Procedure-related adverse events and mortality: comparison of assist device versus unassisted coiling cases
| Randomized Treatment | |||||
|---|---|---|---|---|---|
| Hydrogel | Bare Platinum | Absolute Difference | |||
| No. | % | No. | % | (95% CI) | |
| Procedure-related adverse event | |||||
| Stent used in acutely ruptured aneurysm | 2/3 | 66.7 | 2/3 | 66.7 | 0% (−53% to +53%) |
| Stent used in unruptured aneurysm | 7/43 | 16.3 | 9/49 | 18.4 | −2.1% (−17% to +14%) |
| Balloon/other assist used in acutely ruptured aneurysm | 9/32 | 28.1 | 8/30 | 26.7 | +1.5% (−20% to +23%) |
| Balloon/other assist used in unruptured aneurysm | 9/38 | 23.7 | 6/31 | 19.4 | +4.3% (−16% to +23%) |
| No assist device, acutely ruptured aneurysm | 18/104 | 17.3 | 22/101 | 21.8 | −4.5% (−15% to +6.4%) |
| No assist device, unruptured aneurysm | 2/28 | 7.1 | 6/34 | 17.6 | −10.5% (−27% to +7.6%) |
| Mortality rate (0–3 months) | |||||
| Stent used in acutely ruptured aneurysm | 2/3 | 66.7 | 2/3 | 66.7 | 0% (−53% to +53%) |
| Stent used in unruptured aneurysm | 0/43 | 0 | 1/49 | 2.0 | −2% (−11% to +6.3%) |
| Balloon/other assist used in acutely ruptured aneurysm | 4/32 | 12.5 | 1/30 | 3.3 | +9.2% (−6.1% to +25%) |
| Balloon/other assist used in unruptured aneurysm | 1/38 | 2.6 | 0/31 | 0 | +2.6% (−8.6% to +14%) |
| No assist device, acutely ruptured aneurysm | 2/104 | 1.9 | 1/101 | 1.0 | +0.9% (−3.7% to +5.8%) |
| No assist device, unruptured aneurysm | 0/28 | 0 | 0/34 | 0 | 0% (−10% to +12%) |
Note:—CI indicates confidence interval.