Table 1.
Baseline characteristics of the complete NAVIGATE-ESUS study population
| Characteristic | N with Data | Summary (N = 7214) |
|---|---|---|
| Age, years (mean ± s.d.) | 7213 | 66.9 ± 9.8 |
| Age<60 years | 7213 | 1716 (24) |
| Male sex | 7213 | 4437 (62) |
| Race: | ||
| White only | 7213 | 5219 (72) |
| Black only | 7213 | 111 (2) |
| East Asian only | 7213 | 1414 (20) |
| Others (includes not reported/multiracial) | 7213 | 470 (7) |
| BMI, kg/m2 (mean ± s.d.) | 7182 | 27.2 ± 5.0 |
| <25 kg/m2 | 7182 | 2505 (35) |
| ≥25–<30 kg/m2 | 7182 | 2970 (41) |
| ≥30 kg/m2 | 7182 | 1708 (24) |
| <30 kg/m2 | 7182 | 5475 (76) |
| ≥30 kg/m2 | 7182 | 1708 (24) |
| Weight, kg (mean ± s.d.) | 7189 | 76.2 ± 16.5 |
| <70 kg | 7189 | 2535 (35) |
| 70–90 kg | 7189 | 3479 (48) |
| >90 kg | 7189 | 1176 (16) |
| <50 kg | 7189 | 199 (3) |
| 50–100 kg | 7189 | 6467 (90) |
| >100 kg | 7189 | 524 (7) |
| Estimated glomerular filtration rate (eGFR), mL/min per 1.73 m2 | 7209 | 78.6 ± 20.6 |
| <50 mL/min | 7209 | 419 (6) |
| 50–80 mL/min | 7209 | 3531 (49) |
| >80 mL/min | 7209 | 3260 (45) |
| Medical history: | ||
| Hypertension | 7213 | 5586 (77) |
| Diabetes mellitus | 7213 | 1805 (25) |
| Current tobacco use | 7212 | 1484 (21) |
| Coronary artery disease | 7213 | 473 (7) |
| Heart failure | 7213 | 238 (3) |
| Cancer | 7213 | 620 (9) |
| Bioprosthetic heart valve | 7213 | 21 (0) |
| Prior stroke or TIA | 7213 | 1263 (18) |
| Global region: | ||
| U.S.A. and Canada | 7213 | 918 (13) |
| Latin America | 7213 | 746 (10) |
| Western Europe | 7213 | 3081 (43) |
| Eastern Europe | 7213 | 1119 (16) |
| East Asia | 7213 | 1350 (19) |
| Qualifying stroke: | ||
| Clinical TIA with imaging-confirmed infarction as qualifying event: | 7213 | 521 (7) |
| Arterial territory of qualifying stroke: | ||
| Anterior circulation | 7213 | 5187 (72) |
| Posterior circulation | 7213 | 2269 (31) |
| Location of qualifying stroke: | ||
| Single Location: | ||
| Cerebral hemisphere with cortical involvement | 7213 | 4036 (56) |
| Cerebral hemisphere, subcortical only | 7213 | 1518 (21) |
| Brainstem only | 7213 | 331 (5) |
| Cerebellum only | 7213 | 562 (8) |
| Multiple Locations: | 7213 | 762 (11) |
| Chronic infarct on imaging (in addition to index stroke) | 7212 | 2350 (33) |
| Aspirin use prior to qualifying stroke | 7213 | 1247 (17) |
| Statin use prior to randomization | 7213 | 4425 (61) |
| Treated with intravenous tPA for qualifying stroke | 7213 | 1255 (17) |
| Treated with endovascular intervention for qualifying stroke | 7213 | 300 (4) |
| NIHSS score at randomization (median, IQR) | 7209 | 1.0 (0.0, 2.0) |
| NIHSS score ≤5 | 7209 | 6927 (96) |
| Modified Rankin Scale (mRS) at randomization: | ||
| mRS 0 or 1 | 7212 | 4670 (65) |
| mRS 2 | 7212 | 1673 (23) |
| mRS ≥3 | 7212 | 870 (12) |
| MoCA score at randomization (median, IQR) | 6531 | 25.0 (21.0, 27.0) |
| Time from qualifying stroke to randomization, days (median, IQR) | 7213 | 37.0 (14.0, 88.0) |
| Extracranial vascular imaging completed: | ||
| CTA | 7211 | 2743 (38) |
| MRA | 7212 | 2380 (33) |
| Carotid ultrasound | 7212 | 4553 (63) |
| Conventional angiography | 5583 | 121 (2) |
| Intracranial vascular imaging completed: | ||
| CTA but not MRA or Transcranial Doppler | 7213 | 2586 (36) |
| MRA but not Transcranial Doppler | 7213 | 2201 (31) |
| Transcranial Doppler | 7213 | 857 (12) |
| None | 7213 | 1570 (22) |
| Transthoracic echocardiography: | 7213 | 6885 (95) |
| Left atrial diameter, cm (mean ± s.d.) | 4009 | 3.8 ± 1.4 |
| Left ventricular ejection fraction, % (mean ± s.d.) | 5761 | 62.3 ± 8.1 |
| Transesophageal echocardiography | 7211 | 1382 (19) |
| Patent foramen ovale present | 1382 | 372 (27) |
| Duration of cardiac rhythm monitoring ≥48 hours | 7207 | 2438 (34) |
Abbreviations: BMI, body mass index; CTA, computed tomographic angiography; IQR, interquartile range; MoCA, Montreal Cognitive Assessment; MRA, magenetic resonance angiography; NAVIGATE-ESUS, New Approach Rivaroxaban Inhibition of Factor Xa in a Global trial vs. ASA to Prevent Embolism in Embolic Stroke of Undetermined Source; NIHSS, National Institutes of Health Stroke Scale; SD, standard deviation; TIA, transient ischemic attack; tPA, tissue plasminogen activator.