Table 2

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 definitionn=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 days6 (4.1%)4.8% (1.9% to 8.7%)
 Death within 30 days00.7% (0.0% to 2.5%)
 Major ipsilateral stroke 31–425 days3 (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 safety4 (2.8%)
Primary safety components:
 Major stroke within 30 days2 (1.4%)
 Death within 30 days0
 Major ipsilateral stroke 31–425 days2 (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.