Table 4:

Safety: Stroke and Other Significant Adverse Events

All Unruptured AneurysmsWide-Neck Aneurysms
Stent-Coil (n = 137)Coil Alone (n = 224)P ValueStent-Coil (n = 85)Coil Alone (n = 73)P Value
Periprocedural significant adverse event rate6.6%4.5%.393.7%0.89%.11
1-Year hemorrhagic stroke rate2.9%0.4%.072.4%0.0%.50
1-Year ischemic stroke rate8.8%2.2%.00511.8%4.1%.08
    if problem site is excludeda
1-Year ischemic stroke rate6.2%2.2%.118.8%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.