Table 2. Primary Outcomes, Secondary Outcomes, and Adverse Events.
| ITT analysis | PP analysis | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| No. (%) | OR (95% CI) | No. (%) | OR (95% CI) | |||||||
| GA (n = 43) | CS (n = 44) | Unadjusted | P value | Adjusteda | GA (n = 43) | CS (n = 31) | Unadjusted | P value | Adjusteda | |
| mRS score 0-2 at 90 d | 21 (48.8) | 24 (54.5) | 0.80 (0.34-1.85) | NA | 0.91 (0.37-2.22) | 21 (48.8) | 19 (61.3) | 0.60 (0.24-1.54) | NA | 0.64 (0.23-1.80) |
| mRS score at 90 d | ||||||||||
| Excellent outcome (mRS 0-1) | 10 (23.3) | 17 (38.6) | 0.48 (0.19-1.22) | NA | 0.58 (0.22-1.53) | 10 (23.3) | 14 (45.2) | 0.37 (0.14-1.00) | NA | 0.43 (0.15-1.27) |
| Poor outcome (mRS ≥3) | 22 (51.2) | 20 (45.5) | 1.26 (0.54-2.92) | NA | 1.10 (.45-2.69) | 22 (51.2) | 12 (38.7) | 1.66 (0.65-4.24) | NA | 1.56 (0.55-4.38) |
| Successful reperfusion (mTICI 2b-3) | 41 (95.3) | 34 (77.3) | 6.03 (1.24-29.40) | NA | 5.86 (1.16-29.53) | 41 (95.3) | 24 (77.4) | 5.98 (1.15-31.14) | NA | 5.12 (0.94-27.84) |
| NIHSS score, median (IQR)b | ||||||||||
| At discharge | 5 (3-12) | 8 (2-16) | NA | .68 | NA | 5 (3-12) | 8 (2-16) | NA | .86 | NA |
| 30 d After therapy | 2 (1-6) | 2 (0-9) | NA | .60 | NA | 2 (1-6) | 2 (0-7) | NA | .45 | NA |
| 90 d After therapy | 1 (1-3) | 0 (0-5) | NA | .23 | NA | 1 (1-3) | 0 (0-2) | NA | .14 | NA |
| GCS, median (IQR)c | ||||||||||
| At discharge | 15 (12-15) | 15 (10-15) | NA | .95 | NA | 15 (12-15) | 15 (12-15) | NA | .76 | NA |
| 30 d After therapy | 15 (14-15) | 15 (13-15) | NA | .94 | NA | 15 (14-15) | 15 (14-15) | NA | .99 | NA |
| 90 d After therapy | 15 (15-15) | 15 (15-15) | NA | .48 | NA | 15 (15-15) | 15 (15-15) | NA | .50 | NA |
| Assisted ventilation | 31 (72.1) | 18 (40.9) | 0.27 (0.11-0.66) | NA | 0.26 (0.10-0.69) | 31 (72.1) | 5 (16.1) | 0.74 (0.02-0.24) | NA | 0.06 (0.02-0.23) |
| Length of assisted ventilation, median (IQR), d | 4 (2-7) | 7 (3-13) | NA | .23 | NA | 4 (2-7) | 7 (2-16) | NA | .53 | NA |
| Length of stay in hospital, median (IQR), d | 9 (6-17) | 11 (6-15) | NA | .87 | NA | 9 (6-17) | 12 (6-15) | NA | .73 | NA |
| Length of stay in the neurological intensive care unit, median (IQR), d | 8 (5-15) | 9 (4-15) | NA | .77 | NA | 8 (5-15) | 9 (4-14) | NA | .70 | NA |
| Mortality | ||||||||||
| At discharge | 5 (11.6) | 4 (9.1) | 1.32 (0.33-5.27) | NA | 1.36 (0.33-5.67) | 5 (11.6) | 1 (3.2) | 3.95 (0.44-35.62) | NA | 4.63 (0.49-43.61) |
| At 30 d | 9 (22.0) | 9 (21.4) | 1.03 (0.36-2.93) | NA | 1.05 (0.35-3.14) | 9 (22.0) | 5 (17.2) | 1.35 (0.40-4.55) | NA | 1.56 (0.42-5.80) |
| At 90 d | 10 (23.3) | 9 (20.5) | 1.18 (0.43-3.26) | NA | 1.18 (0.41-3.41) | 10 (23.3) | 5 (16.1) | 1.58 (0.48-5.18) | NA | 1.81 (0.51-6.44) |
| Adverse events during treatment | ||||||||||
| Hypotensiond | 23 (53.5) | 7 (15.9) | 0.17 (0.06-0.45) | NA | 0.17 (0.06-0.47) | 23 (53.5) | 3 (9.7) | 0.09 (0.03-0.35) | NA | 0.10 (0.03-0.40) |
| Dysphoria or motion | 1 (2.3) | 16 (36.4) | 24.00 (2.01-191.36) | NA | 26.10 (3.14-215.94) | 1 (2.3) | 5 (16.1) | 8.08 (0.89-73.04) | NA | 7.22 (0.73-70.95) |
| Complications after EVT | ||||||||||
| Pulmonary infection | 28 (65.1) | 20 (45.5) | 0.45 (0.19-1.06) | NA | 0.51 (0.21-1.25) | 28 (65.1) | 12 (38.7) | 0.34 (0.13-0.88) | NA | 0.44 (0.16-1.22) |
| Deep venous thrombosis | 3 (7.0) | 3 (6.8) | 0.98 (0.19-5.12) | NA | 1.06 (0.19-5.90) | 3 (7.0) | 2 (6.5) | 0.92 (0.14-5.86) | NA | 1.11 (0.16-7.72) |
| Hemorrhagic transformatione | 3 (7.0) | 2 (4.5) | 0.64 (0.10-4.00) | NA | 0.42 (0.05-3.48) | 3 (7.0) | 1 (3.2) | 0.44 (0.04-4.49) | NA | 0.35 (0.02-6.29) |
Abbreviations: CS, conscious sedation; EVT, endovascular therapy; GA, general anesthesia; GCS, Glasgow Coma Scale; ITT, intention-to-treat; mTICI, modified treatment in cerebral infarction; mRS, modified Rankin Scale; NA, not applicable; NIHSS, National Institute of Health Stroke Scale; OR, odds ratio; PP, per-protocol.
Adjusted odds ratios were estimated using a logistic regression model including age, baseline NIHSS score, occlusion site, and use of IV-tPA.
Missing data due to death or dropout. In ITT, data were missing for 4 patients in GA and 4 in CS at discharge, 9 in each group at 30 d, and 10 in GA and 9 in CS at 90 d. In PP, data were missing for 4 patients in GA and 1 in CS at discharge, 9 in GA and 5 in CS at 30 d, and 10 in GA and 5 in CS at 90 d.
Missing data due to death or dropout. In ITT, data were missing for 4 patients in GA and 4 in CS at discharge, 9 in each group at 30 d, and 10 in GA and 8 in CS at 90 d. In PP, data were missing for 4 patients in GA and 1 in CS at discharge, 9 in GA and 5 in CS at 30 d, and 10 in GA and 4 in CS at 90 d.
Defined as systolic blood pressure <120 mm Hg.
Includes symptomatic intracranial hemorrhage, defined as an increase in NIHSS score of >4 points within the first 36 h of stroke onset, and asymptomatic intracranial hemorrhage, defined as an increase in NIHSS score by ≤4 points within the first 36 h of stroke onset.