Cerecyte coil trial: procedural safety and clinical outcomes in patients with ruptured and unruptured intracranial aneurysms.

Coley, S; Sneade, M; Clarke, A; Mehta, Z; Kallmes, D; Cekirge, S; Saatci, I; Roy, D; Molyneux, A

Journal article

Cerecyte coil trial: procedural safety and clinical outcomes in patients with ruptured and unruptured intracranial aneurysms.

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 = .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.

Publication status:: Published

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APA Style

Coley, S., Sneade, M., Clarke, A., Mehta, Z., Kallmes, D., Cekirge, S., Saatci, I., Roy, D., & Molyneux, A. (2012). Cerecyte coil trial: procedural safety and clinical outcomes in patients with ruptured and unruptured intracranial aneurysms. AJNR. American Journal of Neuroradiology, 33(3), 474–480.

MLA Style

Coley, S., et al. “Cerecyte Coil Trial: Procedural Safety and Clinical Outcomes in Patients with Ruptured and Unruptured Intracranial Aneurysms.” AJNR. American Journal of Neuroradiology, vol. 33, no. 3, 2012, pp. 474–80.

Chicago Style

Coley, S, M Sneade, A Clarke, Z Mehta, D Kallmes, S Cekirge, I Saatci, D Roy, and A Molyneux. 2012. “Cerecyte Coil Trial: Procedural Safety and Clinical Outcomes in Patients with Ruptured and Unruptured Intracranial Aneurysms.” AJNR. American Journal of Neuroradiology 33 (3): 474–80.
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