Table 4:

Deaths within 3 months of endovascular procedure

Randomized Treatment
HydrogelBare PlatinumAbsolute Difference
No.%No.%(95% CI)
Total no. patients randomized249250
Died within 3 months of procedure*93.652.01.6% (−1.5% to +4.9%)
    Procedure-related/exacerbated (eg, rupture, rebleed) (−1.2% to +3.9%)
    Disease-related41.631.20.4% (−2.1% to +3.0%)
Deaths by target aneurysm rupture status
    Aneurysm ruptured <30 days before randomization8/1326.14/1333.03.1% (−2.3% to +8.8%)
    Did not rupture <30 days before randomization1/1170.91/1170.90.0% (−3.9% to +3.9%)
  • Note:—CI indicates confidence interval.

  • * All these 14 patients were coiled on the day of randomization.

  • Test for interaction (to find whether the effect of treatment differs between subgroups); P = .6 from logistic regression.

  • The patient in the hydrogel coil arm “not recently ruptured” who died was baseline WFNS 1 but died before discharge. The patient in control arm “not recently ruptured” who died was WFNS 0 and was discharged the day after the procedure but bled 9 days later and died. The intracerebral bleed was not thought to be from the target aneurysm.