TABLE 3.
Primary and Secondary Outcomes
| HydroCoil Embolic System | Bare platinum coils | P value | |
|---|---|---|---|
| Recurrence: any progression on the RR scale | 4.4% | 15.4% | .002 |
| Occlusion stability: any increase on the Meyers scale | 13% | 27% | <.001 |
| Minor recurrence: progression on the RR scale from 1 to 2 | 2 (1.0%) | 14 (5.0%) | .004 |
| Major recurrence: progression on the RR scale to 3, or a 3 with an increase in the Meyers scale | 32 (12.8%) | 55 (20.7%) | .016 |
| Packing density | 32.5% ± 14.8% | 24.7% ± 10.2% | <.001 |
| Initial occlusion | 50 (17.8%) | 82 (28.3%) | .003 |
| Occlusion stability | <.001 | ||
| 3-12 mo | 64.9% | 49.0% | |
| 18-24 mo | 68.6% | 51.5% | |
| Patients with adverse eventsa | 64 (21.6%) | 75 (24.8%) | .352 |
| Adverse events per persona | |||
| None | 233 (78.5%) | 228 (75.3%) | .294 |
| One | 44 (14.8%) | 63 (20.8%) | |
| Two | 19 (6.4%) | 8 (2.6%) | |
| Three | 1 (0.3%) | 4 (1.3%) | |
| Mortality | 7 (2.4%) | 9 (3.0%) | .641 |
| Clinical outcome | .578 | ||
| No symptoms | 181 (63.1%) | 178 (61.0%) | |
| No significant disability | 60 (20.9%) | 63 (21.6%) | |
| Slight disability | 24 (8.4%) | 28 (9.6%) | |
| Moderate disability | 13 (4.5%) | 10 (3.4%) | |
| Moderately severe disability | 2 (0.7%) | 0 (0%) | |
| Severe disability | 0 (0%) | 4 (1.4%) | |
| Expired | 7 (2.4%) | 9 (3.1%) | |
| Retreatment | 13 (5.2%) | 22 (8.3%) | .162 |
| Hemorrhagea | 5 (1.7%) | 4 (1.3%) | .714 |
aEvent related to device and/or procedure.