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.

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Conclusion:In Medicare beneficiaries, repair of isolated, intact abdominal aortic aneurysms (AAA) by endovascular means is associated with a lower risk of all-cause mortality and AAA-related mortality than repair using open techniques.Summary: Randomized clinical trials (RCTs) have failed to demonstrate a long-term survival advantage of endovascular repair vs open repair of AAA. Furthermore, a previous study of Medicare beneficiaries undergoing AAA repair between 2001 and 2004 also failed to demonstrate a survival advantage of endovascular repair over open repair beyond 3 years of follow-up (Schemerhorn ML et al, N Engl J Med 2008;358:464-74). It is possible current endovascular devices may provide improved overall results of endovascular repair than those available for analysis of endovascular vs open AAA repair in the previous study of Medicare beneficiaries. The authors, therefore, decided to compare overall and AAA-specific mortality, readmission, and reintervention after endovascular vs open repair of nonruptured AAAs in Medicare beneficiary patients using a database from 2003 to 2007. This was a retrospective analysis of patients aged Ն65 years in the Medicare standard analytic file, 2003 to 2007, who underwent isolated repair of an intact AAA. The national death index was used to determine cause of death. Primary outcome was all-cause mortality. Secondary outcomes were AAA-related mortality, hospital length of stay, 1-year readmission, repeat AAA repair, incisional hernia repair, and lower extremity amputation. The Medicare standard analytic files contained data from a 5% example of Medicare inpatient discharges. The study included 4029 patients; of these, 703 underwent open repair and 3826 underwent endovascular repair. Mean and median follow-up times were 2.6 (SD, 1.5) and 2.5 (interquartile range, 2.4) years, respectively. After adjusting for emergency admission, age, calendar year, sex, race, and comorbidities, there was a higher risk of both all-cause mortality (hazard ratio, 1.24; 95% confidence interval [CI], 1.05-1.47; P ϭ .01) and AAA-related mortality after open vs endovascular repair (hazard ratio, 4.37l; 95% CI, 2.51-7.66; P Ͻ .001). Adjusted hospital length of stay averaged 6.5 days (95% CI, 6.0-7.0 days; P Ͻ .001) longer after open repair (mean, 10.4 days) compared with endovascular repair (mean, 3.6 days). Need for incisional hernia repair was higher after open AAA (P Ͻ .001). The 1-year readmission rates, repeat AAA repair, and lower extremity amputation did not differ by repair type.Comment: The data presented here do not demonstrate inferiority of endovascular vs open AAA repair. However, there are really too many deficiencies in the data to justify a conclusion that the data demonstrate superiority of endovascular vs open repair of AAAs. First, follow-up is relatively short and the number of patients analyzed quite small compared with the number potentially available for analysis. In addition, the Medicare database does not contain information about aneurysm configuration and other anato...

An obesity paradox exists for stroke and mortality after CEA; for stroke, but not mortality, this protective association was independent of patient demographics and comorbidities. Obesity is not a contraindication to CEA, and surgeons may safely undertake CEA in obese patients when indicated.