Cerecyte Coil Trial: Procedural Safety and Clinical Outcomes in Patients with Ruptured and Unruptured Intracranial Aneurysms
Cerecyte Coil Trial: Procedural Safety and Clinical Outcomes in Patients with Ruptured and Unruptured Intracranial Aneurysms
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DOI：
10.3174/ajnr.a2836
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发表时间：
2012-03-01
影响因子：
3.5
通讯作者：
Molyneux, A.
中科院分区：
文献类型：
--
作者：
Coley, S.;Sneade, M.;Molyneux, A.
背景和目的：本研究源于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的需要。我们报告了一项前瞻性随机对照试验的手术安全性和临床结果，该试验对破裂和未破裂的颅内动脉瘤进行了血管内卷曲，比较了全球23个中心的聚合物负载Cerecyte线圈和裸铂线圈。材料和方法：500名年龄在18至70岁之间的目标动脉瘤破裂或未破裂的患者计划接受血管内缠绕术，随机分为Cerecyte或裸铂线圈两组。分析的目的是治疗。结果：249例患者使用Cerecyte线圈，251例患者使用裸铂线圈。平衡基线特征。对于动脉瘤破裂，Cerecyte组的住院死亡率为2/114(1.8%)，裸铂线圈组为0/119（0%）。有8例（3.4%）不良程序性事件导致神经功能恶化：Cerecyte组5/114(4.4%)，裸铂线圈组3/119 (2.5%)（P = 0.22）。Cerecyte组6个月mRS评分（3分或死亡）为6/109(5.5%)，裸铂线圈组为2/112 (1.8%)（P = 0.0701）。对于UlAs，没有住院死亡率。伴有神经功能恶化的程序性不良事件7例（2.7%），Cerecyte组5/133例（3.8%），裸铂线圈组2/131例（1.5%）（P = 0.13）。Cerecyte组5/119（4.2%）患者的6个月mRS评分为3分，1例死亡，裸铂线圈组0/123（0%）患者的6个月mRS评分为3分（P = 0.011）。结论：动脉瘤破裂组和未破裂组在出院时和随访6个月时，脑神经细胞组的不良预后有统计学上的差异。两组的总体不良临床结果和住院死亡率都非常低。
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 = 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 = 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.