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In several large trials involving patients with symptomatic carotid artery stenosis, endovascular stenting carried greater periprocedural risk than open endarterectomy, but no single trial was large enough to identify subgroups that might be at particular risk with either procedure. To gain statistical power, investigators combined patient-level data from three such trials, yielding a sample of 3454 patients with moderate-to-severe stenosis who were assigned randomly to stenting or endarterectomy.
In an intent-to-treat analysis, significantly more patients assigned to stenting than to endarterectomy reached the primary outcome of any stroke or death within 120 days after randomization (8.9% vs. 5.8%) — a difference that was driven primarily …