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PT  - JOURNAL ARTICLE
AU  - Coley, S.
AU  - Sneade, M.
AU  - Clarke, A.
AU  - Mehta, Z.
AU  - Kallmes, D.
AU  - Cekirge, S.
AU  - Saatci, I.
AU  - Roy, D.
AU  - Molyneux, A.
TI  - Cerecyte Coil Trial: Procedural Safety and Clinical Outcomes in Patients with Ruptured and Unruptured Intracranial Aneurysms
AID  - 10.3174/ajnr.A2836
DP  - 2012 Mar 01
TA  - American Journal of Neuroradiology
PG  - 474--480
VI  - 33
IP  - 3
4099  - http://www.ajnr.org/content/33/3/474.short
4100  - http://www.ajnr.org/content/33/3/474.full
SO  - Am. J. Neuroradiol.2012 Mar 01; 33
AB  - 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 = .070). For UIAs, 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. CCTCerecyte Coil TrialIQRinterquartile rangeISATInternational Subarachnoid Aneurysm TrialmRSmodified Rankin ScalePGApolyglycolic acidRCTrandomized controlled trialUIAunruptured intracranial aneurysmWFNSWorld Federation of Neurosurgical Societies