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      Endovascular coiling versus neurosurgical clipping for people with aneurysmal subarachnoid haemorrhage

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          Abstract

          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. To compare the effects of endovascular coiling versus neurosurgical clipping in people with aneurysmal SAH on poor outcome, rebleeding, neurological deficit, and treatment complications. 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. We included randomised trials comparing endovascular coiling with neurosurgical clipping in people with SAH from a ruptured aneurysm. 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. 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). 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. Endovascular coiling versus neurosurgical clipping for people with aneurysmal subarachnoid haemorrhage Review question 
 We reviewed the outcome after endovascular coiling compared with neurosurgical clipping after a subarachnoid haemorrhage. Background 
 Bleeding under the surface membrane of the brain is called a subarachnoid haemorrhage. The bleeding usually comes from the rupture of a weak spot in an artery carrying blood to the brain. This weak spot is like a small balloon, which is called an aneurysm. The outcome after subarachnoid haemorrhage from an aneurysm is generally poor: a third of all people die within three months, and one of every five people remains dependent on someone else for help with every day activities such as walking, dressing, bathing, and taking care of one's own affairs. One of the risks in people with subarachnoid haemorrhage is rebleeding. There are two ways to try and prevent this: neurosurgical clipping of the neck of the aneurysm in an operation or blocking the aneurysm from inside by endovascular coiling. Study characteristics 
 In March 2018, we searched for randomised controlled trials (RCTs, clinical studies where people are randomly put into one of two or more treatment groups) comparing endovascular coiling with neurosurgical clipping for subarachnoid haemorrhage. We found one new RCT and additional data for previously identified RCTs, allowing us to include four RCTs involving 2458 participants. Key results 
 The data from RCTs showed that the number of people who survived and were independent in their daily living was higher after endovascular coiling than after neurosurgical clipping, if both treatment options were possible. Risk of rebleeding was higher in people treated with endovascular coiling. The evidence came mainly from one large trial. Quality of the evidence 
 We judged that there is sufficient evidence to guide treatment for people in a relatively good condition whose aneurysm is considered suitable for both neurosurgical clipping and endovascular treatment. There is no reliable trial evidence that can be used directly to guide treatment in people with a poor clinical condition.

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          Most cited references30

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          International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion.

          Two types of treatment are being used for patients with ruptured intracranial aneurysms: endovascular detachable-coil treatment or craniotomy and clipping. We undertook a randomised, multicentre trial to compare these treatments in patients who were suitable for either treatment because the relative safety and efficacy of these approaches had not been established. Here we present clinical outcomes 1 year after treatment. 2143 patients with ruptured intracranial aneurysms, who were admitted to 42 neurosurgical centres, mainly in the UK and Europe, took part in the trial. They were randomly assigned to neurosurgical clipping (n=1070) or endovascular coiling (n=1073). The primary outcome was death or dependence at 1 year (defined by a modified Rankin scale of 3-6). Secondary outcomes included rebleeding from the treated aneurysm and risk of seizures. Long-term follow up continues. Analysis was in accordance with the randomised treatment. We report the 1-year outcomes for 1063 of 1073 patients allocated to endovascular treatment, and 1055 of 1070 patients allocated to neurosurgical treatment. 250 (23.5%) of 1063 patients allocated to endovascular treatment were dead or dependent at 1 year, compared with 326 (30.9%) of 1055 patients allocated to neurosurgery, an absolute risk reduction of 7.4% (95% CI 3.6-11.2, p=0.0001). The early survival advantage was maintained for up to 7 years and was significant (log rank p=0.03). The risk of epilepsy was substantially lower in patients allocated to endovascular treatment, but the risk of late rebleeding was higher. In patients with ruptured intracranial aneurysms suitable for both treatments, endovascular coiling is more likely to result in independent survival at 1 year than neurosurgical clipping; the survival benefit continues for at least 7 years. The risk of late rebleeding is low, but is more common after endovascular coiling than after neurosurgical clipping.
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            Changes in case fatality of aneurysmal subarachnoid haemorrhage over time, according to age, sex, and region: a meta-analysis.

            In a systematic review, published in 1997, we found that the case fatality of aneurysmal subarachnoid haemorrhage (SAH) decreased during the period 1960-95. Because diagnostic and treatment strategies have improved and new studies from previously non-studied regions have been published since 1995, we did an updated meta-analysis to assess changes in case fatality and morbidity and differences according to age, sex, and region. A new search of PubMed with predefined inclusion criteria for case finding and diagnosis identified reports on prospective population-based studies published between January, 1995, and July, 2007. The studies included in the previous systematic review were reassessed with the new inclusion criteria. Changes in case fatality over time and the effect of age and sex were quantified with weighted linear regression. Regional differences were analysed with linear regression analysis, and the regions of interest were subsequently defined as reference regions and compared with the other regions. 33 studies (23 of which were published in 1995 or later) were included that described 39 study periods. These studies reported on 8739 patients, of whom 7659 [88%] were reported on after 1995. 11 of the studies that were included in the previous review did not meet the current, more stringent, inclusion criteria. The mean age of patients had increased in the period 1973 to 2002 from 52 to 62 years. Case fatality varied from 8.3% to 66.7% between studies and decreased 0.8% per year (95% CI 0.2 to 1.3). The decrease was unchanged after adjustment for sex, but the decrease per year was 0.4% (-0.5 to 1.2) after adjustment for age. Case fatality was 11.8% (3.8 to 19.9) lower in Japan than it was in Europe, the USA, Australia, and New Zealand. The unadjusted decrease in case fatality excluding the data for Japan was 0.6% per year (0.0 to 1.1), a 17% decrease over the three decades. Six studies reported data on case morbidity, but these were insufficient to assess changes over time. Despite an increase in the mean age of patients with SAH, case-fatality rates have decreased by 17% between 1973 and 2002 and show potentially important regional differences. This decrease coincides with the introduction of improved management strategies. Netherlands Organisation for Scientific Research; ZonMw.
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              Incidence of subarachnoid haemorrhage: a systematic review with emphasis on region, age, gender and time trends.

              To update our 1996 review on the incidence of subarachnoid haemorrhage (SAH) and assess the relation of incidence with region, age, gender and time period. We searched for studies on the incidence of SAH published until October 2005. The overall incidences with corresponding 95% confidence intervals were calculated. We determined the relationship between the incidence of SAH and determinants by means of univariate Poisson regression. We included 51 studies (33 new), describing 58 study populations in 21 countries, observing 45,821,896 person-years. Incidences per 100,000 person-years were 22.7 (95% CI 21.9 to 23.5) in Japan, 19.7 (18.1 to 21.3) in Finland, 4.2 (3.1 to 5.7) in South and Central America, and 9.1 (8.8 to 9.5) in the other regions. With age category 45-55 years as the reference, incidence ratios increased from 0.10 (0.08 to 0.14) for age groups younger than 25 years to 1.61 (1.24 to 2.07) for age groups older than 85 years. The incidence in women was 1.24 (1.09 to 1.42) times higher than in men; this gender difference started at age 55 years and increased thereafter. Between 1950 and 2005, the incidence decreased by 0.6% (1.3% decrease to 0.1% increase) per year. The overall incidence of SAH is approximately 9 per 100,000 person-years. Rates are higher in Japan and Finland and increase with age. The preponderance of women starts only in the sixth decade. The decline in incidence of SAH over the past 45 years is relatively moderate compared with that for stroke in general.

                Author and article information

                Journal
                Cochrane Database of Systematic Reviews
                Wiley
                14651858
                August 15 2018
                Affiliations
                [1 ]Kuopio University Hospital; Department of Neurosurgery; Puijonlaaksontie 2 Kuopio Kuopio Finland 70029
                [2 ]University Medical Center Utrecht; Department of Neurology and Neurosurgery; PO Box 85500 Utrecht Netherlands 3508 GA
                [3 ]University Medical Center Utrecht; Department of Radiology; Heidelberglaan 100 Utrecht Netherlands 3508 GA
                [4 ]University Medical Center Utrecht; Julius Center for Health Sciences and Primary Care/Department of Neurology and Neurosurgery; PO Box 85500 Utrecht Netherlands 3508 GA
                [5 ]Leiden University Medical Center; Department of Neurology; Albinusdreef 2 Leiden Netherlands 2333 ZA
                [6 ]Queen's University Belfast; Centre for Public Health; Institute of Clinical Sciences, Block B, Royal Victoria Hospital Grosvenor Road Belfast Northern Ireland UK BT12 6BJ
                Article
                10.1002/14651858.CD003085.pub3
                6513627
                30110521
                e3df1e9d-fe8e-4f34-bbdc-cdec5dc1a42a
                © 2018
                History

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