Wenz Fabian, Wiedemann Tamara, Rinkel Gabriel Je, Etminan Nima
Department of Neurosurgery, University Hospital Mannheim, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
Eur Stroke J. 2025 Sep 9:23969873251370992. doi: 10.1177/23969873251370992.
Flow-diverting (FD) stents are increasingly used to treat small, unruptured intracranial aneurysms (UIA), but high-quality, unbiased data on initial complications and clinical outcomes were limited in previous literature reviews. We updated the literature review to assess quality, potential bias, complications and short-term outcomes in studies on FD-stents for UIAs.
We systematically searched PubMed, Embase and Cochrane Library until January 9, 2025 for studies on FD-stents for UIAs. We assessed methodological quality using the methodological index for non-randomised studies (poor: 0-9, moderate: 10-13, good: 14-16), and financial conflicts of interest. The primary outcome was neurological outcome according to a validated outcome scale at 1-3 months after treatment. Secondary outcomes were clinical worsening and complications.
We included 13 studies with 743 patients and 806 UIAs, of which 88.4% (95% CI: 85.7%-91.2%) were <10 mm. All studies were uncontrolled. The methodological quality was poor in six and moderate in seven studies. Financial conflicts of interest were reported in six studies. At 1-3 months after treatment, the proportion of patients were for mRS ⩾1 13.3% (95% CI: 10.0%-16.6%), mRS ⩾2 5.3% (95% CI: 3.2%-7.5%), mRS ⩾3 2.4% (95% CI: 0.1%-3.9%) and neurological worsening 3.1% (95% CI: 1.5%-4.6%). Complications within 3 months occurred in 12.7% (95% CI: 10.3%-15.0%).
The literature on FD-stents is methodologically weak and potentially biased by financial interests but still shows relevant proportions of complications and post-treatment morbidity. Currently, there are no good data supporting the use of FD-stents for UIAs where standard treatment options are available. Randomised-controlled trials are needed to compare safety, efficacy and durability between FD-stents and coiling or clipping.
血流导向（FD）支架越来越多地用于治疗小型未破裂颅内动脉瘤（UIA），但在以往的文献综述中，关于初始并发症和临床结局的高质量、无偏倚数据有限。我们更新了文献综述，以评估FD支架治疗UIA的研究中的质量、潜在偏倚、并发症和短期结局。
我们系统检索了PubMed、Embase和Cochrane图书馆，直至2025年1月9日，以查找关于FD支架治疗UIA的研究。我们使用非随机研究的方法学指数（差：0-9，中等：10-13，好：14-16）和财务利益冲突来评估方法学质量。主要结局是治疗后1-3个月根据经过验证的结局量表得出的神经学结局。次要结局是临床恶化和并发症。
我们纳入了13项研究，共743例患者和806个UIA，其中88.4%（95%CI：85.7%-91.2%）小于10mm。所有研究均为非对照研究。6项研究的方法学质量差，7项研究为中等。6项研究报告了财务利益冲突。治疗后1-3个月，改良Rankin量表（mRS）评分≥1的患者比例为13.3%（95%CI：10.0%-16.6%），mRS评分≥2的患者比例为5.3%（95%CI：3.2%-7.5%），mRS评分≥3的患者比例为2.4%（95%CI：0.1%-3.9%），神经功能恶化的患者比例为3.1%（95%CI：1.5%-4.6%）。3个月内并发症的发生率为12.7%（95%CI：10.3%-15.0%）。
关于FD支架的文献在方法学上存在缺陷，可能受到财务利益的影响，但仍显示出一定比例的并发症和治疗后发病率。目前，没有良好的数据支持在有标准治疗选择的情况下使用FD支架治疗UIA。需要进行随机对照试验来比较FD支架与弹簧圈栓塞或夹闭术在安全性、有效性和耐久性方面的差异。
