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In high-risk patients with severe carotid artery stenosis, stenting with an emboli-protection device provides long-term outcomes comparable with those of endarterectomy, according to the latest results of the SAPPHIRE study.

"In high-risk patients with severe carotid artery stenosis, stenting with an emboli-protection device provides long-term outcomes comparable with those of endarterectomy, according to the latest results of the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) study.

In an earlier analysis of the SAPPHIRE data, Dr. Donald E. Cutlip and colleagues had shown that stenting is not inferior to endarterectomy for outcomes at 30 days and at one year. The present analysis, reported in The New England Journal of Medicine for April 10, describes the results seen at three years.

By three years, the prespecified endpoint of death, ipsilateral stroke or MI (within 30 days of treatment) had occurred in 24.6 per cent of stent-treated patients. The corresponding rate in the surgery group was higher, but not significantly different -- 26.9 per cent.

The study involved 334 high-risk patients who had symptomatic carotid stenosis of at least 50 per cent or asymptomatic stenosis of at least 80 per cent. Follow-up data at three years were available for 260 patients, including 85.6 per cent of those in the stenting group and 70.1 per cent of those in the surgery group.

Criteria for high-risk status included one or more of the following: age over 80 years, clinically significant cardiac disease (heart failure, abnormal stress test, or need for open-heart surgery), severe pulmonary disease, contralateral carotid blockage, contralateral laryngeal-nerve palsy, recurrent stenosis after carotid endarterectomy, and prior radical neck surgery or radiotherapy to the neck.

Fifteen strokes occurred in each group, the report indicates. Eleven of the strokes in the stenting group and nine of those in the surgery group were ipsilateral.

Reflecting on the results, the authors conclude that "we could not demonstrate a significant difference between protected carotid artery stenting and carotid endarterectomy with respect to the risk of stroke or other major adverse events in our high-risk patients at three years."

They add, "We also found no evidence of an increased risk of repeat revascularization within three years after treatment."