Table 2.
Primary and secondary outcomes in the modified intention-to-treat analysis set
| Outcome | ED Group (n = 97) | Control Group (n = 103) | Treatment Effect Metric | Unadjusted | Adjusteda | ||
|---|---|---|---|---|---|---|---|
| Treatment Difference (95% CI) | P Value | Treatment Difference (95% CI) | P Value | ||||
| Primary outcome | |||||||
| mRS score 0–2 at 90 ± 7 days, No. (%)b | 54/92 (58.7) | 49/94 (52.1) | OR | 1.37 (0.76–2.44) | 0.29 | 1.36 (0.71–2.58) | 0.35 |
| Secondary outcomes | |||||||
| mRS score 0−1 at 90 ± 7 days, No. (%)b | 41/92 (44.6) | 38/94 (40.4) | OR | 1.19 (0.66–2.12) | 0.57 | 1.11 (0.59–2.09) | 0.74 |
| mRS score distribution at 90 ± 7 daysb | OR c | 0.74 (0.44−1.22) | 0.24 | 0.79 (0.47–1.34) | 0.38 | ||
| Change in NIHSS score from baseline, GM (GMSD)d | |||||||
| at 24 h | 0.651 (1.85) | 0.709 (1.81) | GMRe | −0.02 (−0.11 to 0.08) | 0.70 | 0.00 (−0.09 to 0.09) | 0.97 |
| at 48 h | 0.508 (2.05) | 0.598 (1.89) | GMRe | −0.07 (−0.16 to 0.01) | 0.09 | −0.06 (−0.14 to 0.03) | 0.20 |
| at 12 ± 2 days | 0.297 (2.56) | 0.384 (2.24) | GMRe | −0.11 (−0.23 to 0.00) | 0.06 | -0.09 (−0.20 to 0.03) | 0.14 |
| Infarct volume at 1 week, GM (GMSD)f | 1.170 (2.00) | 1.291 (1.58) | GMRe | 0.12 (−0.07 to 0.31) | 0.22 | 0.09 (−0.09 to 0.26) | 0.34 |
| All-cause mortality within 90 ± 7 days, No. (%) | 14 (14.4) | 17 (16.5) | HRg | 0.84 (0.41−1.70) | 0.62 | 0.95 (0.45−1.99) | 0.89 |
ED edaravone dexborneol, CI confidence interval, mRS modified Rankin Scale, OR odds ratio, NIHSS National Institutes of Health Stroke Scale, GM geometric mean, GMSD geometric mean standard deviation, GMR geometric mean ratio, HR hazard ratio.
aAdjusted for key prognostic covariates (age, sex, pre-stroke score on the modified Rankin Scale, NIHSS score at baseline, previous ischemic stroke, time from onset to recanalization, cerebral collateral circulation grade, number of thrombectomy device passes, and Intravenous thrombolysis).
bmRS scores range from 0 to 6: 0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death. Data missing for 14 participants for mRS score at 90 ± 7 days.
cCalculated with ordinal regression analysis.
dNIHSS scores range 0–42, with higher scores indicating greater stroke severity. The log (NIHSS + 1) was analyzed using a geometric mean ratio by generalized linear model. Data missing for 10 participants for NIHSS score at 24 h, 23 participants at 48 h, and 34 participants at 12 ± 2 days.
eGMR was used because normality assumption was assessed graphically and residual histogram showed serious violation of normality assumption.
fDetermined by brain CT or MRI. The log (Infarct volume +1) was analyzed using a geometric mean by generalized linear model. Data missing for 11 participants for infarct volume at 1 week. Data eliminating for 1 participant due to excessive deviation.
gCalculated with Cox regression model.