Li Wei, Xiao Zaixing, Zhao Kaixuan, Yang Shijie, Zhang Yichuan, Li Bin, Zhou Yu, Ma Yong, Chai Erqing
The First Clinical Medical College of Gansu University of Chinese Medicine, Lanzhou, China.
Cerebrovascular Disease Center of Gansu Provincial People's Hospital, Lanzhou, China.
Front Neurol. 2022 Sep 29;13:978602. doi: 10.3389/fneur.2022.978602. eCollection 2022.
In recent years, the Pipeline embolization device (PED) has been widely used in the embolization of intracranial aneurysms, but there are some inconsistent findings on whether its efficacy and safety are superior to those of traditional coils embolization (coils alone, stent-assisted coils and balloon-assisted coils). The purpose of this meta-analysis was to evaluate the safety and efficacy of PED in intracranial aneurysm embolization by comparing with traditional coils.
We systematically searched PubMed, Embase, Web of Science, and The Cochrane Library databases for randomized controlled trials and observational studies (case-control studies and cohort studies) comparing the efficacy of PED with traditional coils in intracranial aneurysm embolization published before April 1, 2022. The endpoints observed in this meta-analysis were procedure-related intracranial hemorrhage, procedure-related intracranial ischemia, other procedure-related complications (e.g., aneurysm rupture, neurological impairment, etc.), retreatment rate, complete occlusion (100%) of the aneurysm at the last follow-up, and favorable functional outcome (MRS ≤ 2).
A total of 10 studies with a total of 1,400 patients (PED group: 576 and Traditional coils: 824) were included in this meta-analysis. A comprehensive analysis of the included literature showed that the PED group had a higher rate of complete aneurysm occlusion [OR = 2.62, 95% Cl (1.94, 3.55), < 0.00001] and Lower re-treatment rate [OR = 0.20, 95% Cl (0.12, 0.34 < 0.00001)] compared with the traditional coil embolization group at the last follow-up. In terms of procedure-related intracranial hemorrhage [OR = 3.04, 95% Cl (1.08, 8.57), = 0.04] and other procedure-related complications [OR = 2.91, 95% Cl (1.48, 5.57), = 0.002], the incidence of PED was higher than that of the traditional coil embolization group. Moreover, in terms of favorable functional outcome [OR = 0.4, 95% Cl (0.22, 0.71), = 0.002] of patients at the last follow-up, the PED group was lower than the traditional coil embolization group. There was no statistically significant between the two groups in terms of surgery-related intracranial ischemia complications [OR = 0.88, 95% Cl (0.47, 1.64), = 0.68].
PED had higher rates of complete aneurysm occlusion and lower rates of aneurysm retreatment compared with traditional coils, but traditional coils was superior to the PED group in terms of procedure-related intracranial hemorrhage complication and other procedure-related complications (aneurysm rupture, neurological impairment), and favorable functional outcome (mRS ≤ 2). This result still needs to be further confirmed by additional large-sample, multicenter, prospective randomized controlled trials.
https://www.crd.york.ac.uk/PROSPERO/, identifier: CRD42022325673.
近年来，管道栓塞装置（PED）已广泛应用于颅内动脉瘤的栓塞治疗，但关于其疗效和安全性是否优于传统弹簧圈栓塞（单纯弹簧圈、支架辅助弹簧圈和球囊辅助弹簧圈）存在一些不一致的研究结果。本荟萃分析的目的是通过与传统弹簧圈比较，评估PED在颅内动脉瘤栓塞治疗中的安全性和疗效。
我们系统检索了PubMed、Embase、Web of Science和Cochrane图书馆数据库，以查找2022年4月1日前发表的比较PED与传统弹簧圈在颅内动脉瘤栓塞治疗中疗效的随机对照试验和观察性研究（病例对照研究和队列研究）。本荟萃分析中观察的终点包括与手术相关的颅内出血、与手术相关的颅内缺血、其他与手术相关的并发症（如动脉瘤破裂、神经功能损害等）、再次治疗率、最后一次随访时动脉瘤完全闭塞（100%）以及良好的功能结局（改良Rankin量表评分≤2）。
本荟萃分析共纳入10项研究，总计1400例患者（PED组：576例，传统弹簧圈组：824例）。对纳入文献的综合分析表明，与传统弹簧圈栓塞组相比，PED组在最后一次随访时动脉瘤完全闭塞率更高[比值比（OR）=2.62，95%置信区间（Cl）（1.94，3.55），P<0.00001]，再次治疗率更低[OR=0.20，95%Cl（0.12，0.34），P<0.00001]。在与手术相关的颅内出血方面[OR=3.04，95%Cl（1.08，8.57），P=0.04]以及其他与手术相关的并发症方面[OR=2.91，95%Cl（1.48，5.57），P=0.002]，PED的发生率高于传统弹簧圈栓塞组。此外，在最后一次随访时患者良好的功能结局方面[OR=0.4，95%Cl（0.22，0.71），P=0.002]，PED组低于传统弹簧圈栓塞组。两组在与手术相关的颅内缺血并发症方面无统计学差异[OR=0.88，95%Cl（0.47，1.64），P=0.68]。
与传统弹簧圈相比，PED具有更高的动脉瘤完全闭塞率和更低的动脉瘤再次治疗率，但在与手术相关的颅内出血并发症以及其他与手术相关的并发症（动脉瘤破裂、神经功能损害）和良好的功能结局（改良Rankin量表评分≤2）方面，传统弹簧圈优于PED组。这一结果仍需进一步通过更多大样本、多中心、前瞻性随机对照试验来证实。
