Randomized Treatment | |||||
---|---|---|---|---|---|
Hydrogel | Bare Platinum | Absolute Difference | |||
No. | % | No. | % | (95% CI) | |
Total no. patients randomized | 249 | 250 | |||
Died within 3 months of procedure*† | 9 | 3.6 | 5 | 2.0 | 1.6% (−1.5% to +4.9%) |
Procedure-related/exacerbated (eg, rupture, rebleed) | 5 | 2.0 | 2 | 0.8 | 1.2% (−1.2% to +3.9%) |
Disease-related | 4 | 1.6 | 3 | 1.2 | 0.4% (−2.1% to +3.0%) |
Deaths by target aneurysm rupture status† | |||||
Aneurysm ruptured <30 days before randomization | 8/132 | 6.1 | 4/133 | 3.0 | 3.1% (−2.3% to +8.8%) |
Did not rupture <30 days before randomization‡ | 1/117 | 0.9 | 1/117 | 0.9 | 0.0% (−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.