dc.contributor.author | Coley, S. | |
dc.contributor.author | Sneade, M. | |
dc.contributor.author | Clarke, A. | |
dc.contributor.author | Mehta, Z. | |
dc.contributor.author | Kallmes, D. | |
dc.contributor.author | Cekirge, S. | |
dc.contributor.author | Saatci, I. | |
dc.contributor.author | Roy, D. | |
dc.contributor.author | Molyneux, A. | |
dc.date.accessioned | 2019-12-10T11:31:11Z | |
dc.date.available | 2019-12-10T11:31:11Z | |
dc.date.issued | 2012 | |
dc.identifier.issn | 0195-6108 | |
dc.identifier.uri | https://doi.org/10.3174/ajnr.A2836 | |
dc.identifier.uri | http://hdl.handle.net/11655/15858 | |
dc.description.abstract | BACKGROUND AND PURPOSE: This study arose from a need to systematically evaluate the clinical and angiographic outcomes of intracranial aneurysms treated with modified coils. We report the procedural safety and clinical outcomes in a prospective randomized controlled trial of endovascular coiling for ruptured and unruptured intracranial aneurysms, comparing polymer-loaded Cerecyte coils with bare platinum coils in 23 centers worldwide. MATERIALS AND METHODS: Five hundred patients between 18 and 70 years of age with a ruptured or unruptured target aneurysm planning to undergo endovascular coiling were randomized to receive Cerecyte or bare platinum coils. Analysis was by intention to treat. RESULTS: Two hundred forty-nine patients were allocated to Cerecyte coils and 251 to bare platinum coils. Baseline characteristics were balanced. For ruptured aneurysms, in-hospital mortality was 2/114 (1.8%) with Cerecyte versus 0/119 (0%) bare platinum coils. There were 8 (3.4%) adverse procedural events resulting in neurological deterioration: 5/114 (4.4%) with Cerecyte versus 3/119 (2.5%) with bare platinum coils (P = .22). The 6-month mRS score of <= 2 was not significantly different in 103/109 (94.5%) patients with Cerecyte and 110/112 (98.2%) patients with bare platinum coils. Poor outcome (mRS score of >= 3 or death) was 6/109 (5.5%) with Cerecyte versus 2/112 (1.8%) with bare platinum coils (P = .0701. For UlAs, there was no in-hospital mortality. There were 7 (2.7%) adverse procedural events with neurological deterioration, 5/133 (3.8%) with Cerecyte versus 2/131 (1.5%) with bare platinum coils (P = .13). There was a 6-month mRS score of <= 2 in 114/119 (95.8%) patients with Cerecyte versus 123/123 (100%) patients with bare platinum coils. There was poor outcome (mRS >= 3 and 1 death) in 5/119 (4.2%) patients with Cerecyte versus 0/123 (0%) patients with bare platinum coils (P = .011). CONCLUSIONS: There was a statistical excess of poor outcomes in the Cerecyte arm at discharge in the ruptured aneurysm group and at 6-month follow-up in the unruptured group. Overall adverse clinical outcomes and in-hospital mortality were exceptionally low in both groups. | |
dc.language.iso | en | |
dc.publisher | Amer Soc Neuroradiology | |
dc.relation.isversionof | 10.3174/ajnr.A2836 | |
dc.rights | info:eu-repo/semantics/openAccess | |
dc.subject | Neurosciences & Neurology | |
dc.subject | Radiology, Nuclear Medicine & Medical Imaging | |
dc.title | Cerecyte Coil Trial: Procedural Safety And Clinical Outcomes In Patients With Ruptured And Unruptured Intracranial Aneurysms | |
dc.type | info:eu-repo/semantics/article | |
dc.relation.journal | American Journal Of Neuroradiology | |
dc.contributor.department | Radyoloji | |
dc.identifier.volume | 33 | |
dc.identifier.issue | 3 | |
dc.identifier.startpage | 474 | |
dc.identifier.endpage | 480 | |
dc.description.index | WoS | |
dc.description.index | Scopus | |