Table 1.
Characteristics of the Included Studies and Outcome Events
| Trials | GREAT 2018 (DRKS00003132) | PRET 2017 (NCT00626912) | Poncyljusz’s RCT 2014 (EURR-6928) | HELP 2011 (ISRCTN30531382) |
|---|---|---|---|---|
| Regions | 22 centers in 2 countries | 25 centers in 6 countries | 1 centers in 1 country | 24 centers in 7 countries |
| Publication | Stroke | Am J Neuroradiol | European Journal of Radiology | Lancet |
| Inclusion Criteria | Ruptured or unruptured IAs; WFNS grade: 0–3; Age: 18–75 years; IA size: 4-12 mm in diameter; Endovascular occlusion is deemed possible; Neurointerventionist is content to use either HC or BPC. | Ruptured or unruptured IAs; WFNS grade: 0–3; Age: > 18 years; Life expectancy: > 2 years Endovascular occlusion is considered possible by both coils; Neurointerventionist is satisfied with using either HC or BPC but not other type. |
Only unruptured IAs; Endovascular occlusion is considered possible by both coils; Neurointerventionist is satisfied with using either HC or BPC but not other type. | Ruptured or unruptured IAs; Previously untreated IAs; Not pregnant; WFNS grade: 0–3; Age: 18–75 years; IA size: 2-25 mm in maximum diameter; Endovascular occlusion is deemed possible; Neurointerventionist is content to use either HC or BPC. |
| Exclusion Criteria | Patients already randomized in this trials; Pre-treated IA by coiling or clipping; More than one IAs need to be treated at the same treatment episode. | Other IAs requiring to be treated at the same treatment episode; Presence of AVM; Absolue contraindication to endovascular treatment. | Ruptured IAs; Intolerance to heparin or resistance to antiplatelet therapy, coagulopathies and abnormal platelet outcome. | Patients already randomized in this trials; More than one IAs need to be treated at the same treatment episode. |
| Study Design | Second-generation hydrogel coil (HydroSoft and/or HydroFrame) vs. Bare platinum coil | First or Second-generation hydrogel coil vs. Bare platinum coil | Hydrogel-coated coil vs. Bare platinum coil | First-generation hydrogel coil vs. Bare platinum coil |
| Efficacy outcomes | Complete occlusion, residual neck and residual aneurysm at periprecedure and 6–18 months; Recurrence, retreatment and mRS responese at 6–18 months. | Complete occlusion, residual neck and residual aneurysm at periprecedure; Recurrence, retreatment and mRS responese at 18 months. | Complete occlusion, residual neck and residual aneurysm at periprecedure and 12 months; Recurrence, retreatment and mRS responese at 12 months. | Complete occlusion, residual neck and residual aneurysm at periprecedure and 18 months; Recurrence, retreatment and mRS responese at 18 months. |
| Safety outcomes | Thromboembolic complications, coil migration, peforation, etc. at periprecedure; AEs, SAEs and death at periprocedure and 6-18 months. | Thromboembolic complications, hydrocephalus, peforation, etc. at periprecedure; AEs, SAEs and death at periprocedure and 18 months. | Thromboembolic complications, hydrocephalus, cerebral edema, etc. at periprecedure; AEs and death at periprocedure and 12 months. | Thromboembolic complications, artery occlusion, peforation, etc. at periprecedure; AEs and death at periprocedure and 18 months. |
GREAT German-French Randomized Endovascular Aneurysm Trial, PRET Patients prone to Recurrence after Endovascular Treatment, HELP Hydrocoil Endovascular aneurysm occLusion and Packing Study, WFNS World Federation of Neurosurgeons Societies, IA Intracranial aneurysm, AEs Adverse Events, SAEs Severe Adverse Events, AVM arteriovenous malformation, HC hydrogel coil, BPC Bare platinum coil