Table 4

Adjudicated baseline imaging characteristics (microhaemorrhages, atrophy, white matter hyperintensities and perivascular spaces) by small vessel disease score as determined by recruiting site

VariableNAllSVDScoreP value
LowModerate- severe
Patients randomised36399264
Microhaemorrhages19639 (19.9)9 (20.9)30 (19.6)0.85
No microhaemorrhages (%)390.18
 19 (23.1)5 (55.6)4 (13.3)
 27 (17.9)3 (33.3)4 (13.3)
 35 (12.8)0 (0.0)5 (16.7)
 42 (5.1)0 (0.0)2 (6.7)
 ≥515 (38.5)1 (11.1)14 (46.7)
Type of microhaemorrhages (%)390.61
 Lobar11 (28.2)2 (22.2)9 (30.0)
 Deep16 (41.0)5 (55.6)11 (36.7)
 Both12 (30.8)2 (22.2)10 (33.3)
Superficial siderosis present412 (4.9)0 (0.0)2 (6.3)1.00
Siderosis focal2 (100.0)0 (0.0)2 (100.0)1.00
Siderosis disseminated0 (0.0)0 (0.0)0 (0.0)
Siderosis location1.00
 Left1 (50.0)0 (0.0)1 (50.0)
 Right0 (0.0)0 (0.0)0 (0.0)
 Both1 (50.0)0 (0.0)1 (50.0)
Atrophy (%)
 Brain volume reduction362272 (75.1)63 (64.3)209 (79.2)0.0036
 Central brain tissue volume2720.42
  Moderate199 (73.2)50 (79.4)149 (71.3)
  Severe64 (23.5)11 (17.5)53 (25.4)
 Cortical brain tissue volume2720.12
  Moderate203 (74.6)43 (68.3)160 (76.6)
  Severe5 (1.8)0 (0.0)5 (2.4)
WMH (%)
 WMH present362342 (94.5)87 (88.8)255 (96.6)0.0038
 Anterior white matter lucency342
  Adjoining ventricles116 (33.9)32 (36.8)84 (32.9)0.51
  Covering ventricle to cortex56 (16.4)6 (6.9)50 (19.6)0.0057
 Posterior white matter lucency342
  Adjoining ventricles114 (33.3)27 (31.0)87 (34.1)0.60
  Covering ventricle to cortex55 (16.1)10 (11.5)45 (17.6)0.18
 Anterior and/or Posterior white matter lucency342
  Adjoining ventricles136 (39.8)36 (41.4)100 (39.2)0.72
  Covering ventricle to cortex68 (19.9)11 (12.6)57 (22.4)0.050
 Periventricular WMH Fazekas score342<0.0001
  1131 (38.3)48 (55.2)83 (32.5)
  2129 (37.7)32 (36.8)97 (38.0)
  380 (23.4)7 (8.0)73 (28.6)
 Deep WMH Fazekas score3420.0002
  1178 (52.0)59 (67.8)119 (46.7)
  2102 (29.8)14 (16.1)88 (34.5)
  342 (12.3)5 (5.7)37 (14.5)
  Periventricular and/or
  Deep WMH Fazekas score
342<0.0001
  1123 (36.0)46 (52.9)77 (30.2)
  2137 (40.1)34 (39.1)103 (40.4)
  382 (24.0)7 (8.0)75 (29.4)
Enlarged PVS (%), MRI only194
 Enlarged PVS194 (100.0)43 (100.0)151 (100.0)1.00
 Basal ganglia score
  ≤1062 (32.0)23 (53.5)39 (25.8)0.0008
  11–2074 (38.1)16 (37.2)58 (38.4)
  20–4036 (18.6)4 (9.3)32 (21.2)
  >4022 (11.3)0 (0.0)22 (14.6)
 Centrum semiovale score
  ≤1030 (15.5)10 (23.3)20 (13.2)0.30
  11–2052 (26.8)13 (30.2)39 (25.8)
  20–4082 (42.3)15 (34.9)67 (44.4)
  >4030 (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.