Long-term monitoring of patients treated by endosaccular coiling is mandatory.

SummaryBackgroundStents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy.MethodsThe International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470.FindingsThe trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4·0%) events of disabling stroke or death in the stenting group compared with 27 (3·2%) events in the endarterectomy group (hazard ratio [HR] 1·28, 95% CI 0·77–2·11). The incidence of stroke, death, or procedural myocardial infarction was 8·5% in the stenting group compared with 5·2% in the endarterectomy group (72 vs 44 events; HR 1·69, 1·16–2·45, p=0·006). Risks of any stroke (65 vs 35 events; HR 1·92, 1·27–2·89) and all-cause death (19 vs seven events; HR 2·76, 1·16–6·56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=0·0197).InterpretationCompletion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.FundingMedical Research Council, the Stroke Association, Sanofi-Synthélabo, European Union.

SUMMARY:In medical research analyses, continuous variables are often converted into categoric variables by grouping values into Ն2 categories. The simplicity achieved by creating Ն2 artificial groups has a cost: Grouping may create rather than avoid problems. In particular, dichotomization leads to a considerable loss of power and incomplete correction for confounding factors. The use of data-derived "optimal" cut-points can lead to serious bias and should at least be tested on independent observations to assess their validity. Both problems are illustrated by the way the results of a registry on unruptured intracranial aneurysms are commonly used. Extreme caution should restrict the application of such results to clinical decision-making. Categorization of continuous data, especially dichotomization, is unnecessary for statistical analysis. Continuous explanatory variables should be left alone in statistical models.ABBREVIATIONS: ACA ϭ anterior cerebral artery; CHUM ϭ Centre hospitalier de l'Université de Montré al; ICA ϭ internal carotid artery; ISUIA ϭ International Study of Unruptured Intracranial Aneurysms; MCA ϭ middle cerebral artery; Pcirc ϭ posterior circulation; PcomA ϭ posterior communicating artery; SAH ϭ subarachnoid hemorrhage; UIA ϭ unruptured intracranial aneurysms U IAs are common (approximately 2% of the adult population), but they most often remain silent until a rupture occurs (incidence, 2-20/10,000/year).1 No one is sure what to do with them, but with the increasing accessibility of noninvasive imaging of the brain, the problem is growing rapidly. 2A common and yet controversial approach to decisionmaking is to compare the natural history of the disease and the risks of treatment.3,4 One prominent risk factor for rupture of UIAs is size. In 1998, a landmark study on this subject, the ISUIA, estimated from retrospectively obtained data that the risk of rupture of aneurysms smaller than 10 mm was extremely low.5 Subsequent guidelines published in 2000 discouraged the treatment of aneurysms smaller than that size. 6In a 2003 study, the same group, confronted with different results when data were collected prospectively, claimed that aneurysms Ͻ7 mm in a special subgroup of patients (defined by the absence of a history of rupture of another lesion, having an aneurysm located in the anterior circulation, and selected for observation) were at zero risk of rupture, but only when some carotid aneurysms were excluded (PcomA aneurysms). 7Despite these specifications, a threshold of 7 mm is now used by many as a normative criterion for clinical decisions 8 or in cost-effectiveness analyses. 9Size of UIAs can serve to illustrate the problems associated with the categorization of continuous variables, in particular dichotomization. Our aim is to consider how continuous variables should be treated and analyzed when we suspect that risk increases or decreases in proportion to the variable in question. We address the following questions: What are the advantages and disadvantages of categorization? If we de...

Object Procedure-related rupture during endovascular therapy of intracranial aneurysms is associated with a mortality rate of more than one third. Previously ruptured aneurysms are a known risk factor for procedure-related rupture. The objective of this study was to evaluate whether very small, ruptured aneurysms are associated with more frequent intraprocedural ruptures. Methods This was a retrospective cohort study in which the investigators examined consecutive ruptured aneurysms treated with coil embolization at a single institution. The study was approved by the institutional review board. Very small aneurysms were defined as ≤ 3 mm. Procedure-related rupture was defined as contrast extravasation during treatment. Univariate analysis with the Fisher exact test and the Mann–Whitney U test was performed. Results Between August 1992 and January 2007, 682 aneurysms were selectively treated with coils in 668 patients. Procedure-related rupture occurred in 7 (11.7%) of 60 aneurysms ≤ 3 mm, compared with 14 (2.3%) of 622 aneurysms > 3 mm (relative risk 5.2, 95% confidence interval 2.2–12.8; p < 0.001). Among cases with procedure-related rupture, inflation of a compliant balloon was associated with better outcome (Glasgow Outcome Scale Score ≥ 4) compared with patients treated without balloon assistance (5 of 5 compared with 7 of 16; p = 0.05). Death resulting from procedure-related rupture occurred in 8 (38%) of 21 patients, and a vegetative state occurred in 1 patient. Clinical outcome was good in the other 12 patients (57%). Conclusions Endovascular coil embolization of very small (≤ 3 mm) ruptured cerebral aneurysms is 5 times more likely to result in procedure-related rupture compared with larger aneurysms. Balloon inflation for hemostasis may be associated with better outcome in the event of intraprocedural rupture and merits further study.

EVT of UAs can be performed with relative safety. The efficacy of treatment as compared with observation has not been rigorously documented.

In patients considered for thrombectomy, there may be insufficient agreement between clinicians for ASPECTS to be reliably used as a criterion for treatment decisions.

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