Stenting associated with increased risk for stroke, death in patients 70 years or older with symptomatic carotid stenosis

Brown M. Lancet. 2010; doi:10.1016/S0140-6736(10)61009-4.

Issue: November 2010

The short-term risk for stroke or death among patients with symptomatic carotid stenosis was about 50% higher after stenting compared with endarterectomy, according to data from a meta-analysis published in The Lancet.

Researchers from London conducted a prospective meta-analysis of three randomized trials: the Endarterectomy vs. Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial, the Stent-Protected Angioplasty vs. Carotid Endarterectomy (SPACE) trial and the International Carotid Stenting Study (ICSS). The researchers aimed to determine whether carotid artery stenting is a safe alternative to endarterectomy in specific subgroups.

Data for 3,433 patients were pooled and analyzed. The primary outcome was any stroke or death. All patients and outcome events occurring between randomization and 120 days after randomization were included in the intention-to-treat analysis. The per-protocol analysis included only patients receiving the allocated treatment and events occurring within 30 days after treatment, according to the study.

Results from the intention-to-treat analysis demonstrated an increase in stroke or death among the carotid stenting group compared with the carotid endarterectomy group (8.9% vs. 5.8%; RR=1.53; 95% CI, 1.20-1.95). Age was the only variable associated with a significant change in treatment effect: Among patients younger than 70 years, the estimated 120-day risk for stroke or death was 5.8% in the stenting group vs. 5.7% in the endarterectomy group (RR=1.00; 95% CI, 0.68-1.47). The risk for stroke or death with stenting was twice as high as that for endarterectomy among patients at least 70 years (12% vs. 5.9%; RR=2.04; 95% CI, 1.48-2.82).

Data from the per-protocol analysis revealed a similar trend: Among patients younger than 70 years, the estimated risk for stroke or death within 30 days of treatment was 5.1% in the stenting group vs. 4.5% in the endarterectomy group (RR=1.11; 95% CI, 0.73-1.71). The estimated rates were 10.5% for stenting and 4.4% for endarterectomy among patients at least 70 years (RR=1.65; 95% CI, 1.65-3.51).

According to the researchers, their results suggest that stenting may be a reasonable alternative to endarterectomy in younger patients, although the rate for recurrent stenosis may be higher after stenting compared with endarterectomy.

“An approach of offering stenting when technically feasible as an alternative option to endarterectomy to patients younger than 65 to 70 years with symptomatic carotid stenosis, in centers in which acceptable periprocedural outcomes have been independently verified, might seem justified, as long as patients are made aware of a possible increase in the risk of restenosis,” they concluded.

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