欧洲大脑动脉瘤多中心Onyx（CAMEO）试验：在20个欧洲中心进行的前瞻性观察性研究结果
Cerebral Aneurysm Multicenter European Onyx (CAMEO) trial: results of a prospective observational study in 20 European centers.
作者信息
Molyneux Andrew J, Cekirge Saruhan, Saatci Isil, Gál Gyula
机构信息
Neurovascular Research Unit, Radcliffe Infirmary, Oxford, UK.
出版信息
AJNR Am J Neuroradiol. 2004 Jan;25(1):39-51.
BACKGROUND AND PURPOSE
This study was designed to investigate the safety and efficacy of the Onyx liquid embolic system in treating a selected population of patients with intracranial aneurysms that presented difficulties for surgical or endovascular alternatives.
METHODS
A prospective observational study was conducted in 20 European centers enrolling a consecutive series of 119 patients with 123 aneurysms judged suitable for Onyx treatment. The series consists of findings collected in 97 of 119 patients with 100 of 123 aneurysms, because one center declined to provide data to the study sponsor or allow outside audit. Clinical and angiographic outcomes were recorded at discharge, 3 months, and 12 months. All adverse events and re-treatments were recorded. Seventy-nine aneurysms were large or giant.
RESULTS
Twelve-month follow-up angiography findings were available for 71 aneurysms. This angiographic follow-up showed complete occlusion in 56 (79%) aneurysms, subtotal occlusion in nine (13%), and incomplete occlusion in six (8%). Procedure- or device-related permanent neurologic morbidity at final follow-up was present in eight of 97 patients. Seven patients died: two deaths were procedure related; one, disease related; and four, unrelated causes. Seventy-five of the 82 patients alive and with follow-up at 12 months were at Rankin 2 or better status. Delayed occlusion of the parent vessel occurred in nine patients; delayed occlusion was asymptomatic in five and resulted in permanent neurologic deficit in two.
CONCLUSION
In selected patients with aneurysms that are unsuitable for coil treatment or in whom previous treatment has failed to occlude the aneurysm, Onyx treatment offers an endovascular alternative. Aneurysm occlusion rates are superior to reported rates of coil occlusion, and treatment morbidity is comparable to that of published prospective data on endovascular results for this subgroup of patients.
背景与目的
本研究旨在调查Onyx液体栓塞系统治疗特定颅内动脉瘤患者群体的安全性和有效性，这些患者的动脉瘤在手术或血管内治疗方面存在困难。
方法
在20个欧洲中心进行了一项前瞻性观察研究，连续纳入了119例患者的123个动脉瘤，这些动脉瘤被判定适合Onyx治疗。该系列包括119例患者中97例的100个动脉瘤的研究结果，因为有一个中心拒绝向研究主办方提供数据或允许外部审核。记录出院时、3个月和12个月时的临床和血管造影结果。记录所有不良事件和再次治疗情况。79个动脉瘤为大型或巨大型。
结果
71个动脉瘤有12个月的随访血管造影结果。该血管造影随访显示，56个（79%）动脉瘤完全闭塞，9个（13%）次全闭塞，6个（8%）不完全闭塞。在97例患者中，最终随访时出现与手术或器械相关的永久性神经功能障碍的有8例。7例患者死亡：2例死亡与手术相关；1例与疾病相关；4例与其他原因相关。82例存活且有12个月随访的患者中，75例的Rankin评分处于2级或更好状态。9例患者出现母血管延迟闭塞；5例延迟闭塞无症状，2例导致永久性神经功能缺损。
结论
对于动脉瘤不适合进行弹簧圈治疗或先前治疗未能闭塞动脉瘤的特定患者，Onyx治疗提供了一种血管内治疗选择。动脉瘤闭塞率优于报道的弹簧圈闭塞率，治疗并发症发生率与该亚组患者已发表的血管内治疗前瞻性数据相当。
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