Accuracy of a novel risk index combining degree of stenosis of the carotid artery and plaque surface echogenicity.

Background and Purpose—The purpose of this study was to determine the accuracy of a risk index in symptomatic or asymptomatic carotid stenoses. Methods—Consecutive patients presenting 50% to 99% carotid stenoses were included. A semiautomated gray scale-based color mapping (red, yellow, and green) of the whole plaque and of its surface was achieved. Surface was defined as the region located between the lumen (Level 0) and, respectively, 0.5, 1, 1.5, and 2 mm. Risk index was based on a combination of degree of stenosis and the proportion of the red color (reflecting low echogenicity) on the surface or on the whole plaque. Results—There were 67 (36%) symptomatic and 117 (64%) asymptomatic carotid stenoses. Risk index values were higher among symptomatic stenoses (0.46 mean versus 0.29; P,0.0001); on receiver operating characteristic curves, risk index presented a stronger predictive power compared with degree of stenosis or surface echogenicity alone. Also, in a regression model including age, gender, degree of stenosis, surface echogenicity, gray median scale of the whole plaque, and risk index, risk index measured within the surface region located at 0.5 mm from the lumen was the only parameter significantly associated with the presence of symptoms (OR, 4.89; 95% CI, 2.7– 8.7; P50.0000002). The best criterion to differentiate between symptomatic and asymptomatic stenoses was a risk index value .0.36 (sensitivity and specificity of 78% and 65%, respectively). Conclusions—Risk index was significantly higher in the presence of symptoms and could therefore be a valuable tool to assess the clinical risk of a carotid plaque. (Stroke. 2012;43:1260-1265.

Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial

Background Stents 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. Methods The 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. Findings The 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). Interpretation Completion 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