管道栓塞装置超说明书使用的安全性和有效性概况：一项系统评价和荟萃分析
Safety and efficacy profile of off-label use of the Pipeline Embolization Device: A systematic review and meta-analysis.
作者信息
Senol Yigit Can, Orscelik Atakan, Bilgin Cem, Kobeissi Hassan, Ghozy Sherief, Arul Santhosh, Kallmes David F, Kadirvel Ramanathan
机构信息
Department of Neurologic Surgery, Mayo Clinic, Rochester, MN, USA.
Department of Neurosurgery, Medical University of South Carolina, SC, USA.
出版信息
J Stroke Cerebrovasc Dis. 2024 Apr;33(4):107586. doi: 10.1016/j.jstrokecerebrovasdis.2024.107586. Epub 2024 Jan 17.
OBJECTIVE
The off-label utilization of the Pipeline Embolization Device (PED) is a common practice in numerous medical centers globally. Therefore, we conducted a systematic review and meta-analysis to evaluate the overall outcomes of this off-label usage of PEDs.
METHODS
PubMed, Web of Science, Ovid Medline, Ovid Embase, and Scopus were searched up to February 2023 using the Nested Knowledge platform to identify studies assessing the off-label use of PEDs. Any use of PED outside of the FDA-approved indication granted in 2018 is considered off-label use. Overall angiographic occlusion rates, ischemic and hemorrhagic complications, mortality, retreatment rates, and favorable clinic outcomes were included. Statistical analyses were performed to compare the overall outcome rates of anterior cerebral artery(ACA) vs. middle cerebral artery(MCA) and anterior vs posterior circulation subgroups.
RESULTS
We included 26 studies involving a total of 1,408 patients. The overall rate of complete occlusion was 80.3 % (95 % CI= 76.0-84.1). Subgroup analysis demonstrated a statistically significant difference in the rate of complete occlusion between anterior circulation (78.9 %) and posterior circulation (69.2 %) (p value=0.02). The rate of good clinical outcomes was 92.8 % (95 % CI= 88.8-95.4). The mortality rate was 1.4 % (95 % CI= 0.5-2.7). The overall rate of ischemic complications was 9.5 % (95 % CI= 7.7-11.6), with a comparable difference between anterior circulation (7.7 %) and posterior circulation (12.8 %) (p value=0.07). There was no statistically significant difference in MCA vs ACA subgroups in all parameters.
CONCLUSIONS
Off-label use of PEDs can be a safe and effective treatment option for intracranial aneurysms. However, there is a need for more prospective, high-quality, non-industry-funded registry studies and randomized trials to test the efficacy and safety of off-label usage of PEDs and to expand its indications.
目的
管道栓塞装置（PED）的超说明书使用在全球众多医疗中心是一种常见做法。因此，我们进行了一项系统评价和荟萃分析，以评估PED这种超说明书使用的总体结果。
方法
截至2023年2月，使用嵌套知识平台检索了PubMed、科学网、Ovid Medline、Ovid Embase和Scopus，以识别评估PED超说明书使用的研究。2018年FDA批准适应症以外的PED任何使用都被视为超说明书使用。纳入总体血管造影闭塞率、缺血性和出血性并发症、死亡率、再治疗率以及良好的临床结果。进行统计分析以比较大脑前动脉（ACA）与大脑中动脉（MCA）以及前循环与后循环亚组的总体结果率。
结果
我们纳入了26项研究，共1408例患者。完全闭塞的总体率为80.3%（95%CI = 76.0 - 84.1）。亚组分析显示前循环（78.9%）和后循环（69.2%）之间的完全闭塞率存在统计学显著差异（p值 = 0.02）。良好临床结果的发生率为92.8%（95%CI = 88.8 - 95.4）。死亡率为1.4%（95%CI = 0.5 - 2.7）。缺血性并发症的总体率为9.5%（95%CI = 7.7 - 11. .6），前循环（7.7%）和后循环（12.8%）之间的差异相当（p值 = 0.07）。在所有参数方面，MCA与ACA亚组之间没有统计学显著差异。
结论
PED的超说明书使用可能是颅内动脉瘤的一种安全有效的治疗选择。然而，需要更多前瞻性、高质量、非行业资助的注册研究和随机试验来测试PED超说明书使用的疗效和安全性，并扩大其适应症。
Zotero 插件