Table 1. Demographic and Clinical Characteristics of the Patients at Baseline.
| Characteristic | No. (%) | |
|---|---|---|
| Methylprednisolone (n = 839) | Placebo (n = 841) | |
| Age, median (IQR), y | 68.0 (59.0-75.0) | 69.0 (59.0-77.0) |
| Sex | ||
| Female | 359 (42.8) | 368 (43.8) |
| Male | 480 (57.2) | 473 (56.2) |
| Medical historya | ||
| Hypertension | 504 (60.1) | 523 (62.2) |
| Atrial fibrillation | 348 (41.5) | 353 (42.0) |
| Hyperlipidemia | 267 (31.8) | 245 (29.1) |
| Diabetes | 170 (20.3) | 152 (18.1) |
| Coronary heart disease | 147 (17.5) | 169 (20.1) |
| Cerebral ischemia | 136 (16.2) | 117 (13.9) |
| Valvular heart disease | 114 (13.6) | 115 (13.7) |
| Intracranial hemorrhage | 12 (1.4) | 10 (1.2) |
| Transient ischemic attack | 6 (0.7) | 4 (0.5) |
| Smoking (current) | 236 (28.1) | 241 (28.7) |
| Prestroke modified Rankin Scale scoreb | ||
| 0 | 803 (95.7) | 817 (97.1) |
| 1 | 28 (3.3) | 14 (1.7) |
| 2 | 6 (0.7) | 8 (1.0) |
| 3 | 1 (0.1) | 1 (0.1) |
| 4 | 1 (0.1) | 1 (0.1) |
| Glucose level at hospital arrival median (IQR), mmol/L | 7.2 (6.2-8.9) [n = 736] | 7.0 (6.0-8.6) [n = 736] |
| Baseline NIHSS score, median (IQR)c | 19.0 (16.0-21.0) | 19.0 (16.0-21.0) |
| Baseline ASPECTS, median (IQR)d | 6.0 (4.0-7.0) | 6.0 (4.0-7.0) |
| TOAST etiologye | n = 838 | |
| Cardioembolic | 422 (50.4) | 393 (46.7) |
| Large artery atherosclerosis | 302 (36.0) | 334 (39.7) |
| Others | 32 (3.8) | 41 (4.9) |
| Unknown | 82 (9.8) | 73 (8.7) |
| Occlusion site on CT or MR angiography | ||
| Intracranial internal carotid artery | 286 (34.1) | 293 (34.8) |
| M1 middle cerebral artery segment | 452 (53.9) | 426 (50.7) |
| M2 middle cerebral artery segment | 99 (11.8) | 122 (14.5) |
| Otherf | 2 (0.2) | 0 |
| Intravenous thrombolysis | 295 (35.2) | 333 (39.6) |
| Time from last known well, median (IQR), h | ||
| To puncture | 5.8 (3.9-10.2) | 6.0 (4.0-9.8) |
| To randomization | 5.9 (4.0-10.2) | 6.1 (4.0-9.8) |
| To recanalization | 7.2 (5.2-11.6) | 7.4 (5.2-11.5) [n = 840] |
| Time from randomization to initial treatment, median (IQR), min | 8.0 (6.0-14.0) | 8.0 (6.0-13.0) [n = 839] |
| Blood pressure at hospital arrival, median (IQR), mm Hg | ||
| Systolic | 142.0 (126.0-160.0) | 145.0 (127.0-160.0) |
| Diastolic | 83.0 (74.0-92.0) | 84.0 (75.0-94.0) |
Abbreviations: ASPECTS, Alberta Stroke Program Early CT Score; CT, computed tomography; MR, magnetic resonance; NIHSS, National Institutes of Health Stroke Scale; TOAST, Trial of Org 10172 in Acute Stroke Treatment.
SI conversion factor: To convert glucose to mg/dL, divide by 0.0555.
Comorbidities based on family or patient report.
Scores on the mRS of functional disability range from 0 (no symptoms) to 6 (death).
Scores on the NIHSS range from 0 to 42, with higher scores indicating more severe neurologic deficit.
The ASPECTS is an imaging measure of the extent of ischemic stroke. Scores range from 0 to 10, with higher scores indicating a smaller infarct core. Listed are values for the core laboratory assessment. Data were missing for 3 patients in the methylprednisolone group and 3 patients in the placebo group.
The TOAST classification system is a widely used method for classifying ischemic stroke and transient ischemic attack (TIA). It divides ischemic stroke and TIA into 5 subtypes based on their likely causes: large artery atherosclerosis, cardioembolism, small-artery occlusion, other determined etiology, and undetermined etiology. Data were missing for 1 patient in the methylprednisolone group.
One patient had a basilar artery occlusion and 1 patient had an anterior cerebral artery occlusion in the methylprednisolone group.