Table 1:
Baseline characteristics of patients by patent foramen ovale identified by transthoracic or transoesophageal echocardiography, or both
| PFO detected (n=534) | PFO not detected (n=6675) | |
|---|---|---|
| Age, years | 64·6 (9·2) | 67·1 (9·8) |
| Age <60 years | 162 (30%) | 1552 (23%) |
| Sex | ||
| Men | 336 (63%) | 4096 (61%) |
| Women | 198 (36%) | 2579 (39%) |
| Race | ||
| White only | 367 (69%) | 4847 (73%) |
| Black only | 4 (1%) | 107 (2%) |
| East Asian only | 102 (19%) | 1311 (20%) |
| Others (includes not reported or multiracial) | 61 (11%) | 410 (6%) |
| BMI, kg/m2 | 26·9 (5·0) | 27·3 (5·0) |
| Weight, kg | 77·0 (16·4) | 76·1 (16·5) |
| Mean estimated glomerular filtration rate, mL/min per 1·73 m2 | 78·4 (19·3) | 78·6 (20·6) |
| Medical history | ||
| Hypertension | 359 (67%) | 5222 (78%) |
| Diabetes | 96 (18%) | 1709 (26%) |
| Current tobacco use | 105 (20%) | 1377 (21%) |
| Coronary artery disease | 24 (4%) | 447 (7%) |
| Heart failure | 8 (1%) | 230 (3%) |
| Cancer | 33 (6%) | 586 (9%) |
| Previous stroke or TIA | 93 (17%) | 1168 (17%) |
| Global region | ||
| USA and Canada | 96 (18%) | 820 (12%) |
| Latin America | 30 (6%) | 716 (11%) |
| Western Europe | 270 (51%) | 2810 (42%) |
| Eastern Europe | 37 (7%) | 1081 (16%) |
| East Asia | 101 (19%) | 1248 (19%) |
| Qualifying stroke | ||
| Clinical TIA with imaging-confirmed infarction as qualifying event | 70 (13%) | 450 (7%) |
| Arterial territory of qualifying stroke | ||
| Anterior circulation | 377 (71%) | 4808 (72%) |
| Posterior circulation | 176 (33%) | 2091 (31%) |
| Location of qualifying stroke | ||
| Single location | ||
| Cerebral hemisphere with cortical involvement | 318 (60%) | 3715 (56%) |
| Cerebral hemisphere, subcortical only | 78 (15%) | 1440 (22%) |
| Brainstem only | 22 (4%) | 309 (5%) |
| Cerebellum only | 49 (9%) | 512 (8%) |
| Multiple locations | 67 (13%) | 694 (10%) |
| Chronic infarct on imaging (in addition to index stroke) | 137 (26%) | 2212 (33%) |
| Aspirin use before qualifying stroke | 79 (15%) | 1174 (18%) |
| Statin use before randomisation | 324 (61%) | 4107 (62%) |
| Treated with intravenous tPA for qualifying stroke | 121 (23%) | 1135 (17%) |
| Treated with endovascular intervention for qualifying stroke | 29 (5%) | 271 (4%) |
| NIHSS score at randomisation | 0·0 (0·0–1·0) | 1·0 (0·0−2·0) |
| NIHSS score ≤5 | 524 (98%) | 6398 (96%) |
| Modified Rankin Scale (mRS) score at randomisation | ||
| mRS 0 or 1 | 390 (73%) | 4278 (64%) |
| mRS 2 | 108 (20%) | 1563 (23%) |
| mRS ≥3 | 36 (7%) | 833 (12%) |
| MoCA score at randomisation | 26·0 (23·0–28·0) | 24·0 (21·0–27·0) |
| Time from qualifying stroke to randomisation, days | 39·5 (15·0–98·0) | 36·0 (14·0–87·0) |
| Extracranial vascular imaging completed | ||
| CT angiography | 228 (43%) | 2511 (38%) |
| Magnetic resonance angiography | 246 (46%) | 2132 (32%) |
| Carotid ultrasound | 302 (57%) | 4248 (64%) |
| Conventional angiography | 9 (2%) | 112 (2%) |
| Intracranial vascular imaging completed | 483 (90%) | 5158 (77%) |
| Duration of cardiac rhythm monitoring ≥48 h | 254 (48%) | 2179 (33%) |
Data are n (%), mean (SD), or median (IQR). PFO=patent foramen ovale. BMI=body-mass index. TIA=transient ischaemic stroke. tPA=tissue plasminogen activator. NIHSS=National Institutes of Health Stroke Scale/Score. MoCA=Montreal Cognitive Assessment.