Table 1. Baseline Characteristics of the Patients Included in the Modified Intent-to-Treat Population.
| Characteristic | Rivaroxaban Group (n = 95) |
Warfarin Sodium Group (n = 88) |
Total (n = 183) |
|---|---|---|---|
| Age, mean (SD), y | 70.2 (10.1) | 70.6 (10.9) | 70.4 (10.4) |
| Female sex, No. (%) | 40 (42.1) | 36 (40.9) | 76 (41.5) |
| Time from onset to randomization, median (IQR), d | 2.0 (2.0-3.0) | 2.0 (2.0-3.0) | 2.0 (2.0-3.0) |
| NIHSS score at randomization, median (IQR) | 2.0 (1.0-4.0) | 2.0 (0.0-4.0) | 2.0 (0.0-4.0) |
| Initial DWI volume, median (IQR),a cm3 | 2.6 (0.3-10.8) | 5.5 (1.1-14.5) | 3.5 (0.5-12.3) |
| Prestroke CHA2DS2-VASc scoreb | |||
| 0 | 11 (11.6) | 10 (11.4) | 21 (11.5) |
| 1 | 16 (16.8) | 15 (17.0) | 31 (16.9) |
| 2 | 14 (14.7) | 26 (29.5) | 40 (21.9) |
| 3 | 20 (21.1) | 17 (19.3) | 37 (20.2) |
| 4 | 22 (23.2) | 14 (15.9) | 36 (19.7) |
| 5 | 8 (8.4) | 6 (6.8) | 14 (7.7) |
| 6 | 3 (3.2) | 0 | 3 (1.6) |
| 7 | 1 (1.1) | 0 | 1 (0.5) |
| Mean (SD) | 2.7 (1.7) | 2.3 (1.4) | 2.5 (1.6) |
| Prestroke HAS-BLED scorec | |||
| 0 | 13 (13.7) | 15 (17.0) | 28 (15.3) |
| 1 | 46 (48.4) | 44 (50.0) | 90 (49.2) |
| 2 | 25 (26.3) | 25 (28.4) | 50 (27.3) |
| 3 | 9 (9.5) | 4 (4.5) | 13 (7.1) |
| 4 | 2 (2.1) | 0 | 2 (1.1) |
| Mean (SD) | 1.4 (0.9) | 1.2 (0.8) | 1.3 (0.9) |
| Paroxysmal atrial fibrillation, No. (%) | 25 (26.3) | 24 (27.3) | 49 (26.8) |
| Prior VKA use, No. (%)d | 39 (41.1) | 36 (40.9) | 75 (41.0) |
| Risk factor, No. (%) | |||
| Hypertension | 65 (68.4) | 52 (59.1) | 117 (63.9) |
| Diabetes mellituse | 24 (25.3) | 10 (11.4) | 34 (18.6) |
| Hyperlipidemia | 16 (16.8) | 18 (20.5) | 34 (18.6) |
| Coronary artery disease | 13 (13.7) | 12 (13.6) | 25 (13.7) |
| Baseline neuroimaging performed, No. (%) | |||
| CT | 67 (70.5) | 63 (71.6) | 130 (71.0) |
| MRI | 95 (100.0) | 88 (100.0) | 183 (100.0) |
| DWI | 95 (100.0) | 87 (98.9) | 182 (99.5) |
| FLAIR | 95 (100.0) | 87 (98.9) | 182 (99.5) |
| GRE | 87 (91.6) | 79 (89.8) | 166 (90.7) |
| SWI | 9 (9.5) | 9 (10.2) | 18 (9.8) |
| Other | 18 (18.9) | 20 (22.7) | 38 (20.8) |
| Blood pressure at study entry, mean (SD), mm Hg | |||
| Systolic | 131.8 (19.1) | 128.0 (17.0) | 130.0 (18.2) |
| Diastolic | 76.8 (11.7) | 77.4 (10.9) | 77.1 (11.3) |
| Heart rate, mean (SD), beats per minute | 84.5 (22.7) | 83.3 (23.3) | 83.9 (22.9) |
| Serum creatinine, mean (SD), mg/dL | 0.89 (0.24) | 0.89 (0.25) | 0.89 (0.24) |
| Concomitant antiplatelet agent use, No. (%) | 34 (35.8) | 23 (26.1) | 57 (31.1) |
| Single antiplatelet agent | 28 (29.5) | 20 (22.7) | 48 (26.2) |
| Aspirin | 25 (26.3) | 11 (12.5) | 36 (19.7) |
| Clopidogrel bisulfate | 2 (2.1) | 7 (8.0) | 9 (4.9) |
| Other | 1 (1.1) | 2 (2.3) | 3 (1.6) |
| Dual antiplatelet agents | 6 (6.3) | 3 (3.4) | 9 (4.9) |
Abbreviations: CHA2DS2-VASc, congestive heart failure, hypertension, age ≥75 years (doubled), diabetes, stroke (doubled), vascular disease, age 65-74 years, sex category (female); CT, computed tomography; DWI, diffusion-weighted imaging; FLAIR, fluid-attenuated inversion recovery; GRE, gradient-recalled echo; HAS-BLED, hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly; IQR, interquartile range; MRI, magnetic resonance imaging; NIHSS, National Institutes of Health Stroke Scale; SWI, susceptibility-weighted imaging; VKA, vitamin K antagonist.
SI conversion factor: To convert creatinine to micromoles per liter, multiply by 88.4.
P = .04.
The CHA2DS2-VASc scores range from 0 to 9, with higher scores indicating a greater risk of stroke: congestive heart failure, hypertension, diabetes, 65 to 74 years of age, female sex, and vascular disease are each assigned 1 point, and prior stroke or transient ischemic attack and being 75 years of age or older are assigned 2 points.
The HAS-BLED scores range from 0 to 9, with higher scores indicating a greater bleeding risk: hypertension, abnormal renal function, abnormal liver function, prior stroke history, bleeding, labile international normalized ratios, elderly (>65 years of age), prior alcohol or drug use, and medication use predisposing to bleeding are each assigned 1 point.
Use of VKA within 30 days before randomization.
P = .02.