Safety indices reported at time of the procedure and during follow-up
PRET-1 | PRET-2 | PRET | ||||
---|---|---|---|---|---|---|
Platinum | Hydrogel | Platinum | Hydrogel | Platinum | Hydrogel | |
Procedural complications | ||||||
Thromboembolic | 10 (8.0%) | 6 (4.9%) | 1 (1.0%) | 3 (3.0%) | 11 (5.0%) | 9 (4.1%) |
Hemorrhagic | 2 (1.6%) | 1 (0.8%) | 1 (1.0%) | 1 (1.0%) | 3 (1.4%) | 2 (0.9%) |
Other | 4 (3.2%) | 6 (4.9%) | 4 (4.1%) | 3 (3.0%) | 8 (3.6%) | 9 (4.1%) |
Anti-GP IIb/IIIa used during embolization | 8 (6.4%) | 11 (8.9%) | 7 (7.2%) | 4 (4.0%) | 15 (6.8%) | 15 (6.8%) |
Clinical deterioration at end of procedure | 5 (4.0%) | 1 (0.8%) | 2 (2.1%) | 3 (3.0%) | 7 (3.2%) | 4 (1.9%) |
Hospitalization | ||||||
Days (median) (min) (max) | 2 (1) (94) | 1 (0) (70) | 1 (0) (51) | 1 (0) (30) | 1 (0) (94) | 1 (0) (70) |
Days >5 for unruptured aneurysms | 9 (7.2%) | 7 (5.7%) | 5 (5.2%) | 5 (5.1%) | 14 (6.3%) | 12 (5.4%) |
Days >15 for ruptured aneurysms | 10 (8.0%) | 10 (8.1%) | 1 (1.0%) | 0 | 11 (5.0%) | 10 (4.5%) |
New imaging findings at discharge | 17 (13.6) | 11 (8.9%) | 7 (7.2%) | 9 (9.1%) | 24 (10.8%) | 20 (9.0%) |
mRS >2 at discharge | 17 (13.6%) | 9 (7.3%) | 1 (1.0%) | 5 (5.1%) | 18 (8.1%) | 14 (6.3%) |
Discharge destination | ||||||
Home | 107 (85.6%) | 108 (87.8%) | 95 (97.9%) | 92 (92.9%) | 202 (91.0%) | 200 (90.1%) |
Other than home | 18 (14.4%) | 15 (12.2%) | 2 (2.1%) | 7 (7.1%) | 20 (9.0%) | 22 (9.2%) |
mRS >2 at 1 month | 11 (8.8%) | 6 (4.9%) | 3 (3.1%) | 5 (5.1%) | 14 (6.3%) | 11 (5%) |
Location at 1 month | ||||||
Home | 117 (93.6%) | 116 (94.3%) | 95 (97.9%) | 95 (96.0%) | 212 (95.5%) | 211 (95.0%) |
Other than home | 8 (6.4%) | 7 (5.7%) | 2 (2.1%) | 4 (4.0%) | 10 (4.5%) | 11 (5%) |
AE | ||||||
No. reported | 16 | 18 | 7 | 10 | 23 | 28 |
No. (%) serious | 10 (62%) | 8 (44.4%) | 3 (42.9%) | 6 (60%) | 13 (56.5%) | 14 (50%) |
AE attribution (No.) (% of total No. reported) | ||||||
Related to treatment | 14 (87.5%) | 14 (77.8%) | 7 (100%) | 10 (100%) | 21 (91.3%) | 24 (85.7%) |
Related to aneurysm | 2 (12.5%) | 3 (16.7%) | 0 | 0 | 2 (8.7%) | 3 (10.7%) |
Unrelated | 0 | 1 (5.5%) | 0 | 0 | 0 | 1 (3.6%) |
Note:—Anti-GP IIb/IIIa indicates antiglycoprotein IIb/IIIa; AE, adverse events; min, minimum; max, maximum.