Complications and follow-up after unprotected carotid artery stenting.

Purpose: This prospective study was undertaken to determine the success rate, complications, and outcome of carotid artery stenting (CAS) without the use of cerebral protection devices.

Methods: During 12 months, 94 high-grade stenoses of the carotid artery in 91 consecutive patients were treated. Sixty-six (70%) of the stenoses were symptomatic and 28 (30%) were asymptomatic.

Results: In all 94 carotid stenoses CAS was successfully performed. During the procedure and within the 30 days afterwards, there were 2 deaths and 3 major strokes in the 66 symptomatic patients, resulting in a combined death and stroke rate of 5 of 66 (7%). Only one of these complications, a major stroke, occurred during the procedure. In the 6-month follow-up, one additional major stroke occurred in a originally symptomatic patient resulting in a combined death and stroke rate of 6 of 66 (10%) for symptomatic patients at 6 months. No major complications occurred in asymptomatic patients during the procedure or in the 6-month follow-up period. At 6 months angiographic follow-up the restenosis rate with a degree of >50% was 3 of 49 (6%) and the rate with a degree of >or=70% was 1 of 49 (2%).

Conclusions: Cerebral embolization during CAS is not the only cause of the stroke and death rate associated with the procedure. The use of cerebral protection devices during the procedure may therefore not prevent all major complications following CAS.