Is stenting a safe and effective alternative to carotid endarterectomy in patients with symptomatic carotid stenosis?

Carotid stenting as currently practiced should be abandoned. It significantly increases the risk of stroke in patients with symptomatic carotid stenosis. (LOE = 1b)

Mas JL, Chatellier G, Beyssen B, et al, for the EVA-3S Investigators. Endarterectomy versus stenting in patients with symptomatic severe carotid stenosis. N Engl J Med 2006;355:1660-1671.  [PMID:17050890]

Randomized controlled trial (nonblinded)

Government

Concealed

Inpatient (any location) with outpatient follow-up

It makes sense that carotid stenting, a less invasive procedure, might be safer than carotid endarterectomy (CE). However, several smaller previous clinical trials have not found an advantage to stenting over CE. This French study included 520 adults with a recent transient ischemic attack (TIA) or nondisabling stroke and a 60% to 99% stenosis in the symptomatic carotid artery. Patients with significant disability, uncontrolled hypertension or diabetes, unstable angina, history of bleeding, or severe proximal or intracranial lesions worse than the cervical lesion were excluded. Allocation to groups was concealed, but the patients and neurologists doing outcome assessment were not blinded. The events committee that assessed stroke, death, and other outcomes was blinded. The goal of the analysis was to determine "noninferiority" at 30 days, but the study was stopped prematurely because of significantly worse outcomes than expected in the stent group. Groups were balanced at the start of the study, analysis was by intention to treat, and the mean age of participants was 70 years. Approximately half had a history of ischemic stroke, and one third had a history of TIA. Only 4% of patients in the stent group had more than 1 stent placed. At 30 days, the risk of nonfatal stroke was much higher in the stent group (8.8% vs 2.7%; number needed to treat to harm [NNTH] = 16; 95% CI, 10 - 47), although the risk of death was similar (1.2% in the CE group vs 0.8% in the stent group). At 6 months, the risk of any stroke or death was 6.1% in the CE group and 11.7% in the stent group (NNTH = 18; 9 - 143).