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.

中文翻译：

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管道栓塞装置标签外使用的安全性和有效性概况：系统评价和荟萃分析

客观的

管道栓塞装置 (PED) 的标签外使用是全球众多医疗中心的常见做法。因此，我们进行了系统回顾和荟萃分析，以评估这种超说明书使用 PED 的总体结果。

方法

使用 Nested Knowledge 平台对 PubMed、Web of Science、Ovid Medline、Ovid Embase 和 Scopus 进行了截至 2023 年 2 月的检索，以确定评估 PED 标签外使用的研究。在 2018 年 FDA 批准的适应症之外任何 PED 的使用都被视为标签外使用。包括总体血管造影闭塞率、缺血性和出血性并发症、死亡率、再治疗率和良好的临床结果。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，总共涉及 1,408 名患者。完全闭塞的总体率为 80.3% (95% CI= 76.0–84.1)。亚组分析表明，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着差异（p值=0.02）。良好临床结果率为 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发生率为 9.5% (95% CI= 7.7–11.6)，前循环 (7.7%) 和后循环 (12.8%) 之间具有可比性差异 ( p 值=0.07 )。MCA 与 ACA 亚组的所有参数均无统计学显着差异。

结论

超说明书使用 PED 可能是颅内动脉瘤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 超说明书使用的有效性和安全性并扩大其适应症。