Primary safety endpoint events through 12 months and primary safety analysis of neurological death and disabling stroke (CEC-adjudicated safety population)
| Analysis using prespecified primary safety endpoint definition | n=145 n (%) | Posterior Mean (95% CI) | Posterior probability* |
| Primary safety† | 9 (6.2%) | 6.8% (3.3% to 11.3%) | 0.999 |
| Primary safety components: | |||
| Major stroke within 30 days | 6 (4.1%) | 4.8% (1.9% to 8.7%) | |
| Death within 30 days | 0 | 0.7% (0.0% to 2.5%) | |
| Major ipsilateral stroke 31–425 days | 3 (2.1%) | 2.7% (0.7% to 5.8%) | |
| Neurological death 31–425 days‡ | 1 (0.7%) | 1.4% (0.2% to 3.7%) | |
| Additional primary safety analysis using composite rate of neurological death and any disabling stroke (mRS score ≥3) | |||
| Primary safety | 4 (2.8%) | ||
| Primary safety components: | |||
| Major stroke within 30 days | 2 (1.4%) | ||
| Death within 30 days | 0 | ||
| Major ipsilateral stroke 31–425 days | 2 (1.4%) | ||
| Neurological death 31–425 days‡ | 1 (0.7%) |
*Posterior probability that the primary safety endpoint event rate is <15%.
†Primary safety endpoint defined as rate of death or major stroke within 30 days or neurologic death or major ipsilateral stroke within 12 months.
‡One subject fell and had a major ipsilateral stroke (subdural hematoma) at day 235 postoperatively with subsequent neurological death 1 day later and is listed under both stroke and death 31–425 days for this event.
CEC, Clinical Events Committee; mRS, modified Rankin Scale.