The goal of the trial was to evaluate whether carotid artery stenting (CAS) was noninferior to carotid endarterectomy (CEA) among patients with symptomatic carotid artery stenosis.

Patients with symptomatic carotid artery stenosis of ≥60% were randomized to CAS (n = 265) or CEA (n = 262). The trial, conducted in France, was publicly funded and not sponsored by a device company. To avoid using sites without experience, the trial required that a minimum number of cases had been performed by both the surgeon and the interventionalist in order to participate in the trial. Following an amendment, stents with cerebral protection devices were to be used.

At 4 years, for CAS vs. CEA, the use of an antiplatelet agent was 99% vs. 95%, an antihypertensive agent was 87% vs. 86%, and the use of lipid-lowering medication was 82% vs. 83%.

The trial was stopped early after an increased hazard was observed with carotid stenting over endarterectomy. The primary composite endpoint of death or stroke was more than double in the CAS group compared with the CEA group (9.6% vs. 3.9%, relative risk [RR] 2.5, 95% confidence interval [CI] 1.2-5.1, p = 0.01). Even after the amendment regarding use of stenting with cerebral protection (n = 277), death or stroke was higher with CAS compared with CEA (RR 3.4, 95% CI 1.1-10.0).

Results were similar regardless of physician experience or center volume. Nonfatal stroke was significantly higher in the CAS group (8.8% vs. 2.7%, RR 3.3, 95% CI 1.4-7.5, p = 0.004), including disabling stroke (2.7% vs. 0.4%) and non-disabling stroke (6.1% vs. 2.3%). Mortality did not differ between the groups (0.8% vs. 1.2%, p = 0.68). Bradycardia or hypotension occurred more frequently within the stenting group (4.2% vs. 0%, p < 0.001). Nerve injury was more common in the CEA group (7.7% vs. 1.1%, p < 0.001). At 6 months, the composite of death or stroke remained higher in the stenting group (11.7% vs. 6.1%, p = 0.02).

Type of stent used was Carotid Wallstent Monorail (56.9%), Acculink (28.5%), and Precise RX (10.6%). Cerebral protection was used in 92% of CAS patients.

At 4 years, death or any stroke had occurred in 26.9% of the CAS group vs. 21.6% of the CEA group (p = 0.08), and any ipsilateral stroke had occurred in 11.1% of the CAS group vs. 6.2% of the CEA group (p = 0.03).

Among patients with symptomatic carotid artery stenosis, treatment with CAS was associated with a 2.5 times higher rate of death or stroke by 30 days compared with CEA. For every 17 patients treated with stenting rather than endarterectomy, one additional stroke or death occurred. Use of distal protection devices did not appear to alter the early results of the increased hazard with stenting. This safety difference was minimized in long-term follow-up.

By 4 years, death or any stroke was no longer increased in the CAS arm, although there was a nonsignificant excess in the CAS arm. A significant excess of ipsilateral strokes still remained in the CAS group at 4 years.

The present trial adds to the body of evidence examining the long-term safety of carotid stenting for symptomatic carotid artery stenosis. The recent SPACE trial failed to show that carotid stenting was noninferior to endarterectomy at 30 days, although outcomes were similar by 2 years.

Carotid stenting for treatment of symptomatic carotid artery stenosis was approved by the Food and Drug Administration based mainly on data from the SAPPHIRE trial, the only randomized trial to show noninferiority of carotid stenting compared with endarterectomy. Approximately 30% of the patients in SAPPHIRE were symptomatic and there was no benefit of stenting compared with endarterectomy in this patient subgroup. Since then, large randomized trials have failed to show noninferiority or have shown an increased hazard with carotid stenting in symptomatic patients with early follow-up. With long-term follow-up, the difference between these treatment modalities appears to be minimized.

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