Table 3.
Safety endpoints
| Total | IV-IA | IA only | P-value | |
|---|---|---|---|---|
| Primary | ||||
| Device or procedure-related serious adverse events | 7.4% (15/202) | 6.7% (8/119) | 8.4% (7/83) | 0.786 |
| Procedure-related serious adverse events | 5.4% (11/202) | 5.9% (7/119) | 4.8% (4/83) | 1.000 |
| Solitaire Device-related serious adverse events* | 2.5% (5/202) | 2.5% (3/119) | 2.4% (2/83) | 1.000 |
| Embolus to uninvolved territory | 1.0% (2/202) | 0.0% (0/119) | 2.4% (2/83) | 0.168 |
| Intracranial hemorrhage | 1.0% (2/202) | 1.7% (2/119) | 0.0% (0/83) | 0.513 |
| Vessel dissection | 1.0% (2/202) | 0.8% (1/119) | 1.2% (1/83) | 1.000 |
| Secondary | ||||
| Intracranial hemorrhage as per CEC adjudication | 18.8% (38/202) | 18.5% (22/119) | 19.3% (16/83) | 1.000 |
| HI-1 | 9.4% (19/202) | 8.4% (10/119) | 10.8% (9/83) | 0.627 |
| HI-2 | 5.0% (10/202) | 5.0% (6/119) | 4.8% (4/83) | 1.000 |
| PH-1 | 3.0% (6/202) | 4.2% (5/119) | 1.2% (1/83) | 0.404 |
| IVH + PH-2 | 0.5% (1/202) | 0.8% (1/119) | 0.0% (0/83) | 1.000 |
| SAH | 3.0% (6/202) | 2.5% (3/119) | 3.6% (3/83) | 0.691 |
| Symptomatic per CEC adjudication** | 1.5% (3/202) | 1.7% (2/119) | 1.2% (1/83) | 1.000 |
| Death from any cause by 90 days | 6.9% (14/202) | 5.9% (7/119) | 8.4% (7/83) | 0.577 |
*
One patient presented two events.
**
Classified according to ECASS trials definition