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• W1985260537 abstract "We remain cautious and critical of the conclusion of the ISAT trial,1International Subarachnoid Haemorrhage Collaborative GroupInternational Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial.Lancet. 2002; 360: 1267-1274Summary Full Text Full Text PDF PubMed Scopus (2793) Google Scholar and believe that this study has not effectively answered the question of what is the preferred mode of therapy because of fundamental flaws in the study design. This situation is unlikely to improve substantially even with a longer follow-up. Although the study was published as an international trial, 77% were recruited from the UK, 18% from the rest of Europe, 4·15% from Canada, 1·25% from Australia, and 0·09% from the USA. Therefore this trial is based on the practice in the UK, and at best can be called a European trial, since 95% of patients were recruited from Europe. Expertise in the delivery of treatment is a significant factor in the surgical clipping and endovascular coiling of aneurysms: experienced neurosurgeons, interventionalists, and hospitals have better results.2Solomon RA Mayer SA Tarmey JJ Relationship between the volume of craniotomies for cerebral aneurysm performed at New York state hospitals and in-hospital mortality.Stroke. 1996; 27: 13-17Crossref PubMed Scopus (159) Google Scholar, 3Van Linert EJ Bocher-Schwarz HG Pemeczky A The influence of surgical experience on the rate of intraoperative aneurysm rupture and its impact on aneurysm treatment outcome.Surg Neurol. 2001; 56: 151-158Summary Full Text Full Text PDF PubMed Scopus (43) Google Scholar Although the study authors have stated that no discrepancy exists between the expertise of the interventionalist and neurosurgeon, this statement is potentially misleading. The subspecialty of cerebrovascular neurosurgery remains limited in the UK. As far as we know, all the aneurysms treated in the surgical group of ISAT were treated under the supervision of any of the consultant neurosurgeons at that hospital, all of whom were general neurosurgeons. This situation contrasts with that of endovascular treatment, which was almost entirely done by an expert interventionalist. Expertise bias is further reflected in the recruitment bias also evident in the ISAT trial: centres with expertise in endovascular treatment (such as Nottingham and Oxford) provided for most of the patients, but centres with cerebrovascular surgical expertise (such as the National Hospital for Neurological Disorders) provided for a negligible amount. Further expertise bias is the lack of intraoperative or at least postoperative cerebral angiography in the surgical group which has been shown to be effective in demonstrating poorly clipped aneurysms or vessel occlusion.4Le Roux PD Elliott JP Eskridge JM Cohen W Winn HR Risks and benefits of diagnostic angiography after aneurysm surgery: a retrospective analysis of 597 studies.Neurosurgery. 1998; 42: 1248-1254Crossref PubMed Scopus (87) Google Scholar, 5Tang G Cawley CM Dion JE Barrow DL Intraoperative angiography during aneurysm surgery: a prospective evaluation of efficacy.J Neurosurg. 2002; 96: 993-999Crossref PubMed Scopus (160) Google Scholar Angiography is an integral part of treatment during coil emboli-sation, and the procedure is only complete with a satisfactory angiographic result. This lack of intraoperative or postoperative angiography might explain the higher than expected 30-day rebleed rate in the surgical group. Sample bias is one of the most fundamental problems with clinical trials, since no statistical methods can correct for it. Of the 9559 patients who were eligible for inclusion, 78% were excluded. Only 9% of the patients refused to participate, and the remaining 69% were excluded by the treating physician. This is not true randomisation, nor does it represent an intention-to-treat randomised trial. We assume that most patients who could not have been treated by the endo-vascular route were excluded from the trial, since most aneurysms can be treated surgically. This assumption therefore preordains that any treatment failure (complications and inability to do the procedure) that would otherwise be attributed to endovascular therapy be excluded. This sample bias is supported by the facts that middle cerebral-artery aneurysms are under-represented in this study, that 92–93% of aneurysms are 10 mm or less in size, and that more than 50% are 5 mm or less. This finding further adds to the bias in favour of the endovascular treatment route, since endovascular therapy is known to be less favourable than surgical treatment in middle cerebral-artery aneurysms and aneurysms larger than 10 mm in size. To lend credence to the results of this study, readers must know the distribution of treatment and the respective outcome in the patients excluded from the study. In conclusion, we believe that ISAT is important in that it establishes endo-vascular treatment as an option to patients with a ruptured aneurysm, particularly for those not having access to a cerebrovascular surgeon. In the interim, the logical conclusion is that patients with cerebral aneurysm should be treated at large centres where both surgical and endovascular expertise exist, necessitating specialisation in the treatment of cerebrovascular disorders. The ISAT trialAuthors' reply Full-Text PDF" @default.
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• W1985260537 title "The ISAT trial" @default.
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• W1985260537 doi "https://doi.org/10.1016/s0140-6736(03)12407-5" @default.
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