Table 3.
Safety Outcomes in the Safety Population
| Outcome | ED Group (n = 97)a | Control Group (n = 103)a | Treatment Effect Metric | Unadjusted | Adjustedb | ||
|---|---|---|---|---|---|---|---|
| Treatment Difference (95% CI) | P Value | Treatment Difference (95% CI) | P Value | ||||
| sICH at 48 h, No. (%)c | 5/94 (5.3) | 11/101 (10.9) | OR | 0.46 (0.15–1.37) | 0.17 | 0.39 (0.11 to 1.35) | 0.14 |
| Intracerebral hemorrhage at 48 h, No. (%)c | |||||||
| PH−1 | 3/94 (3.2) | 11/101 (10.9) | OR | 0.27 (0.07−1.00) | 0.05 | 0.21 (0.05–0.89) | 0.03 |
| PH-2 | 5/94 (5.3) | 4/101 (4.0) | OR | 1.36 (0.36–5.23) | 0.65 | 1.08 (0.25–4.73) | 0.92 |
| HI−1 | 3/94 (3.2) | 1/101 (1.0) | OR | 3.30 (0.34–32.26) | 0.31 | 4.01 (0.21–76.58) | 0.36 |
| HI-2 | 4/94 (4.3) | 13/101 (12.9) | OR | 0.30 (0.09–0.96) | 0.04 | 0.27 (0.08–0.95) | 0.04 |
| SAE within 90 days, No. (%)d | 21 (21.6) | 30 (29.1) | HRe | 0.75 (0.43−1.30) | 0.30 | 0.90 (0.50−1.60) | 0.72 |
sICH symptomatic intracranial hemorrhage, PH parenchymal hemorrhage, HI hemorrhagic infarct, SAE serious adverse events.
aFive patients lacked safety outcomes due to discharging within 48 h after receiving the treatment (3 in ED group and 2 in Control group).
bAdjusted 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).
cDefined according to European Cooperative Acute Stroke Study (ECASS).
dSAE included parenchymal hemorrhage, subarachnoid hemorrhage, cerebral hernia, respiratory failure, acute ischemic stroke, cerebral edema, sudden cardiac death, gastrointestinal hemorrhage, liver dysfunction, etc. Two patients occurred SAE presented with liver dysfunction possibly related to ED.
eCalculated with Cox regression model.