Baseline characteristics of patients and aneurysms
| PRET-1 | PRET-2 | PRET | ||||
|---|---|---|---|---|---|---|
| Platinum | Hydrogel | Platinum | Hydrogel | Platinum | Hydrogel | |
| Total No. patients randomized | 125 | 125 | 97 | 100 | 222 | 225 |
| Male sex | 35 (28.0%) | 33 (26.4%) | 33 (34%) | 27 (27.0%) | 68 (30.6%) | 60 (26.7%) |
| Mean age (SD) (yr) | 59 (11) | 58 (11) | 57 (12) | 56 (10) | 58 (12) | 57 (11) |
| Multiple aneurysms | 36 (28.8%) | 36 (28.8%) | 23 (23.7%) | 22 (22.0%) | 59 (26.6%) | 58 (25.8%) |
| Ruptured aneurysms | ||||||
| No. (%) of treatment group | 37 (29.6%) | 35 (28%) | 2 (2.1%) | 5 (5.0%) | 39 (17.6%) | 40 (17.8%) |
| No. (%) WFNS > II | 3 (8.1%) | 8 (22.9%) | 0 | 0 | 3 (7.7%) | 8 (20.0%) |
| Unruptured aneurysms | ||||||
| mRS at baseline 0–2 | 85 (96.6%) | 90 (100.0%) | 94 (98.9%) | 94 (98.9%) | 179 (97.8%) | 184 (99.5%) |
| mRS at baseline 3–5 | 3 (3.4%) | 0 | 1 (1.1%) | 1 (1.1%) | 4 (2.2%) | 1 (0.5%) |
| No. (%) symptomatic | 24 (27.3%) | 18 (20%) | 8 (8.4%) | 9 (9.5%) | 32 (17.5%) | 27 (14.6%) |
| Aneurysm size (maximal dimension) | ||||||
| Mean (SD) (mm) | 13.3 (4.9) | 12.7 (4.3) | 8.6 (5.8) | 8.3 (5.5) | 11.3 (5.8) | 10.7 (5.3) |
| ≥10 mm | 97 (77.6%) | 96 (76.8%) | 29 (29.9%) | 25 (25.0%) | 126 (56.8%) | 121 (53.8%) |
| 1.0–9.9 mma | 28 (22.4%) | 29 (23.2%) | 68 (70.1%) | 75 (75.0%) | 96 (43.2%) | 104 (46.2%) |
| 10.0–14.9 mm | 59 (47.2%) | 66 (52.8%) | 16 (16.5%) | 14 (14.0%) | 75 (33.8%) | 80 (35.6%) |
| 15.0–19.9 mm | 25 (20.0%) | 24 (19.2%) | 5 (5.2%) | 7 (7.0%) | 30 (13.5%) | 31 (13.8%) |
| 20.0–24.9 mm | 8 (6.4%) | 4 (3.2%) | 6 (6.2%) | 1 (1.0%) | 14 (6.3%) | 5 (2.2%) |
| ≥25 mm | 5 (4.0%) | 2 (1.6%) | 2 (2.1%) | 3 (3.0%) | 7 (3.2%) | 5 (2.2%) |
| Aneurysm neck | ||||||
| Mean (SD) (mm) | 5.0 (2.1) | 4.8 (1.6) | 4.5 (2.5) | 4.6 (2.3) | 4.8 (2.3) | 4.7 (1.9) |
| Neck ≥4.0 (mm) | 88 (70.4%) | 94 (75.2%) | 53 (54.6%) | 58 (58.0%) | 141 (63.5%) | 152 (67.6%) |
| Aneurysm location, anterior | 96 (76.8%) | 104 (83.2%) | 69 (71.1%) | 70 (70.0%) | 165 (74.3%) | 174 (77.3%) |
| Internal carotid | 58 (46.4%) | 69 (55.2%) | 43 (44.3%) | 40 (40.0%) | 101 (45.5%) | 109 (48.4%) |
| Anterior cerebral | 23 (18.4%) | 18 (14.4%) | 21 (21.6%) | 24 (24.0%) | 44 (19.8%) | 42 (18.7%) |
| Middle cerebral | 15 (12.0%) | 17 (13.6%) | 5 (5.2%) | 6 (6.0%) | 20 (9.0%) | 23 (10.2%) |
| Aneurysm location, posterior | 29 (23.2%) | 21 (16.8%) | 28 (28.9%) | 30 (30.0%) | 57 (25.7%) | 51 (22.7%) |
| Basilar | 23 (18.4%) | 13 (10.4%) | 21 (21.6%) | 19 (19.0%) | 44 (19.8%) | 32 (14.2%) |
| Other posterior | 6 (4.8%) | 8 (6.4%) | 7 (7.2%) | 11 (11.0%) | 13 (5.9%) | 19 (8.4%) |
| Intended use of adjunct device | 41 (32.8%) | 42 (33.6%) | 35 (36.1%) | 38 (38.0%) | 76 (34.2%) | 80 (35.6%) |
Note:—WFNS indicates World Federation of Neurological Societies.
↵a PRET-1 aneurysms recruited as ≥10 mm on noninvasive imaging have been measured using fiducials as <10 mm by the core laboratory; median size was 8.6 mm (mean, 8.3 ± 1.3 mm).