Table 4:
Safety: Stroke and Other Significant Adverse Events
| All Unruptured Aneurysms |
Wide-Neck Aneurysms |
|||||
|---|---|---|---|---|---|---|
| Stent-Coil (n = 137) | Coil Alone (n = 224) | P Value | Stent-Coil (n = 85) | Coil Alone (n = 73) | P Value | |
| Periprocedural significant adverse event rate | 6.6% | 4.5% | .39 | 3.7% | 0.89% | .11 |
| 1-Year hemorrhagic stroke rate | 2.9% | 0.4% | .07 | 2.4% | 0.0% | .50 |
| 1-Year ischemic stroke rate | 8.8% | 2.2% | .005 | 11.8% | 4.1% | .08 |
| if problem site is excludeda | ||||||
| 1-Year ischemic stroke rate | 6.2% | 2.2% | .11 | 8.8% | 4.1% | .31 |
a
One enrolling site accounted for 5 of 12 subjects with ischemic stroke in the unruptured aneurysm group. All ischemic strokes at that site occurred ≥7 days after the procedure.