Volume 385, Issue 9967, Pages (February 2015)

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(p for noninferiority = 0.01)
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Volume 385, Issue 9967, Pages 529-538 (February 2015) Long-term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis: the International Carotid Stenting Study (ICSS) randomised trial  Leo H Bonati, MD, Joanna Dobson, MSc, Roland L Featherstone, PhD, Jörg Ederle, PhD, H Bart van der Worp, PhD, Gert J de Borst, PhD, Prof Willem P Th M Mali, Jonathan D Beard, ChM, Trevor Cleveland, FRCR, Stefan T Engelter, MD, Philippe A Lyrer, MD, Prof Gary A Ford, FRCP, Paul J Dorman, FRCP, Prof Martin M Brown, FRCP  The Lancet  Volume 385, Issue 9967, Pages 529-538 (February 2015) DOI: 10.1016/S0140-6736(14)61184-3 Copyright © 2015 Bonati et al. Open Access article distributed under the terms of CC BY Terms and Conditions

Figure 1 Trial profile Numbers at screening and excluded before enrolment were not recorded. ITT=intention to treat. *Excluded from the restenosis analysis. † Excluded from per-protocol analysis and restenosis analysis. ‡Excluded from per-protocol analysis. The Lancet 2015 385, 529-538DOI: (10.1016/S0140-6736(14)61184-3) Copyright © 2015 Bonati et al. Open Access article distributed under the terms of CC BY Terms and Conditions

Figure 2 Kaplan-Meier estimates of cumulative incidence for major outcomes (A) Fatal or disabling stroke. (B) Any stroke. (C) Procedural stroke or procedural death or ipsilateral stroke during follow-up. (D) All-cause death. (E) Any stroke more than 30 days after treatment. (F) Ipsilateral stroke more than 30 days after treatment. (G) Contralateral carotid or vertebrobasilar stroke more than 30 days after treatment. (H) Ipsilateral severe (at least 70%) carotid stenosis after completed treatment, generated by life-table analysis. Panels A–D show results for the intention-to-treat population, E–G for the per-protocol population from 30 days after treatment, and H for the per-protocol population from treatment. Percentage values are the estimated cumulative incidence at 1 year and 5 years. Graphs stop at 7 years' follow-up because numbers beyond that time were less than 100, but analyses were based on all follow-up data (maximum 10 years). HR=hazard ratio. CAS=carotid stenting. CEA=carotid endarterectomy. The Lancet 2015 385, 529-538DOI: (10.1016/S0140-6736(14)61184-3) Copyright © 2015 Bonati et al. Open Access article distributed under the terms of CC BY Terms and Conditions

Figure 3 Functional ability measured by the modified Rankin scale at the end of follow-up* A permutation test12 was done to compare scores at the end of follow-up between the two groups: unadjusted, p=0·49; adjusted for baseline modified Rankin scale score, p=0·24. CAS=carotid stenting. CEA=carotid endarterectomy. *Excludes seven patients (three CAS and four CEA) who had no scores recorded during follow-up and were still alive at their final visit. The Lancet 2015 385, 529-538DOI: (10.1016/S0140-6736(14)61184-3) Copyright © 2015 Bonati et al. Open Access article distributed under the terms of CC BY Terms and Conditions