages (%) | 39 | 0.61 | |||
| Lobar | 11 (28.2) | 2 (22.2) | 9 (30.0) | ||
| Deep | 16 (41.0) | 5 (55.6) | 11 (36.7) | ||
| Both | 12 (30.8) | 2 (22.2) | 10 (33.3) | ||
| Superficial siderosis present | 41 | 2 (4.9) | 0 (0.0) | 2 (6.3) | 1.00 |
| Siderosis focal | 2 (100.0) | 0 (0.0) | 2 (100.0) | 1.00 | |
| Siderosis disseminated | 0 (0.0) | 0 (0.0) | 0 (0.0) | – | |
| Siderosis location | 1.00 | ||||
| Left | 1 (50.0) | 0 (0.0) | 1 (50.0) | ||
| Right | 0 (0.0) | 0 (0.0) | 0 (0.0) | ||
| Both | 1 (50.0) | 0 (0.0) | 1 (50.0) | ||
| Atrophy (%) | |||||
| Brain volume reduction | 362 | 272 (75.1) | 63 (64.3) | 209 (79.2) | 0.0036 |
| Central brain tissue volume | 272 | 0.42 | |||
| Moderate | 199 (73.2) | 50 (79.4) | 149 (71.3) | ||
| Severe | 64 (23.5) | 11 (17.5) | 53 (25.4) | ||
| Cortical brain tissue volume | 272 | 0.12 | |||
| Moderate | 203 (74.6) | 43 (68.3) | 160 (76.6) | ||
| Severe | 5 (1.8) | 0 (0.0) | 5 (2.4) | ||
| WMH (%) | |||||
| WMH present | 362 | 342 (94.5) | 87 (88.8) | 255 (96.6) | 0.0038 |
| Anterior white matter lucency | 342 | ||||
| Adjoining ventricles | 116 (33.9) | 32 (36.8) | 84 (32.9) | 0.51 | |
| Covering ventricle to cortex | 56 (16.4) | 6 (6.9) | 50 (19.6) | 0.0057 | |
| Posterior white matter lucency | 342 | ||||
| Adjoining ventricles | 114 (33.3) | 27 (31.0) | 87 (34.1) | 0.60 | |
| Covering ventricle to cortex | 55 (16.1) | 10 (11.5) | 45 (17.6) | 0.18 | |
| Anterior and/or Posterior white matter lucency | 342 | ||||
| Adjoining ventricles | 136 (39.8) | 36 (41.4) | 100 (39.2) | 0.72 | |
| Covering ventricle to cortex | 68 (19.9) | 11 (12.6) | 57 (22.4) | 0.050 | |
| Periventricular WMH Fazekas score | 342 | <0.0001 | |||
| 1 | 131 (38.3) | 48 (55.2) | 83 (32.5) | ||
| 2 | 129 (37.7) | 32 (36.8) | 97 (38.0) | ||
| 3 | 80 (23.4) | 7 (8.0) | 73 (28.6) | ||
| Deep WMH Fazekas score | 342 | 0.0002 | |||
| 1 | 178 (52.0) | 59 (67.8) | 119 (46.7) | ||
| 2 | 102 (29.8) | 14 (16.1) | 88 (34.5) | ||
| 3 | 42 (12.3) | 5 (5.7) | 37 (14.5) | ||
| Periventricular and/or Deep WMH Fazekas score | 342 | <0.0001 | |||
| 1 | 123 (36.0) | 46 (52.9) | 77 (30.2) | ||
| 2 | 137 (40.1) | 34 (39.1) | 103 (40.4) | ||
| 3 | 82 (24.0) | 7 (8.0) | 75 (29.4) | ||
| Enlarged PVS (%), MRI only | 194 | ||||
| Enlarged PVS | 194 (100.0) | 43 (100.0) | 151 (100.0) | 1.00 | |
| Basal ganglia score | |||||
| ≤10 | 62 (32.0) | 23 (53.5) | 39 (25.8) | 0.0008 | |
| 11–20 | 74 (38.1) | 16 (37.2) | 58 (38.4) | ||
| 20–40 | 36 (18.6) | 4 (9.3) | 32 (21.2) | ||
| >40 | 22 (11.3) | 0 (0.0) | 22 (14.6) | ||
| Centrum semiovale score | |||||
| ≤10 | 30 (15.5) | 10 (23.3) | 20 (13.2) | 0.30 | |
| 11–20 | 52 (26.8) | 13 (30.2) | 39 (25.8) | ||
| 20–40 | 82 (42.3) | 15 (34.9) | 67 (44.4) | ||
| >40 | 30 (15.5) | 5 (11.6) | 25 (16.6) |
Data are number (%), median (IQR) or mean (SD). The number of participants with data is 363 unless stated.
PVS, perivascular spaces; WMH, white matter hyperintensities.