Starting a carotid artery stenting program is safe

Background : Little is known on the performance of newly initiated carotid artery stenting (CAS) programs. The safety of the procedure is being questioned following the publication of the EVA‐3S trial, a study criticized for the limited interventional experience required to enroll patients. Methods : Within a newly started academic CAS program, patient data and outcomes were collected prospectively. The outcomes of the first 100 consecutive patients treated are reported. A CAS‐fellowship‐trained interventionalist was involved in all procedures. All patients underwent clinical assessment by a neurologist before and after the procedure, and serial ECG and cardiac enzymes were routinely obtained. Primary outcome measures included 30‐day major adverse events (MAE), defined as death, stroke, or myocardial infarction, while on follow‐up deaths and ipsilateral strokes were added. Results : Between July 2003 and November 2006, 92 patients had a single internal carotid artery treated, while 7 underwent staged bilateral CAS. In one patient, the procedure was aborted prior to lesion treatment. The 30‐day MAE rate per procedure was 1.9% (one major and one minor stroke). By a mean follow‐up of 16 months (range 2–42 months), one patient had died of refractory heart failure, while one patient had a minor ipsilateral stroke and three had minor contralateral strokes, corresponding to total MAE per patient of 4%. The rate of any stroke or death was 7%. The rate of restenosis ≥50% per lesion by ultrasound was 3.8%. Conclusion : This single center experience suggests that it is safe to start a CAS program following dedicated fellowship. © 2008 Wiley‐Liss, Inc.