Abstract
Coated coils have been in clinical use for several years without robust evidence to determine their safety/efficacy. The HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS) addresses this deficiency for the HydroCoil embolic system. This article reports periprocedural safety/operator-assessed angiographic results from HELPS. Patients were randomized to the hydrogel coil or control arms by using concealed allocation with minimization matching groups. Any bare platinum coils were allowed in the control arm, and assist devices could be used as clinically required. Both recently ruptured and not recently ruptured/unruptured aneurysms were included. Analysis was on an intention-to-treat basis. Four hundred ninety-nine patients were recruited. Coiling was successful in 98.6%. Mean aneurysm size was 6.5 mm (26% were > or =10 mm), 53% were recently ruptured aneurysms, and an assist device was used in 46%. Seventy procedural adverse events were reported in hydrogel coils and 86 in control arms. The 3-month mortality rate was 3.6% in hydrogel coils and 2.0% in control arms; the difference was not significant (P = .6). There was a lower 2-month mortality rate in the HELPS subarachnoid hemorrhage cohort (4.1%) than would be anticipated from the International Subarachnoid Aneurysm Trial (7%). There was a trend toward increased adverse events when assist devices were used, which was substantial for stents deployed in recently ruptured aneurysms. Ninety-six percent of patients discharged were World Federation of Neurosurgeons grade 0-2 at discharge. No difference was found between arms in the operator assessment of angiographic occlusions (P = .3). 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.
Highlights
AND PURPOSE: Coated coils have been in clinical use for several years without robust evidence to determine their safety/efficacy
There was a trend toward increased adverse events when assist devices were used, which was substantial for stents deployed in recently ruptured aneurysms
Coiling was attempted in 495/499 (99.2%) patients and was “successful”— defined as coils deployed in the aneurysm—in 492/495 (99.4%) patients
Summary
Patients were randomized to the hydrogel coil or control arms by using concealed allocation with minimization matching groups. Any bare platinum coils were allowed in the control arm, and assist devices could be used as clinically required. Both recently ruptured and not recently ruptured/unruptured aneurysms were included. Patients and Techniques HELPS is a pragmatic multicenter international randomized controlled trial of a policy of HydroCoil versus bare platinum in the endosaccular treatment of intracranial aneurysms. Any bare platinum coils with controlled detachment were permitted, as were any assist devices believed necessary by the operator, provided they had local regulatory approval. From the moment of randomization, the patient was in the trial and accounted for in the analysis (intention to treat). Groups were matched (minimization criteria) according to aneurysm size (2– 4.9, 5–9.9, and 10 –24.9 mm), neck size (dichotomized by dome-to-neck ratio Ͻ1.5 or Ն1.5), rupture status, aneurysm shape (multilobulated or not), planned use of an assist device, and whether randomized in the Americas (North and South combined)
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