Table 2. End Points in the Modified Intent-to-Treat Population.
| End Point | Rivaroxaban Group, No. (%) (n = 95) |
Warfarin Sodium Group, No. (%) (n = 88) |
Risk Difference (95% CI) |
Relative Risk (95% CI) |
P Value | Adjusted Relative Risk (95% CI)a |
P Value |
|---|---|---|---|---|---|---|---|
| Intracranial hemorrhage or recurrent ischemic lesion on results of 4-wk MRI (primary end point) | 47 (49.5) | 48 (54.5) | –5.07 (–19.52 to 9.49) |
0.91 (0.69 to 1.20) |
.49 | 0.97 (0.79 to 1.18) |
.73 |
| Recurrent ischemic lesion on results of 4-wk MRIb | 28 (29.5) | 31 (35.6) | –6.16 (–20.48 to 8.45) |
0.83 (0.54 to 1.26) |
.38 | 0.85 (0.56 to 1.30) |
.45 |
| Intracranial hemorrhage on results of 4-wk MRIb | 30 (31.6) | 25 (28.7) | 2.84 (–11.68 to 17.29) |
1.10 (0.70 to 1.71) |
.68 | 1.17 (0.74 to 1.85) |
.50 |
| Clinical recurrent ischemic stroke | 1 (1.1) | 1 (1.1) | –0.08 (–14.54 to 14.42) |
0.93 (0.06 to 14.59) |
>.99 | NA | NA |
| Symptomatic hemorrhagic conversion or hemorrhagic stroke | 0 | 0 | NA | NA | >.99 | NA | NA |
| Major bleeding | 1 (1.1) | 0 | 1.05 (–13.44 to 15.53) |
NA | >.99 | NA | NA |
| Systemic embolism | 0 | 0 | NA | NA | >.99 | NA | NA |
| Acute coronary syndrome | 0 | 0 | NA | NA | >.99 | NA | NA |
| Composite of stroke, MI, or vascular death | 1 (1.1) | 1 (1.1) | –0.08 (–14.54 to 14.42) |
0.93 (0.06 to 14.59) |
>.99 | NA | NA |
| Composite of stroke, MI, vascular death, or major bleeding | 2 (2.1) | 1 (1.1) | 0.97 (–13.50 to 15.46) |
1.85 (0.17 to 20.08) |
>.99 | NA | NA |
| Composite of clinical ischemic events | 1 (1.1) | 1 (1.1) | –0.08 (–14.54 to 14.42) |
0.93 (0.06 to 14.59) |
>.99 | NA | NA |
| Duration of hospitalization, median (IQR), d | 4.0 (2.0-6.0) | 6.0 (4.0-8.0) | NA | NA | <.001 | NA | .002 |
| mRS score 0–1 at 4 wkc | 79 (84.0) | 64 (74.4) | 9.62 (–5.06 to 23.95) |
1.13 (0.97 to 1.31) |
.11 | 1.04 (0.83 to 1.29) |
.73 |
Abbreviations: IQR, interquartile range; MI, myocardial infarction; MRI, magnetic resonance imaging; mRS, modified Rankin Scale; NA, not applicable.
Adjusted for age, sex, initial ischemic lesion volume on diffusion-weighted imaging, diabetes, prior use of vitamin K antagonist, concomitant use of antiplatelet agent, and center.
Of the patients in the warfarin group who were included in the intent-to-treat population and were evaluated for the primary end point, recurrent ischemic lesion on results of 4-week MRI was not evaluated in 1 patient, and new intracranial hemorrhage on 4-week MRI was not evaluated in 1 patient (detailed description in eTable 4 in Supplement 2). Sensitivity analyses assuming worst-case and best-case scenarios for these patients are provided in eTable 4 in Supplement 2.
Of the intent-to-treat population, the mRS score at 4 weeks was not available in 1 patient in the rivaroxaban group and in 2 patients in the warfarin group.