Table 3.
Safety variables and serious adverse events within 90 days after randomization after removing centers with perceived endovascular equipoise shift.
| Variables | Intervention (n = 310) |
Control (n = 314) |
OR (95% CI) | p |
|---|---|---|---|---|
| Symptomatic intracranial hemorrhage at 24 ha, n (%) | 7 (2.3%) | 7 (2.2%) | 1.01 (0.35–2.92) | >0.99 |
| Symptomatic intracranial hemorrhage at 36 hb, n (%) | 8 (2.6%) | 8 (2.5%) | 1.01 (0.37–2.73) | >0.99 |
| Asymptomatic intracranial hemorrhage at 24 h, n (%) | 35 (11.3%) | 22 (7.0%) | 1.69 (0.97–2.95) | 0.07 |
| Death, n (%) | 48 (17.0%) | 43 (15.3%) | 1.14 (0.72–1.78) | 0.65 |
| Death due to serious adverse event, n (%) | 35 (11.3%) | 34 (10.8%) | 1.05 (0.63–1.73) | 0.90 |
| Serious adverse events, n (%) | 84 (27.1%) | 79 (25.2%) | 1.11 (0.77–1.58) | 0.59 |
| Cerebral edema, n (%) | 16 (5.2%) | 9 (2.9%) | 1.84 (0.80–4.24) | 0.16 |
| Brain herniation, n (%) | 11 (3.5%) | 4 (1.3%) | 2.85 (0.90–9.05) | 0.07 |
| Midline shift, n (%) | 8 (2.6%) | 9 (2.9%) | 0.90 (0.34–2.36) | >0.99 |
| Study discontinuation due to adverse events, n (%) | 19 (6.1%) | 25 (8.0%) | 0.75 (0.41–1.40) | 0.44 |
| Most common adverse event (headache), n (%) | 59 (19.0%) | 51 (16.2%) | 1.21 (0.80–1.83) | 0.40 |
| Second most common adverse event, (pyrexia), n (%) | 31 (10.0%) | 38 (12.1%) | 0.81 (0.49–1.33) | 0.44 |
| Third most common adverse event (nausea), n (%) | 39 (12.6%) | 23 (7.3%) | 1.82 (1.06–3.13) | 0.03 |
| Fourth most common adverse event (constipation), n (%) | 28 (9.0%) | 31 (9.9%) | 0.91 (0.53–1.55) | 0.78 |
| Fifth most common adverse event (pneumonia/aspiration pneumonia), n (%) | 33 (10.6%) | 25 (8.0%) | 1.38 (0.80–2.38) | 0.30 |
| Atrial fibrillation as adverse event, n (%) | 29 (9.3%) | 14 (4.5%) | 2.21 (1.14–4.27) | 0.02 |
| Atrial fibrillation as adverse event after exclusion of patients with atrial fibrillation at baseline, n (%) | 24 (7.7%) | 12 (3.8%) | 2.11 (1.04–4.30) | 0.04 |
Intervention: sonothrombolysis.
Control: intravenous thrombolysis.
sICH is defined as neurological deterioration (⩾4 points worsening on the NIHSS compared with the best prior examination) within 24 h after rt-PA bolus with documented parenchymal hemorrhage type 2 or type 2 remote (PH2/PH2r) where PH2 is defined as ICH volume at least one-third of the infarct volume, or death due to hemorrhage within 24 h after rt-PA bolus.
sICH is defined as neurological deterioration (⩾4 points worsening on the NIHSS compared with the best prior examination) within 36 h after rt-PA bolus with documented parenchymal hemorrhage type 2 or type 2 remote (PH2/PH2r) where PH2 is defined as ICH volume at least one-third of the infarct volume, or death due to hemorrhage within 36 h after rt-PA bolus.
CI, confidence interval; mRS, modified Rankin scale; NIHSS, National Institutes of Health Stroke Scale; OR, odds ratio; sICH, symptomatic intracranial hemorrhage; rt-PA, recombinant tissue plasminogen activator.