6/28/23, 11:02 PM HEAT (intracranial aneurysm) Pathway Feedback Search Clinical Topics Home Studies HEAT (intracranial aneurysm) HEAT (intracranial aneurysm) 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 N = 600 21.0% male 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 15.4 % 15.4 11.6 % 7.7 % Significant decrease 4.4 3.9 % NNT = 9 0.0 % https://web.pathway.md/studies/rec7laTFHmiKza2ar 1/2 6/28/23, 11:02 PM HEAT (intracranial aneurysm) Pathway Hydrogel coil Bare platinum 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. Open reference URL https://web.pathway.md/studies/rec7laTFHmiKza2ar 2/2