HEAT (second-generation hydrogel coils)
Trial question
Is second-generation hydrocoil embolic system superior to bare platinum coil in patients with small-to-medium-sized intracranial aneurysms?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
79.0% female
21.0% male
N = 600
600 patients (474 female, 126 male).
Inclusion criteria: adult patients with untreated 3-to-14-mm intracranial aneurysms.
Key exclusion criteria: concurrent intracranial pathologies; serious comorbidities.
Interventions
N=297 hydrogel coil (aneurysm treatment using the HydroCoil Embolization System).
N=303 bare platinum (aneurysm treatment using bare platinum coil(s)).
Primary outcome
Aneurysm recurrence
4.4%
15.4%
15.4 %
11.6 %
7.7 %
3.9 %
0.0 %
Hydrogel
coil
Bare
platinum
Significant
decrease ▼
NNT = 9
Significant decrease in aneurysm recurrence (4.4% vs. 15.4%; OR 0.29, 95% CI 0.11 to 0.47).
Secondary outcomes
Significant decrease in aneurysm occlusion stability (13% vs. 27%; OR 0.48, 95% CI 0.2 to 0.76).
Significant decrease in minor recurrence (1% vs. 5%; OR 0.2, 95% CI 0.06 to 0.34).
Significant decrease in major recurrence (12.8% vs. 20.7%; OR 0.62, 95% CI 0.12 to 1.12).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients with untreated 3-to-14-mm intracranial aneurysms, hydrogel coil was superior to bare platinum with respect to aneurysm recurrence.
Reference
Bernard R Bendok, Karl R Abi-Aad, Jennifer D Ward et al. The Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): A Randomized Controlled Trial of the Second-Generation Hydrogel Coil. Neurosurgery. 2020 May 1;86(5):615-624.
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