Table 1. Baseline Characteristics and MRI Findings by Cerebral Microbleed Status.
| Characteristic | No. (%)a | P value | |
|---|---|---|---|
| CMB positive (n = 395) | CMB negative (n = 3304) | ||
| Age, y | |||
| Mean (SD) | 69.5 (9.4) | 66.7 (9.8) | <.001 |
| <60 | 65 (16) | 800 (24) | <.001 |
| Male | 240 (61) | 2076 (63) | .42 |
| Race/ethnicity | |||
| White only | 202 (51) | 2218 (67) | <.001 |
| Black only | 11 (3) | 48 (1) | .05 |
| East Asian only | 151 (38) | 757 (23) | <.001 |
| Otherc (includes not reported and multiracial) | 31 (8) | 281 (9) | .66 |
| Global region | |||
| United States and Canada | 65 (16) | 544 (16) | >.99 |
| Latin America | 14 (4) | 246 (7) | .004 |
| Western Europe | 151 (38) | 1499 (45) | .007 |
| Eastern Europe | 20 (5) | 286 (9) | .014 |
| East Asia | 145 (37) | 729 (22) | <.001 |
| Medical history | |||
| Hypertension | 338 (86) | 2460 (74) | <.001 |
| Diabetes | 104 (26) | 813 (25) | .45 |
| Current tobacco use | 79 (20) | 686 (21) | .72 |
| Coronary artery disease | 29 (7) | 197 (6) | .28 |
| Heart failure | 10 (3) | 69 (2) | .56 |
| Cancer | 38 (10) | 328 (10) | .85 |
| Prior stroke or TIA | 89 (23) | 613 (19) | .06 |
| Renal dysfunction | 15 (4) | 114 (3) | .72 |
| Liver disease | 7 (2) | 56 (2) | .91 |
| History of GI bleeding | 9 (2) | 61 (2) | .55 |
| CHADS2, median (IQR) | 3.0 (3.0-4.0) | 3.0 (3.0-4.0) | <.001 |
| CHA2DS2-VASc, median (IQR) | 5.0 (4.0-6.0) | 4.0 (3.0-5.0) | <.001 |
| BMI, mean (SD) | 26.0 (4.8) | 27.0 (4.9) | <.001 |
| Blood pressure, mean (SD), mm Hg | |||
| Systolic | 135.3 (17.7) | 134.7 (16.7) | .51 |
| Diastolic | 78.7 (12.1) | 78.9 (11.1) | .75 |
| eGFR, mL/min per 1.73 m2 | 74.6 (20.3) | 78.2 (20.2) | <.001 |
| Qualifying ESUS | |||
| One cerebral hemisphere with cortical involvement | 185 (47) | 1810 (55) | .00 |
| One cerebral hemisphere, subcortical only | 74 (19) | 642 (19) | .74 |
| Brainstem only | 16 (4) | 167 (5) | .38 |
| Cerebellum only | 26 (7) | 277 (8) | .22 |
| Multiple locations | 94 (24) | 404 (12) | <.001 |
| Chronic infarct on imaging (in addition to index stroke) | 207 (53) | 1157 (35) | <.001 |
| Hemorrhagic transformation | 43 (11) | 268 (8) | .06 |
| Evidence of old macrohemorrhage | 21 (5) | 30 (1) | <.0001 |
| Oral antithrombotic therapy use before qualifying stroke | 0 | 0 | .55 |
| Statin use prior to randomization | 233 (59) | 2031 (61) | .34 |
| Treated with intravenous tPA for qualifying stroke | 47 (12) | 526 (16) | .04 |
| Treated with endovascular intervention | 18 (5) | 129 (4) | .53 |
| Function measures at randomization | |||
| EQ-5D, median (IQR) | 75.0 (60.0-90.0) | 80.0 (65.0-90.0) | .02 |
| MoCA, median (IQR) | 24.0 (21.0-27.0) | 25.0 (21.0-27.0) | .004 |
| NIHSS score at randomization, median (IQR) | 1.0 (0.0-2.0) | 1.0 (0.0-2.0) | >.99 |
| mRS at randomization, median (IQR) | 1.0 (0.0-2.0) | 1.0 (0.0-2.0) | .02 |
| LV ejection fraction | 63.4 (8.4) | 62.5 (7.9) | .07 |
| LV hypertrophy | 112 (28) | 794 (24) | .06 |
| Functional outcomes at 12 mo, median (IQR) | |||
| EQ-5D | 80.0 (70.0-90.0) | 80.0 (70.0-90.0) | .50 |
| MoCA | 25.0 (21.0-27.0) | 26.0 (22.0-28.0) | .005 |
Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); CHADS2, congestive heart failure, hypertension, age, diabetes, and stroke or transient ischemic attack; CHA2DS2-VASc, congestive heart failure, hypertension, age, diabetes, previous stroke or transient ischemic attack, and vascular disease; CMB, cerebral microbleed; eGFR, estimated glomerular filtration rate; EQ-5D, Euro-QoL 5D; and ESUS, embolic stroke of undetermined source; GI, gastrointestinal; IQR, interquartile range; LV, left ventricular; MoCA, Montreal Cognitive Assessment; MRI, magnetic resonance imaging; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; TIA, transient ischemic attack; tPA, tissue plasminogen activator.
Values are listed as No. (%) unless otherwise specified.