Volume 375, Issue 9719, Pages (March 2010)

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(p for noninferiority = 0.01)
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Volume 375, Issue 9719, Pages 985-997 (March 2010) Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial    The Lancet  Volume 375, Issue 9719, Pages 985-997 (March 2010) DOI: 10.1016/S0140-6736(10)60239-5 Copyright © 2010 Elsevier Ltd Terms and Conditions

Figure 1 Trial profile Data for the number of patients screened for eligibility were not recorded. The Lancet 2010 375, 985-997DOI: (10.1016/S0140-6736(10)60239-5) Copyright © 2010 Elsevier Ltd Terms and Conditions

Figure 2 Time between randomisation and treatment Cumulative number of patients in whom allocated treatment was initiated per protocol plotted as a proportion of the total number randomised in each group (vertical axis), against the delay between the dates of randomisation and treatment (horizontal axis). Only allocated per-protocol treatment dates were counted. The Lancet 2010 375, 985-997DOI: (10.1016/S0140-6736(10)60239-5) Copyright © 2010 Elsevier Ltd Terms and Conditions

Figure 3 Kaplan-Meier estimates of cumulative incidence of various outcome measures Data were analysed by intention to treat. The numbers above the end of the lines are the incidence estimates at 120 days after randomisation. HR=hazard ratio. The Lancet 2010 375, 985-997DOI: (10.1016/S0140-6736(10)60239-5) Copyright © 2010 Elsevier Ltd Terms and Conditions

Figure 4 Subgroup analysis to compare the rates of stroke, death, or procedural myocardial infarction in different subgroups Subgroups are defined according to baseline characteristics and analysed by intention to treat up to 120 days after randomisation, apart from time from event to treatment, which is analysed per protocol. p values are associated with treatment-covariate interaction tests. *Data are number of events of first stroke, death, or procedural myocardial infarction within 120 days of randomisation/number of patients (Kaplan-Meier estimate at 120 days). †Patients with missing information were excluded from the analysis. ‡Time from the most recent ipsilateral event before randomisation to the date of treatment, analysed per protocol for 30-day procedural events only (results are relative risk and 95% CI at 30 days after treatment). The Lancet 2010 375, 985-997DOI: (10.1016/S0140-6736(10)60239-5) Copyright © 2010 Elsevier Ltd Terms and Conditions

Figure 5 Meta-analysis comparing safety of carotid artery stenting with endarterectomy in the recent carotid stenting trials Odds ratio for any stroke, death, or procedural myocardial infarction within 30 days of treatment in the three recent trials of carotid artery stenting versus endarterectomy including only symptomatic patients. Analysis is based on published results of per-protocol data. The large diamond represents the odds ratio and 95% CI of the combined data. The summary estimate statistic was calculated by use of a Mantel-Haenszel fixed-effect model; the centre of the diamond is the point estimate, and its width the 95% CI. EVA-3S=Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis. SPACE=Stent-Protected Angioplasty versus Carotid Endarterectomy. ICSS=International Carotid Stenting Study. The Lancet 2010 375, 985-997DOI: (10.1016/S0140-6736(10)60239-5) Copyright © 2010 Elsevier Ltd Terms and Conditions