Medical management (n=21) | Thrombectomy procedure (n=12) | Odds ratio (95% CI) | P value | |
Asymptomatic ICH up to 24 hours post-randomization | 9.5 (2/21) | 33 (4/12) | 0.21 (0.03 to 1.39) | 0.16 |
Symptomatic ICH up to 24 hours post-randomization | 0 (0/21) | 0 (0/12) | NA | NA |
ICH within 90 days of hospital discharge (excluding discharge) | 0 (0/21) | 0 (0/12) | NA | NA |
ICH within 90 days of hospital discharge (including discharge) | 14 (3/21) | 17 (2/12) | 0.83 (0.12 to 5.85) | 1.00 |
Clinically significant complications at time of discharge or 7 days post randomization, whichever comes first | ||||
Arrhythmia | 0 (0/21) | 8.3 (1/12) | NA | 0.36 |
Neurological deterioration | 19 (4/21) | 0 (0/12) | NA | 0.27 |
Pneumonia | 4.8 (1/21) | 0 (0/12) | NA | 1.00 |
Respiratory failure | 4.8 (1/21) | 0 (0/12) | NA | 1.00 |
Worsening of pre-existing condition | 4.8 (1/21) | 8.3 (1/12) | 0.55 (0.03 to 9.68) | 1.00 |
SAEs related to thrombectomy procedure up to 48 hours | 0.0 (0/1)* | 8.3 (1/12) | NA | 0.36 |
SAEs related to thrombectomy device up to 48 hours | 0.0 (0/1)* | 0.0 (0/12) | NA | NA |
SAEs related to index stroke up to 48 hours | 19 (4/21) | 8.3 (1/12) | 2.59 (0.25 to 26.3) | 0.63 |
SAEs related to medical management up to 48 hours | 0.0 (0/21) | 0.0 (0/12) | NA | NA |
*One patient assigned to the medical management group received thrombectomy.
ICH, intracranial hemorrhage; SAE, serious adverse event.