Efficacy outcomes
| Medical management (n=21) | Thrombectomy procedure (n=12) | Odds ratio (95% CI) | P value | |
| Primary endpoint | ||||
| Cochran–Mantel–Haenszel statistic | ||||
| mRS (5–6 collapsed) | NA | NA | 0.0349 | |
| 0 | 4.8 (1/21) | 33 (4/12) | ||
| 1 | 14 (3/21) | 33 (4/12) | ||
| 2 | 24 (5/21) | 8.3 (1/12) | ||
| 3 | 14 (3/21) | 0 (0/12) | ||
| 4 | 9.5 (2/21) | 8.3 (1/12) | ||
| 5–6 | 33 (7/21) | 17 (2/12) | ||
| Secondary outcomes | ||||
| Proportion of patients achieving mRS 0–2 | 42.9 (9/21) | 75.0 (9/12) | 0.25 (0.05 to 1.20) | 0.15 |
| Proportion of patients achieving mRS 3–6 | 57.1 (12/21) | 25.0 (3/12) | 4.00 (0.84 to 19.2) | 0.15 |
| 90-day global disability in the 6–12 hour cohort assessed via the overall distribution of mRS | NA | NA | 0.21 | |
| 0 | 12.5 (1/8) | 25 (1/4) | ||
| 1 | 0 (0/8) | 25 (1/4) | ||
| 2 | 25 (2/8) | 0 (0/4) | ||
| 3 | 12.5 (1/8) | 0 (0/4) | ||
| 4 | 25 (2/8) | 0 (0/4) | ||
| 5 | 0 (0/8) | 25 (1/4) | ||
| 6 | 25 (2/8) | 25 (1/4) | ||
| Proportion of patients achieving mRS 0–2 for 6–12 hour cohort | 37.5 (3/8) | 50 (2/4) | 0.6 (0.05 to 6.8) | 1.00 |
| Proportion of patients achieving mRS 3–6 for 6–12 hour cohort | 62.5 (5/8) | 50 (2/4) | 1.7 (0.15 to 18.9) | 1.00 |
| Mortality at 30 and 90 days | ||||
| Mortality at 30 days | 12 (2/17)* | 0.0 (0/12) | NA | 0.50 |
| Mortality at 90 days | 19.1 (4/21) | 8.3 (1/12) | 2.6 (0.25 to 26.31) | 0.63 |
| ICH with neurological deterioration (NIHSS worsening ≥4) within 24 hours of randomization | 0.0 (0/21) | 0.0 (0/12) | NA | NA |
| ICH with neurological deterioration (NIHSS worsening ≥4) | 0.0 (0/20)§ | 0.0 (0/12) | NA | NA |
| SAEs related to thrombectomy procedure | 0.0 (0/21) | 8.3 (1/12) | NA | 0.36 |
| SAEs related to thrombectomy device | 0.0 (0/21) | 0.0 (0/12) | NA | NA |
| SAEs related to index stroke | 33 (7/21) | 8.3 (1/12) | 5.5 (0.6 to 51.6) | 0.21 |
| SAEs related to medical management | 4.8 (1/21) | 0.0 (0/12) | NA | 1.00 |
| Arterial revascularization measured by mTICI 2b or 3 following intervention | 100 (1/1) † | 83 (10/12) ‡ | NA | NA |
*One patient had no NIHSS scores after baseline and was excluded from this analysis.
†One patient assigned to the medical management group received anesthesia with the intent for thrombectomy although this was not required due to clot dissolution.
‡One patient’s mTICI score was self-reported due to insufficient imaging for the core laboratory to assess.
§4 30-* Four 30-day mRS values are missing.
ICH, intracranial hemorrhage; mRS, modified Rankin Scale; mTICI, modified Thrombolysis in Cerebral Infarction; NIHSS, National Institutes of Health Stroke Scale.