HES Coils

HELPS: HydroCoil Endovascular Aneurysm Occlusion and Packing Study

"These HELPS results reinforce coiling as an effective treatment for aneurysms, with an excellent technical success rate. Hydrogel coils can be used in a wide spectrum of aneurysms with a risk profile equivalent to that of bare platinum."

Patients

499

Countries

UK, US, France, Brazil, Germany, Australia, Argentina

Clinical Centers

Design

RCT (249 HES vs 250 BPC)

Scope

Patients 18-75 y.o., with ruptured or unruptured aneurysms of 2-25mm, WFNS 0-3.

For AN. 2-9.9mm: Hydrogel arm targeted to have > 50% packing w/gel or > 50% gel length deployed. For AN. ≥10mm: Hydrogel arm targeted to have > 2/3 gel length deployed or >70% packing w/gel.

Purpose

Compare safety and efficacy of HydroCoil vs platinum.

Endpoints

Composite outcome: Major aneurysm recurrence (Recurrence defined as adequate space in the aneurysm to deploy further coils) + morbidity/mortality preventing angiographic f/u, at 18 months

Efficacy results

Major recurrence at 18 months: 24% HES vs 33% BPC
Primary outcome event at 18 months: 28% HES vs 36% BPC
Packing density: 63.9% HES vs 23.2% BPC
Retreatment: 3.0% HES vs 4.0% BPC including cross-over (patients who switched treatment group)