Department of Neuroradiology, Royal Hallamshire Hospital, Sheffield, UK.
AJNR Am J Neuroradiol. 2012 Mar;33(3):474-80. doi: 10.3174/ajnr.A2836. Epub 2011 Dec 29.
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.
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.
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).
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.
本研究旨在系统评估改良线圈治疗颅内动脉瘤的临床和血管造影结果。我们报告了一项前瞻性随机对照试验的程序安全性和临床结果，该试验比较了载有聚合物的 Cerecyte 线圈与裸铂线圈在全球 23 个中心治疗破裂和未破裂颅内动脉瘤的效果。
500 名年龄在 18 至 70 岁之间的破裂或未破裂目标动脉瘤患者计划接受血管内线圈治疗，随机分配接受 Cerecyte 或裸铂线圈。分析采用意向治疗。
249 名患者被分配到 Cerecyte 线圈组，251 名患者被分配到裸铂线圈组。基线特征平衡。对于破裂性动脉瘤，Cerecyte 组住院死亡率为 2/114（1.8%），而裸铂线圈组为 0/119（0%）。有 8 例（3.4%）不良手术事件导致神经功能恶化：Cerecyte 组 5 例（4.4%），裸铂线圈组 3 例（2.5%）（P =.22）。Cerecyte 组 103/109（94.5%）患者和裸铂线圈组 110/112（98.2%）患者 6 个月 mRS 评分≤2 无显著差异。Cerecyte 组不良结局（mRS 评分≥3 或死亡）为 6/109（5.5%），裸铂线圈组为 2/112（1.8%）（P =.070）。对于 UIAs，无住院死亡率。神经功能恶化的不良手术事件有 7 例（2.7%），Cerecyte 组 5 例（3.8%），裸铂线圈组 2 例（1.5%）（P =.13）。Cerecyte 组 114/119（95.8%）患者和裸铂线圈组 123/123（100%）患者 6 个月 mRS 评分≤2。Cerecyte 组不良结局（mRS≥3 和 1 例死亡）为 5/119（4.2%），裸铂线圈组为 0/123（0%）（P =.011）。
破裂性动脉瘤组出院时和未破裂动脉瘤组 6 个月随访时，Cerecyte 组不良结局的统计学比例过高。两组的总体不良临床结局和住院死亡率均极低。
