Table 2. Primary and Secondary Efficacy Outcomes.
| Outcomes | No./Total (%)a | Risk Difference, % (95% CI)b |
Odds Ratio (95% CI) |
P Value | |
|---|---|---|---|---|---|
| First-Line Contact Aspiration (n = 192) |
First-Line Stent Retriever (n = 189) |
||||
| Primary Efficacy Outcome | |||||
| Successful revascularization at the end of all procedures | |||||
| mTICI score of 2b or 3 assessed by core laboratoryc,d | |||||
| Intention-to-treat analysise | 164/192 (85.4) | 157/189 (83.1) | 2.4 (−5.4 to 9.7) | 1.20 (0.68-2.10) | .53 |
| Per-protocol analysis | 140/153 (91.5) | 140/165 (84.9) | 6.8 (−0.6 to 14.11) | 1.91 (0.93-3.91) | .08 |
| mTICI score of 2b or 3 assessed at study sited,f | 163/192 (84.9) | 163/189 (86.2) | −1.4 (−8.3 to 5.5) | 0.90 (0.50-1.59) | .71 |
| Secondary Angiographic Efficacy Outcomes | |||||
| Complete revascularization at the end of all procedures | |||||
| mTICI score of 3 assessed by core laboratoryd | 72/192 (37.5) | 73/189 (38.6) | −1.1 (−11.0 to 9.0) | 0.95 (0.62-1.45) | .82 |
| mTICI score of 2c or 3 assessed by core laboratoryd | 108/192 (56.3) | 107/189 (56.6) | 0.4 (−10.9 to 9.7) | 0.99 (0.65-1.48) | .84 |
| Successful revascularization after first-line strategy alone | |||||
| mTICI score of 2b or 3 assessed by core laboratoryd | 121/192 (63.0) | 128/189 (67.7) | −4.7 (−13.8 to 4.4) | 0.81 (0.53-1.24) | .34 |
| mTICI score of 3 assessed by core laboratoryd | 55/192 (28.7) | 67/189 (35.5) | −6.8 (−16.2 to 2.5) | 0.73 (0.54-1.13) | .16 |
| mTICI score of 2c or 3 assessed by core laboratoryd | 83/192 (43.2) | 94/189 (49.7) | −6.5 (−16.4 to 3.3) | 0.77 (0.51-1.16) | .21 |
| Use of rescue treatment | 63/192 (32.8) | 45/189 (23.8) | 9.0 (−0.9 to 18.1) | 1.57 (0.99-2.47) | .05 |
| Clinical Efficacy Outcomes | |||||
| Change in NIHSS score at 24 h, mean (95% CI)g |
−4.8 (−6.1 to −3.6)h | −5.2 (−6.5 to −3.9)h | 0.38 (−1.42 to 2.18)i | NA | .68 |
| Functional independence at 3 moj | 82/181 (45.3) | 91/182 (50.0) | −4.6 (−14.7 to 6.1) | 0.83 (0.54-1.26) | .38 |
| Modified Rankin Scale score at 3 mo, median (interquartile range) | 3.0 (1.0 to 5.0) | 2.5 (1.0 to 5.0) | NA | 0.76 (0.53-1.10)k | .15 |
Abbreviations: mTICI, modified Treatment in Cerebral Infarction; NA, not applicable; NIHSS, National Institutes of Health Stroke Scale.
Values expressed as No./total No. (%) unless otherwise indicated. Effect sizes were calculated after adjustment for randomization stratification variables (center and intravenous thrombolysis).
Expressed as a percentage and calculated from the marginal probabilities accordingly to the Austin method unless otherwise indicated.
Eleven patients in the contact aspiration group and 13 in the stent retriever group were not assessed by the core laboratory because of groin access failure or unavailable or poor-quality images.
mTICI score: 0, no perfusion or anterograde flow beyond site of occlusion; 1, penetration but not perfusion (contrast penetration exists past the initial obstruction but with minimal filling of the normal territory); 2, incomplete perfusion wherein the contrast passes the occlusion and opacifies the distal arterial bed but rate of entry or clearance from the bed is slower or incomplete compared with noninvolved territories; 2a, some perfusion with distal branch filling of <50% of territory visualized; 2b, substantial perfusion with distal branch filling of ≥50% of territory visualized; 2c, near-complete perfusion except for slow flow in a few distal cortical vessels or presence of small distal cortical emboli; and 3, complete perfusion with normal filling of all distal branches.
Prespecified as the primary efficacy analysis.
Unplanned sensitivity analysis.
There were 23 missing 24-hour NIHSS values (12 in the contact aspiration group).
Mean change (95% CI) adjusted on baseline NIHSS score.
Mean risk difference adjusted on baseline NIHSS score.
Defined as a modified Rankin Scale score ≤2.
Common odds ratio of improvement of 1 point in modified Rankin Scale score.