Thirty day results of 227 consecutive carotid stent procedures performed in carotid stenting clinical trials.

BACKGROUND AND PURPOSE

As evidence accumulates that carotid artery stenting (CAS) is a durable and effective procedure for stroke prevention, the utility of the procedure hinges on the perioperative risk. The perioperative risk of CAS procedures has historically been higher than carotid endarterectomy in most clinical trials. The perioperative risk of the series presented here is lower than any previously reported in the context of a clinical trial.

METHODS

Data were collected prospectively from 227 consecutive elective CAS procedures by a single neurointerventionalist performed as part of carotid stenting clinical trials as per the trial protocols, which included randomized trials of "average risk" patients and non-randomized trials of "high risk" patients. The primary outcome measures were 30 day stroke and death, and in most cases 30 day myocardial infarction (MI) also.

RESULTS

Follow-up was 100%. There were no deaths. There was one technical failure. The overall 30 day stroke/death/MI rate was 5/226 (2.2%). There was one MI. The 30 day stroke and death rate for symptomatic patients was 2.5% and for asymptomatic patients 1.4%. Two of the four strokes occurred in vascular territories separate from the target carotid artery.

CONCLUSIONS

The perioperative CAS complications in this series were well below the 6% for symptomatic patients and 3% for asymptomatic patients currently recommended based on historic carotid endarterectomy data. Carotid stenting can be performed safely in the community, provided there are experienced interventionalists and proper patient selection.