Table 2. Primary and Secondary Outcomes.
| Outcomes | Intensive management (n = 155) | Conventional management (n = 150) | Risk difference, % (95% CI) | Odds ratio (95% CI) | P value | |
|---|---|---|---|---|---|---|
| Unadjusted | Adjusteda | |||||
| Primary efficacy outcome | ||||||
| Functional independence at 3 mo (mRS score 0-2), No./total (%) | 61/155 (39.4) | 80/147 (54.4) | −15.1 (−26.2 to −3.9) | 0.54 (0.34 to 0.86) | 0.56 (0.33 to 0.96) | .03 |
| Primary safety outcomes | ||||||
| Symptomatic intracerebral hemorrhage, No./total (%) | 14/155 (9.0) | 12/149 (8.1) | 1.0 (−5.3 to 7.3) | 1.13 (0.51 to 2.54) | 1.10 (0.48 to 2.53) | .82 |
| Death related to index stroke within 3 mo, No./total (%) | 12/155 (7.7) | 8/147 (5.4) | 2.3 (−3.3 to 7.9) | 1.46 (0.58 to 3.68) | 1.73 (0.61 to 4.92) | .31 |
| Secondary outcomes | ||||||
| mRS score reduction (shift analysis) | 0.59 (0.40 to 0.88) | 0.65 (0.43 to 0.97) | .04 | |||
| NIHSS score at 24 h, mean (SD) | 11.56 (7.48) | 9.59 (7.45) | 1.97 (0.27 to 3.66) | 1.05 (−0.20 to 2.30)b | .10 | |
| Excellent recovery in NIHSS score at 24 h, No./total (%)c | 25/153 (16.3) | 37/148 (25.0) | −8.7 (−17.8 to 0.5) | 0.59 (0.33 to 1.03) | 0.62 (0.34 to 1.11) | .11 |
| Successful reperfusion at 24 h, No./total (%)d | 132/146 (90.4) | 132/141 (93.6) | −3.2 (−9.5 to 3.1) | 0.64 (0.27 to 1.54) | 0.66 (0.26 to 1.65) | .37 |
| Functional independence at 1 mo (mRS score 0-2), No./total (%) | 56/150 (37.3) | 72/144 (50.0) | −12.7 (−23.9 to −1.4) | 0.60 (0.37 to 0.95) | 0.65 (0.38 to 1.11) | .12 |
| EQ-5D-3L score, mean (SD) | 0.50 (0.43) | 0.61 (0.40) | −0.12 (−0.21 to −0.02) | −0.08 (−0.16 to −0.01)b | .05 | |
| Malignant cerebral edema, No./total (%)e | 12/155 (7.7) | 2/149 (1.3) | 6.4 (1.8-11.0) | 6.17 (1.36 to 28.05) | 7.88 (1.57 to 39.39) | .01 |
Abbreviations: EQ-5D-3L, 3-level EuroQoL 5-Dimension Self-Report Questionnaire; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale.
Adjusted for age, sex, onset to randomization time, and NIHSS score immediately prior to endovascular thrombectomy.
Analyzed with linear regression adjusted for age, sex, onset to randomization time, and NIHSS score immediately prior to endovascular thrombectomy.
Indicated by an NIHSS score of 0 to 1 or improvement of more than 8 points.
Successful reperfusion at 24 hours was defined as a modified Thrombolysis in Cerebral Infarction score of 2b or greater by magnetic resonance angiography or computed tomography angiography at 24 hours.
Malignant cerebral edema is a condition characterized by rapid neurological deterioration accompanied by substantial brain swelling seen on computed tomography or magnetic resonance imaging, which often leads to death or poor functional outcomes.