Article Figures & Data
Figures
- Fig 1.
Recruitment. Notice how recruitment decreased progressively from December 2010 to December 2013, a possible sign of case selection.
- Fig 2.
Flow chart. Diagram shows patient flow from randomization to periprocedural safety end points.
Tables
PRET-1 PRET-2 PRET Platinum Hydrogel Platinum Hydrogel Platinum Hydrogel Death Total 0 2 (1.6%) 0 0 0 2 (0.9%) Treatment-related 0 0 0 0 0 0 Morbidity (mRS > 2) Total 11 (8.8%) 5 (4.0%) 2 (2.1%) 5 (5.0%) 13 (5.9%) 10 (4.4%) Treatment-related 5 (4.0%) 2 (1.6%) 1 (1.0%) 2 (2.0%) 6 (2.7%) 4 (1.8%) Any stroke 11 (8.8%) 5 (4.0%) 8 (8.2%) 9 (9.0%) 19 (8.6%) 14 (6.2%) Any complication 8 (6.4%) 4 (3.2%) 1 (1.0%) 2 (2.0%) 9 (4.1%) 6 (2.7%) No complication 95 (76.0%) 107 (85.6%) 86 (88.7%) 83 (83.0%) 181 (81.5%) 190 (84.4%) Withdrawn 0 2 (1.6%) 0 1 (1.0%) 0 3 (1.3%) Fisher exact test P value .052 .612 .174 PRET-1 PRET-2 PRET Platinum Hydrogel Platinum Hydrogel Platinum Hydrogel Procedural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.
PRET-1 PRET-2 PRET Platinum Hydrogel Platinum Hydrogel Platinum Hydrogel No coiling, for any reason 3 (2.4%) 3 (2.4%) 0 5 (5.0%) 3 (1.4%) 8 (3.6%) Residual aneurysm 32 (25.6%) 39 (31.2%) 12 (12.4%) 14 (14.0%) 44 (19.8%) 53 (23.6%) Residual neck 48 (38.4%) 48 (38.4%) 40 (41.2%) 40 (40.0%) 88 (39.6%) 88 (39.1%) Complete obliteration 42 (33.6%) 35 (28.0%) 45 (46.4%) 41 (41.0%) 87 (39.2%) 76 (33.8%) Fisher exact test P value .723 .151 .280
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