Adverse eventsa
PRET-1 | PRET-2 | PRET | ||||
---|---|---|---|---|---|---|
Platinum (n = 125) | Hydrogel (n = 123) | Platinum (n = 97) | Hydrogel (n = 99) | Platinum (n = 222) | Hydrogel (n = 222) | |
Total | 24 (19.2%) | 26 (21.1%) | 13 (13.4%) | 15 (15.2%) | 37 (16.7%) | 41 (18.5%) |
SAH during follow-up | 1 (0.8%) | 0 (0.0%) | 1 (1.0%) | 2 (2.0%) | 2 (0.9%) | 2 (0.9%) |
Mass effect | 0 (0.0%) | 1 (0.8%) | 2 (2.1%) | 0 (0.0%) | 2 (0.9%) | 1 (0.5%) |
Stroke | 1 (0.8%) | 2 (1.6%) | 1 (1.0%) | 0 (0.0%) | 2 (0.9%) | 2 (0.9%) |
TIA | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (1.0%) | 0 (0.0%) | 1 (0.5%) |
Inflammatory | 2 (1.6%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 2 (0.9%) | 0 (0.0%) |
Subdural hematoma | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (1.0%) | 0 (0.0%) | 1 (0.5%) |
Non-neurologic | 3 (2.4%) | 1 (0.8%) | 0 (0.0%) | 0 (0.0%) | 3 (1.4%) | 1 (0.5%) |
Retreatment-related | 1 (0.8%) | 4 (3.3%) | 2 (2.1%) | 1 (1.0%) | 3 (1.4%) | 5 (2.3%) |
Periprocedural event | 16 (12.8%) | 18 (14.6%) | 7 (7.2%) | 10 (10.1%) | 23 (10.4%) | 28 (12.6%) |
Serious | 15 (12.0%) | 15 (12.2%) | 5 (5.2%) | 10 (10.1%) | 20 (9.0%) | 25 (11.3%) |
Delayed | 5 (4.0%) | 7 (5.7%) | 2 (2.1%) | 4 (4.0%) | 7 (3.2%) | 11 (5.0%) |
Periprocedure | 10 (8.0%) | 8 (6.5%) | 3 (3.1%) | 6 (6.1%) | 13 (5.9%) | 14 (6.3%) |
↵a Adverse events were recorded during the trial. Periprocedural events (within 1 month of procedure) are lumped together. Data are numbers.