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血管内栓塞术与神经外科夹闭术治疗动脉瘤性蛛网膜下腔出血患者的比较。

Endovascular coiling versus neurosurgical clipping for people with aneurysmal subarachnoid haemorrhage.

作者信息

Lindgren Antti, Vergouwen Mervyn DI, van der Schaaf Irene, Algra Ale, Wermer Marieke, Clarke Mike J, Rinkel Gabriel Je

机构信息

Department of Neurosurgery, Kuopio University Hospital, Puijonlaaksontie 2, Kuopio, Kuopio, Finland, 70029.

出版信息

Cochrane Database Syst Rev. 2018 Aug 15;8(8):CD003085. doi: 10.1002/14651858.CD003085.pub3.

Abstract

BACKGROUND

Around 30% of people who are admitted to hospital with aneurysmal subarachnoid haemorrhage (SAH) will rebleed in the initial month after the haemorrhage if the aneurysm is not treated. The two most commonly used methods to occlude the aneurysm for prevention of rebleeding are microsurgical clipping of the neck of the aneurysm and occlusion of the lumen of the aneurysm by means of endovascular coiling. This is an update of a systematic review that was previously published in 2005.

OBJECTIVES

To compare the effects of endovascular coiling versus neurosurgical clipping in people with aneurysmal SAH on poor outcome, rebleeding, neurological deficit, and treatment complications.

SEARCH METHODS

We searched the Cochrane Stroke Group Trials Register (March 2018). In addition, we searched CENTRAL (2018, Issue 2), MEDLINE (1966 to March 2018), Embase (1980 to March 2018), US National Institutes of Health Ongoing Trials Register (March 2018), and World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (last searched March 2018). We also contacted trialists.

SELECTION CRITERIA

We included randomised trials comparing endovascular coiling with neurosurgical clipping in people with SAH from a ruptured aneurysm.

DATA COLLECTION AND ANALYSIS

Two review authors independently extracted data, and assessed trial quality and risk of bias using the GRADE approach. We contacted trialists to obtain missing information. We defined poor outcome as death or dependence in daily activities (modified Rankin scale 3 to 6 or Glasgow Outcome Scale (GOS) 1 to 3). In the special worst-case scenario analysis, we assumed all participants in the group with better outcome with missing follow-up information had a poor outcome and those in the other group with missing data a good outcome.

MAIN RESULTS

We included four randomised trials involving 2458 participants (range per trial: 20 to 2143 participants). Evidence is mostly based on the largest trial. Most participants were in good clinical condition and had an aneurysm on the anterior circulation. None of the included trials was at low risk of bias in all domains. One trial was at unclear risk in one domain, two trials at unclear risk in three domains, and one trial at high risk in one domain.After one year of follow-up, 24% of participants randomised to endovascular treatment and 32% of participants randomised to the surgical treatment group had poor functional outcome. The risk ratio (RR) of poor outcome (death or dependency) for endovascular coiling versus neurosurgical clipping was 0.77 (95% confidence interval (CI) 0.67 to 0.87; 4 trials, 2429 participants, moderate-quality evidence), and the absolute risk reduction was 7% (95% CI 4% to 11%). In the worst-case scenario analysis for poor outcome, the RR for endovascular coiling versus neurosurgical clipping was 0.80 (95% CI 0.71 to 0.91), and the absolute risk reduction was 6% (95% CI 2% to 10%). The RR of death at 12 months was 0.80 (95% CI 0.63 to 1.02; 4 trials, 2429 participants, moderate-quality evidence). In a subgroup analysis of participants with an anterior circulation aneurysm, the RR of poor outcome was 0.78 (95% CI 0.68 to 0.90; 2 trials, 2157 participants, moderate-quality evidence), and the absolute risk decrease was 7% (95% CI 3% to 10%). In subgroup analysis of those with a posterior circulation aneurysm, the RR was 0.41 (95% CI 0.19 to 0.92; 2 trials, 69 participants, low-quality evidence), and the absolute decrease in risk was 27% (95% CI 6% to 48%). At five years, 28% of participants randomised to endovascular treatment and 32% of participants randomised to surgical treatment had poor functional outcome. The RR of poor outcome for endovascular coiling versus neurosurgical clipping was 0.87 (95% CI 0.75 to 1.01, 1 trial, 1724 participants, low-quality evidence). At 10 years, 35% participants allocated to endovascular and 43% participants allocated to surgical treatment had poor functional outcome. At 10 years RR of poor outcome for endovascular coiling versus neurosurgical clipping was 0.81 (95% CI 0.70 to 0.92; 1 trial, 1316 participants, low-quality evidence). The RR of delayed cerebral ischaemia at two to three months for endovascular coiling versus neurosurgical clipping was 0.84 (95% CI 0.74 to 0.96; 4 trials, 2450 participants, moderate-quality evidence). The RR of rebleeding for endovascular coiling versus neurosurgical clipping was 1.83 (95% CI 1.04 to 3.23; 4 trials, 2458 participants, high-quality evidence) at one year, and 2.69 (95% CI 1.50 to 4.81; 1 trial, 1323 participants, low-quality evidence) at 10 years. The RR of complications from intervention for endovascular coiling versus neurosurgical clipping was 1.05 (95% CI 0.44 to 2.53; 2 trials, 129 participants, low-quality evidence).

AUTHORS' CONCLUSIONS: The evidence in this systematic review comes mainly from one large trial, and long-term follow-up is available only for a subgroup of participants within that trial. For people in good clinical condition with ruptured aneurysms of either the anterior or posterior circulation the data from randomised trials show that, if the aneurysm is considered suitable for both neurosurgical clipping and endovascular coiling, coiling is associated with a better outcome. There is no reliable trial evidence that can be used directly to guide treatment in people with a poor clinical condition.

摘要

背景

约30%因动脉瘤性蛛网膜下腔出血(SAH)入院的患者,若动脉瘤未得到治疗,将在出血后的最初一个月内再次出血。预防再次出血最常用的两种闭塞动脉瘤的方法是对动脉瘤颈部进行显微手术夹闭和通过血管内栓塞闭塞动脉瘤腔。这是对先前于2005年发表的一项系统评价的更新。

目的

比较血管内栓塞与神经外科夹闭对动脉瘤性SAH患者不良结局、再出血、神经功能缺损及治疗并发症的影响。

检索方法

我们检索了Cochrane卒中小组试验注册库(2018年3月)。此外,我们还检索了Cochrane系统评价数据库(CENTRAL,2018年第2期)、医学期刊数据库(MEDLINE,1966年至2018年3月)、荷兰医学文摘数据库(Embase,1980年至2018年3月)、美国国立卫生研究院正在进行的试验注册库(2018年3月)以及世界卫生组织(WHO)国际临床试验注册平台(ICTRP)(最后检索时间为2018年3月)。我们还联系了试验研究者。

入选标准

我们纳入了比较血管内栓塞与神经外科夹闭治疗破裂动脉瘤所致SAH患者的随机试验。

数据收集与分析

两位综述作者独立提取数据,并使用GRADE方法评估试验质量和偏倚风险。我们联系试验研究者以获取缺失信息。我们将不良结局定义为死亡或日常生活依赖(改良Rankin量表评分为3至6分或格拉斯哥结局量表(GOS)评分为1至3分)。在特殊的最坏情况分析中,我们假设随访信息缺失但结局较好组的所有参与者结局不良,而另一组数据缺失者结局良好。

主要结果

我们纳入了四项随机试验,涉及2458名参与者(每项试验的范围:20至2143名参与者)。证据主要基于最大的试验。大多数参与者临床状况良好,动脉瘤位于前循环。纳入的试验在所有领域均不存在低偏倚风险。一项试验在一个领域的偏倚风险不明确,两项试验在三个领域的偏倚风险不明确,一项试验在一个领域存在高偏倚风险。随访一年后,随机接受血管内治疗的参与者中有24%以及随机接受手术治疗组的参与者中有32%出现不良功能结局。血管内栓塞与神经外科夹闭相比,不良结局(死亡或依赖)的风险比(RR)为0.77(95%置信区间(CI)0.67至0.87;4项试验,2429名参与者,中等质量证据),绝对风险降低7%(95%CI 4%至11%)。在不良结局的最坏情况分析中,血管内栓塞与神经外科夹闭相比的RR为0.80(95%CI 0.71至0.91),绝对风险降低6%(95%CI 2%至10%)。12个月时的死亡RR为0.80(95%CI 0.63至1.02;4项试验,2429名参与者,中等质量证据)。在前循环动脉瘤参与者的亚组分析中,不良结局的RR为0.78(95%CI 0.68至0.90;2项试验,2157名参与者,中等质量证据),绝对风险降低7%(95%CI 3%至10%)。在后循环动脉瘤参与者的亚组分析中,RR为0.41(95%CI 0.19至0.92;2项试验,69名参与者,低质量证据),风险绝对降低27%(95%CI 6%至48%)。五年时,随机接受血管内治疗的参与者中有28%以及随机接受手术治疗的参与者中有32%出现不良功能结局。血管内栓塞与神经外科夹闭相比,不良结局的RR为0.87(95%CI 0.75至1.01,1项试验,1724名参与者,低质量证据)。十年时,分配接受血管内治疗的参与者中有35%以及分配接受手术治疗的参与者中有43%出现不良功能结局。十年时,血管内栓塞与神经外科夹闭相比,不良结局的RR为0.81(95%CI 0.70至0.92;1项试验,1316名参与者,低质量证据)。血管内栓塞与神经外科夹闭相比,两至三个月时延迟性脑缺血的RR为0.84(95%CI 0.74至0.96;4项试验,2450名参与者,中等质量证据)。血管内栓塞与神经外科夹闭相比,一年时再出血的RR为1.83(95%CI 1.04至3.23;4项试验,2458名参与者,高质量证据),十年时为2.69(95%CI 1.50至4.81;1项试验,1323名参与者,低质量证据)。血管内栓塞与神经外科夹闭相比,干预并发症的RR为1.05(95%CI 0.44至2.53;2项试验,129名参与者,低质量证据)。

作者结论

本系统评价中的证据主要来自一项大型试验,且仅对该试验中的部分参与者进行了长期随访。对于前循环或后循环破裂动脉瘤且临床状况良好的患者,随机试验数据表明,如果动脉瘤被认为适合神经外科夹闭和血管内栓塞两种治疗方法,栓塞的结局更好。没有可靠的试验证据可直接用于指导临床状况较差患者的治疗。

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