Table 1

Safety outcomes

Medical management
(n=21)
Thrombectomy procedure
(n=12)
Odds ratio (95% CI)P value
Asymptomatic ICH up to 24 hours post-randomization9.5 (2/21)33 (4/12)0.21 (0.03 to 1.39)0.16
Symptomatic ICH up to 24 hours post-randomization0 (0/21)0 (0/12)NANA
ICH within 90 days of hospital discharge (excluding discharge)0 (0/21)0 (0/12)NANA
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
 Arrhythmia0 (0/21)8.3 (1/12)NA0.36
 Neurological deterioration19 (4/21)0 (0/12)NA0.27
 Pneumonia4.8 (1/21)0 (0/12)NA1.00
 Respiratory failure4.8 (1/21)0 (0/12)NA1.00
 Worsening of pre-existing condition4.8 (1/21)8.3 (1/12)0.55 (0.03 to 9.68)1.00
SAEs related to thrombectomy procedure up to 48 hours0.0 (0/1)*8.3 (1/12)NA0.36
SAEs related to thrombectomy device up to 48 hours0.0 (0/1)*0.0 (0/12)NANA
SAEs related to index stroke up to 48 hours19 (4/21)8.3 (1/12)2.59 (0.25 to 26.3)0.63
SAEs related to medical management up to 48 hours0.0 (0/21)0.0 (0/12)NANA
  • *One patient assigned to the medical management group received thrombectomy.

  • ICH, intracranial hemorrhage; SAE, serious adverse event.