Clinical Question: Is stenting safe and effective for high-risk patients with carotid stenosis?

Setting: Inpatient (any location) with outpatient follow-up

Study Design: Randomized controlled trial (single-blinded)

Allocation: Concealed

Synopsis: This study included adults with a greater than 50 percent symptomatic lesion or a greater than 80 percent asymptomatic lesion and one of the following characteristics: clinically significant heart disease, severe pulmonary disease, contralateral carotid stenosis or laryngeal nerve palsy, previous surgery or radiation to the neck, age older than 80 years, or recurrent stenosis following carotid endarterectomy. The treating physicians had to agree that patients were candidates for surgery and stenting, even if they would not have qualified for previous clinical trials. Randomization and allocation concealment were appropriate, and outcomes were assessed blindly. The mean age of the patients was 72 years, 67 percent were men, and 26 percent had diabetes.

Of the 334 patients randomized to stenting or carotid endarterectomy, eight did not undergo stenting and 16 did not undergo surgery, primarily because of deterioration in their conditions. Therefore, the complete group of 334 patients made up the intention-to-treat analysis, while the smaller group of 310 patients who received the assigned treatment made up the per-protocol analysis.

After one year, the likelihood of stroke or death at 30 days or ipsilateral stroke or neurologic death from 31 days to one year was not significantly different (5.5 versus 8.4 percent). The authors added myocardial infarction to the original combined end point and, in that way, were able to achieve statistical significance (12.2 versus 20.1 percent;P = .05, number needed to treat = 12). This type of post-study data analysis creates the potential for a bias in favor of finding an effect. Symptomatic patients treated with stenting had similar outcomes to those treated with carotid endarterectomy; asymptomatic patients appeared to do better.

Bottom Line: Carotid stenting appears to provide similar outcomes to carotid end-arterectomy for carefully selected high-risk patients. This trial creates an optimal set of circumstances for performance of the stent, so the borderline advantage of stenting seen when myocardial infarction is included as an outcome deserves further study. (Level of Evidence: 1b)