Department of Surgery, University Hospital Prof. Alberto Antunes (Federal University of Alagoas), Maceio, Brazil.
Emergency Medicine and Evidence Based Medicine, Universidade Federal de São Paulo, São Paulo, Brazil.
Cochrane Database Syst Rev. 2021 May 10;5(5):CD013312. doi: 10.1002/14651858.CD013312.pub2.
Unruptured intracranial aneurysms are relatively common lesions in the general population, with a prevalence of 3.2%, and are being diagnosed with greater frequency as non-invasive techniques for imaging of intracranial vessels have become increasingly available and used. If not treated, an intracranial aneurysm can be catastrophic. Morbidity and mortality in aneurysmal subarachnoid hemorrhage are substantial: in people with subarachnoid hemorrhage, 12% die immediately, more than 30% die within one month, 25% to 50% die within six months, and 30% of survivors remain dependent. However, most intracranial aneurysms do not bleed, and the best treatment approach is still a matter of debate.
To assess the risks and benefits of interventions for people with unruptured intracranial aneurysms.
We searched CENTRAL (Cochrane Library 2020, Issue 5), MEDLINE Ovid, Embase Ovid, and Latin American and Caribbean Health Science Information database (LILACS). We also searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform from inception to 25 May 2020. There were no language restrictions. We contacted experts in the field to identify further studies and unpublished trials.
Unconfounded, truly randomized trials comparing conservative treatment versus interventional treatments (microsurgical clipping or endovascular coiling) and microsurgical clipping versus endovascular coiling for individuals with unruptured intracranial aneurysms.
Two review authors independently selected trials for inclusion according to the above criteria, assessed trial quality and risk of bias, performed data extraction, and applied the GRADE approach to the evidence. We used an intention-to-treat analysis strategy.
We included two trials in the review: one prospective randomized trial involving 80 participants that compared conservative treatment to endovascular coiling, and one randomized controlled trial involving 136 participants that compared microsurgical clipping to endovascular coiling for unruptured intracranial aneurysms. There was no difference in outcome events between conservative treatment and endovascular coiling groups. New perioperative neurological deficits were more common in participants treated surgically (16/65, 24.6%; 15.8% to 36.3%) versus 7/69 (10.1%; 5.0% to 19.5%); odds ratio (OR) 2.87 (95% confidence interval (CI) 1.02 to 8.93; P = 0.038). Hospitalization for more than five days was more common in surgical participants (30/65, 46.2%; 34.6% to 58.1%) versus 6/69 (8.7%; 4.0% to 17.7%); OR 8.85 (95% CI 3.22 to 28.59; P < 0.001). Clinical follow-up to one year showed 1/48 clipped versus 1/58 coiled participants had died, and 1/48 clipped versus 1/58 coiled participants had become disabled (modified Rankin Scale > 2). All the evidence is of very low quality.
AUTHORS' CONCLUSIONS: There is currently insufficient good-quality evidence to support either conservative treatment or interventional treatments (microsurgical clipping or endovascular coiling) for individuals with unruptured intracranial aneurysms. Further randomized trials are required to establish if surgery is a better option than conservative management, and if so, which surgical approach is preferred for which patients. Future studies should include consideration of important characteristics such as participant age, gender, aneurysm size, aneurysm location (anterior circulation and posterior circulation), grade of ischemia (major stroke), and duration of hospitalizations.
未破裂颅内动脉瘤在普通人群中较为常见,患病率为 3.2%,随着用于颅内血管成像的无创技术越来越普及和应用,其诊断率也越来越高。如果不加以治疗,颅内动脉瘤可能会带来灾难性的后果。蛛网膜下腔出血所致的颅内动脉瘤患者的发病率和死亡率很高:蛛网膜下腔出血患者中,12%的人会立即死亡,超过 30%的人在一个月内死亡,25%至 50%的人在六个月内死亡,30%的幸存者仍然依赖他人。然而,大多数颅内动脉瘤不会破裂出血,最佳的治疗方法仍存在争议。
评估未破裂颅内动脉瘤患者接受干预治疗的风险和获益。
我们检索了 Cochrane 图书馆 2020 年第 5 期、Ovid 版 MEDLINE、Ovid 版 Embase 和拉丁美洲及加勒比健康科学信息数据库(LILACS)。我们还检索了 ClinicalTrials.gov 和世界卫生组织国际临床试验注册平台,检索时间截至 2020 年 5 月 25 日。我们没有设置语言限制。我们联系了该领域的专家,以确定其他研究和未发表的试验。
真正的、未混杂的随机试验,比较保守治疗与介入治疗(显微夹闭或血管内介入治疗),以及显微夹闭与血管内介入治疗对未破裂颅内动脉瘤患者的效果。
两位综述作者根据上述标准独立选择试验进行纳入,评估试验质量和偏倚风险,进行数据提取,并使用 GRADE 方法评估证据。我们采用意向治疗分析策略。
我们纳入了两项试验:一项前瞻性随机试验纳入了 80 名参与者,比较了保守治疗与血管内介入治疗;另一项随机对照试验纳入了 136 名参与者,比较了显微夹闭与血管内介入治疗对未破裂颅内动脉瘤的效果。保守治疗组与血管内介入治疗组之间的结局事件无差异。手术治疗组新发生围手术期神经功能缺损更为常见(16/65,24.6%;5.0%至 19.5%),而 6/69 名(10.1%;5.0%至 19.5%);比值比(OR)2.87(95%置信区间(CI)1.02 至 8.93;P = 0.038)。手术治疗组住院时间超过 5 天更为常见(30/65,46.2%;34.6%至 58.1%),而 6/69 名(8.7%;4.0%至 17.7%);OR 8.85(95% CI 3.22 至 28.59;P < 0.001)。在为期一年的临床随访中,48 名夹闭的参与者中有 1 名死亡,58 名接受血管内介入治疗的参与者中有 1 名残疾(改良 Rankin 量表评分>2)。所有证据质量均为极低质量。
目前尚无足够高质量的证据支持对未破裂颅内动脉瘤患者进行保守治疗或介入治疗(显微夹闭或血管内介入治疗)。需要进一步开展随机试验,以确定手术是否优于保守治疗,以及在何种情况下手术是更好的选择,以及哪种手术方法更适合哪些患者。未来的研究应考虑参与者的年龄、性别、动脉瘤大小、动脉瘤位置(前循环和后循环)、缺血程度(大卒中等)和住院时间等重要特征。