GREAT Study:
Randomized controlled multicentre study comparing HydroSoft™ / HydroFrame™ and bare platinum coils for endovascular aneurysm treatment
Hydrogel Embolic Coils
"Our results suggest that endovascular coil embolization with second-generation hydrogel coils may reduce the rate of unfavorable outcome events in patients with small- and medium-sized intracranial aneurysms."
- Patients
484
- Countries
France & Germany
- Clinical Centers
22
- Design
RCT (243 HES vs 241 BPC)
- Scope
Patients 18-75 y.o. with an untreated aneurysm, ruptured or unruptured, with a dimater between 4 and 12mm, WFNS <4.
- Purpose
To compare clinical and angiographic outcomes of second-generation Hydrocoils (HydroSoft™ and Hydroframe™) versus bare platinum coils.
Endpoints
Composite outcome: Major aneurysm recurrence on follow-up angiography + any aneurysm retreatment + morbidity that prevented patients from having angiographic controls (mRS between 3 and 5) + any death within 18 months after treatment.
Efficacy results
At 18 months:
Unfavorable composite primary outcome (recurrence, retreatment, morbidity, mortality): 19.9% (HES) vs 28.7% (BPC)
Complete occlusion: 69% (HES) vs 53% (BPC)
Major recurrence: 12% (HES) vs 18% (BPC)
Retreatment rate: 3% (HES) vs 6% (BPC)
Safety results
Procedural complications: 12.7% (HES) vs 12.4% (BPC)
14-day mortality rate: 2.0% (HES) vs 2.1% (BPC)
At 18 months:
mRS 3-5: 3% (HES) vs 1% (BPC)
mRS 6: 3% (HES) vs 4% (BPC)
Rupt. An (within 30 days):
mRS 3-5: 5% (HES) vs 2% (BPC)
mRS 6: 5% (HES) vs 7% (BPC)
Unrupt. An:
mRS 3-5: 1% (HES) vs 1% (BPC)
mRS 6: 1% (HES) vs 2% (BPC)
Study publications
SPONSOR: Freiburg Hospital Germany
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