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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.

In this randomized pilot study, designed to obtain efficacy and safety estimates, preoperative coronary revascularization in high-risk patients was not associated with an improved outcome.

Objective-In a previous in vitro study we have demonstrated that atherosclerotic plaque components can be characterized with multidetector computed tomography (MDCT) based on differences in Hounsfield values (HV). Now we evaluated the use of MDCT in vivo to characterize and quantify atherosclerotic carotid plaque components compared with histology as reference standard. Methods and Results-Fifteen symptomatic patients with carotid stenosis (Ͼ70%) underwent MDCT angiography before carotid endarterectomy (CEA). From each CEA specimen 3 histological sections and corresponding MDCT images were selected. The HV of the major plaque components were assessed. The measured HV were: 657Ϯ416HU, 88Ϯ18HU, and 25Ϯ19HU for calcifications, fibrous tissue, and lipid core, respectively. The cut-off value to differentiate lipid core from fibrous tissue and fibrous tissue from calcifications was based on these measurements and set at 60 HU and 130 HU, respectively. Regression plots showed good correlations (R 2 Ͼ0.73) between MDCT and histology except for lipid core areas, which had a good correlation (R 2 ϭ0.77) only in mildly calcified (0% to 10%) plaques. Conclusions-MDCT is able to quantify total plaque area, calcifications, and fibrous tissue in atherosclerotic carotid plaques in good correlation with histology. Lipid core can only be adequately quantified in mildly calcified plaques. Key Words: carotid stenosis Ⅲ computerized tomography Ⅲ magnetic resonance imaging Ⅲ imaging T he severity of luminal stenosis, caused by the atherosclerotic plaque in the carotid bifurcation, is an important risk factor for (recurrent) stroke and is used in therapeutic decision making: ie, patients with symptomatic or asymptomatic carotid stenosis above a certain degree are considered candidates for carotid intervention such as carotid endarterectomy (CEA) or stent placement. 1 However, morphology studies on carotid atherosclerotic plaque have revealed that plaque morphology could be an important additional feature in the risk assessment of patients with carotid stenosis. 2,3 Computed tomography angiography (CTA) is an accurate modality to grade the severity of stenosis 4 and is increasingly used in the evaluation of stroke patients. The question then arises whether CT can also provide detailed information about plaque morphology.Earlier studies in which 3-mm-thick single-slice CT images were compared with histology sections of CEA specimens yielded confusing results. 5,6 Multidetector CT (MDCT) allows evaluating carotid atherosclerosis with thinner slices (0.5 to 1.0 mm) and less volume averaging. More detailed analysis of plaque composition may now become possible.A previous in vitro validation study showed that thin-section MDCT is capable of characterizing and quantifying calcifications and lipid core regions in CEA specimens based on differences in Hounsfield values (HV). 7 However, in vitro studies have inherent limitations attributable to the presence of air around the specimen and the absence of contrast in the vessel lumen. The purpose ...

In patients undergoing vascular surgery, perioperative fluvastatin therapy was associated with an improvement in postoperative cardiac outcome. (Current Controlled Trials number, ISRCTN83738615.)