DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Hydrogel-coated coils versus bare platinum coils for the endovascular treatment of intracranial aneurysms (HELPS): a randomised controlled trial.

Author(s): White PM, Lewis SC, Gholkar A, Sellar RJ, Nahser H, Cognard C, Forrester L, Wardlaw JM

Affiliation(s): Department of Neuroradiology and University Department of Clinical Neurosciences, Western General Hospital, University of Edinburgh SINAPSE Collaboration, Edinburgh, UK. pwhite1@staff mail.ed.ac.uk

Publication date & source: 2011-05-14, Lancet., 377(9778):1655-62.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: Coated coils for endovascular treatment of cerebral aneurysm were developed to reduce recurrence and retreatment rates, and have been in clinical use for 8-9 years without robust evidence to determine their efficacy. We assessed the efficacy and safety of hydrogel-coated coils. METHODS: This randomised trial was undertaken in 24 centres in seven countries. Patients aged 18-75 years with a previously untreated ruptured or unruptured cerebral aneurysm of 2-25 mm in maximum diameter were randomly allocated (1:1) to aneurysm coiling with either hydrogel-coated coils or standard bare platinum coils (control). Randomisation was done with a computer-generated sequence, stratified by aneurysm size, shape, and dome-to-neck ratio; intention to use assist device; and by region. Participants and those assessing outcomes were masked to allocation. Analysis was by modified intention to treat (excluding missing data). Primary outcome was a composite of angiographic and clinical outcomes at 18-month follow-up. We also did prespecified subgroup analyses of characteristics likely to be relevant to angiographic outcome. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN30531382. FINDINGS: 249 patients were allocated to the hydrogel coil group and 250 to the control group. In 44 of 467 patients for whom an 18-month composite primary outcome was unavailable, 6-month angiographic results were used. 70 (28%) patients in the hydrogel group and 90 (36%) control patients had an adverse composite primary outcome, giving an absolute reduction in the proportion of adverse composite primary outcomes with hydrogel of 7.0% (95% CI -1.6 to 15.5), odds ratio (OR) 0.73 (0.49-1.1, p=0.13). In a prespecified subgroup analysis in recently ruptured aneurysms, there were more adverse composite primary outcomes in the control group than in the hydrogel group-OR 2.08 (1.24-3.46, p=0.014). There were 8.6% fewer major angiographic recurrences in patients allocated to hydrogel coils-OR 0.7 (0.4-1.0, p=0.049). There were five cases of unexplained hydrocephalus in not-recently-ruptured aneurysms in the hydrogel coil group and one case in the control group. INTERPRETATION: Whether use of hydrogel coils reduces late aneurysm rupture or improves long-term clinical outcome is not clear, but our results indicate that their use lowers major recurrence. FUNDING: MicroVention Inc. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

Page last updated: 2011-12-09

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017