Table 2. Primary and Secondary Efficacy Outcomes and Safety Outcomes.
| Characteristic | No./No. (%) | Unadjusted Outcome Variable Value (95% CI) | P Value | Adjusted Value (95% CI)a | P Value | Propensity Score Matching | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All | Control | EVT | No./Total No. (%) | χ2/z Value | P Value | |||||||
| All | Control | EVT | ||||||||||
| Primary efficacy outcome | ||||||||||||
| Modified Rankin Scale score at 90 d, median (IQR) | 6 (3-6) | 6 (5-6) | 5 (2-6) | 3.09 (2.17-4.39)b | <.001 | 3.08 (2.09-4.55) | <.001 | 6 (4-6) | 6 (5-6) | 5 (2-6) | z = −4.513 | <.001 |
| Secondary efficacy outcomes | ||||||||||||
| Modified Rankin Scale score at 90 d | ||||||||||||
| 0-3 | 224/829 (27.0) | 17/182 (9.3) | 207/647 (32.0) | 4.57 (2.70-7.73)c | <.001 | 4.70 (2.53-8.75) | <.001 | 64/334 (19.2) | 17/167 (10.2) | 47/167 (28.1) | χ21 = 17.396 | <.001 |
| 0-2 | 190/829 (22.9) | 13/182 (7.1) | 177/647 (27.4) | 4.90 (2.71-8.83)c | <.001 | 4.90 (2.43-9.87) | <.001 | 56/334 (16.8) | 13/167 (7.8) | 43/167 (25.7) | χ21 = 19.309 | <.001 |
| 0-1 | 144/829 (17.4) | 10/182 (5.5) | 134/647 (20.7) | 4.49 (2.31-8.74)c | <.001 | 4.54 (2.16-9.56) | <.001 | 44/334 (13.2) | 10/167 (6.0) | 34/167 (20.4) | χ21 = 15.077 | <.001 |
| NIHSS score, median (IQR) | ||||||||||||
| Change from baseline at 24 he | 0 (−2 to 3) | 0 (0-6) | 0 (−4 to 3) | −4.16 (−5.77 to −2.55)d | <.001 | −3.35 (−4.98 to −1.71) | <.001 | 0 (0-4) | 0 (0-5) | 0 (−3 to 4) | z = −1.794 | .07 |
| Change from baseline at 5-7 df | 0 (−9 to 4) | 1 (0-9.5) | −2 (−12 to 3) | −7.20 (−9.25 to −5.16)d | <.001 | −6.28 (−8.33 to −4.21) | <.001 | 0 (−5 to 6) | 1 (0-10) | 0 (−8 to 4) | z = −4.077 | <.001 |
| mTICI score of 2b or 3 at final angiogram | 533/829 (64.3) | 11/182 (6.0) | 522/647 (80.7) | NA | NA | NA | NA | 143/334 (42.8) | 11/167 (6.6) | 132/167 (79.0) | χ21 = 179.039 | <.001 |
| Safety outcomes | ||||||||||||
| Mortality at 90 d | 429/829 (51.7) | 130/182 (71.4) | 299/647 (46.2) | 2.91 (2.04-4.16)c | <.001 | 2.93 (1.95-4.40) | <.001 | 196/334 (58.7) | 117/167 (70.1) | 79/167 (47.3) | χ21 = 17.831 | <.001 |
| Intracranial hemorrhage | <.001 | NA | ||||||||||
| Symptomatic | 46/818 (5.6) | 1/182 (0.5) | 45/636 (7.1) | NA | NA | 13/331 (3.9) | 1/167 (0.6) | 12/164 (7.3) | χ22 = 19.029 | <.001 | ||
| Asymptomatic | 17/818 (2.1) | 0 | 17/636 (2.7) | NA | NA | 5/331 (1.5) | 0 | 5/164 (3.0) | ||||
Abbreviations: EVT, endovascular treatment; mTICI, Modified Treatment in Cerebral Infarction; NA, not applicable; NIHSS, National Institutes of Health Stroke Scale.
Adjusted estimates of outcome were calculated using multiple regression, taking the following variables into account: age, baseline NIHSS score, baseline pc-ASPECTS, onset-to-imaging diagnosis time, sex, intravenous thrombolysis, diabetes mellitus, ischemic stroke, onset-to–outcome measurement time, and location of occlusion.
Common odds ratio; the primary analysis involved 647 patients in the endovascular treatment group and 182 patients in the control group. Scores on the mRS of functional disability range from 0 (no symptoms) to 6 (death). The common odds ratio was estimated from an ordinal logistic regression model and indicates the odds of improvement of 1 point on the mRS, with a common odds ratio greater than 1 favoring the endovascular treatment.
The odds ratios were estimated from a binary logistic regression model.
The β values were estimated from a multivariable linear regression model.
The NIHSS score was determined for survivors only. The score was not available for 7 patients; 4 died before assessment was finished, and 3 had missing scores. In the propensity score matching data set, the score was not available for 1 patient who died before assessment was finished.
The NIHSS score was determined for survivors only. The score was not available for 40 patients; 37 died before assessment was finished, and 3 had missing scores. In the propensity score matching data set, the score was not available for 16 patients because they died before assessment was finished.