Department of Surgery, Division of Neurosurgery, University of Alberta, Edmonton, Canada.
Service de Neurochirurgie, CHU Cavale Blanche, INSERM UMR 1101 LaTIM, Brest, France.
J Neurol Neurosurg Psychiatry. 2017 Aug;88(8):663-668. doi: 10.1136/jnnp-2016-315433. Epub 2017 Jun 20.
Unruptured intracranial aneurysms (UIAs) are increasingly diagnosed and are commonly treated using endovascular treatment or microsurgical clipping. The safety and efficacy of treatments have not been compared in a randomised trial. How to treat patients with UIAs suitable for both options remains unknown.
We randomly allocated clipping or coiling to patients with one or more 3-25 mm UIAs judged treatable both ways. The primary outcome was treatment failure, defined as: initial failure of aneurysm treatment, intracranial haemorrhage or residual aneurysm on 1-year imaging. Secondary outcomes included neurological deficits following treatment, hospitalisation >5 days, overall morbidity and mortality and angiographic results at 1 year.
The trial was designed to include 260 patients. An analysis was performed for slow accrual: 136 patients were enrolled from 2010 through 2016 and 134 patients were treated. The 1-year primary outcome, available for 104 patients, was reached in 5/48 (10.4% (4.5%-22.2%)) patients allocated surgical clipping, and 10/56 (17.9% (10.0%-29.8%)) patients allocated endovascular coiling (OR: 0.54 (0.13-1.90), p=0.40). Morbidity and mortality (modified Rankin Scale>2) at 1 year occurred in 2/48 (4.2% (1.2%-14.0%)) and 2/56 (3.6% (1.0%-12.1%)) patients allocated clipping and coiling, respectively. New neurological deficits (15/65 vs 6/69; OR: 3.12 (1.05-10.57), p=0.031), and hospitalisations beyond 5 days (30/65 vs 6/69; OR: 8.85 (3.22-28.59), p=0.0001) were more frequent after clipping.
Surgical clipping or endovascular coiling of UIAs did not show differences in morbidity at 1 year. Trial continuation and additional randomised evidence will be necessary to establish the supposed superior efficacy of clipping.
未破裂颅内动脉瘤（UIAs）的诊断率逐渐增高，通常采用血管内治疗或显微手术夹闭进行治疗。两种治疗方法的安全性和有效性尚未在随机试验中进行比较。对于适合两种治疗方法的 UIAs 患者，如何进行治疗仍不清楚。
我们将夹闭或血管内栓塞随机分配给经评估适合两种治疗方法的单发或多发 3-25mm 的 UIAs 患者。主要结局为治疗失败，定义为：动脉瘤治疗初始失败、颅内出血或 1 年影像学检查时仍有残余动脉瘤。次要结局包括治疗后神经功能缺损、住院时间＞5 天、总发病率和死亡率以及 1 年时的血管造影结果。
该试验设计纳入 260 例患者。由于入组缓慢，我们进行了亚组分析：2010 年至 2016 年期间纳入了 136 例患者，其中 134 例患者接受了治疗。104 例患者可获得 1 年主要结局，手术夹闭组 5 例（10.4%（4.5%-22.2%））和血管内栓塞组 10 例（17.9%（10.0%-29.8%））达到治疗失败，夹闭组和栓塞组的 1 年比值比（OR）分别为 0.54（0.13-1.90）和 0.40。夹闭组和栓塞组 1 年时的发病率和死亡率（改良 Rankin 量表＞2）分别为 2/48（4.2%（1.2%-14.0%））和 2/56（3.6%（1.0%-12.1%））。夹闭组新发神经功能缺损（15/65 例 vs 6/69 例；OR：3.12（1.05-10.57），p=0.031）和住院时间＞5 天（30/65 例 vs 6/69 例；OR：8.85（3.22-28.59），p=0.0001）的发生率高于栓塞组。
血管内栓塞和显微手术夹闭治疗 UIAs 在 1 年时的发病率无差异。需要继续进行试验和额外的随机证据，以确定夹闭术的优势疗效。
