SECOND STUDY CONFIRMS SAFETY, EFFICACY OF CAROTID STENTING

A major study of carotid stenting has reproduced results of a previous large study, showing the treatment is safe and effective for preventing stroke in high-risk patients, the Society of Interventional Radiology announced.

The treatment uses a small filter with the stent, a method known as embolic protection, to catch debris that might break loose during the procedure and minimize procedure-related stroke.

The study measured the 30-day major adverse event (MAE) rate and the one-year MAE rate. The one-year rate included the 30-day rate plus MAEs from 31 days to one year. MAEs -- death, strokes and heart attacks -- were likely to be procedure-related events, according to the study.

The preliminary one-year MAE rate of 11.9 percent in the single-arm CASES-PMS trial is comparable to the 12.2 percent rate observed in the previous SAPPHIRE trial stent cohort, and lower than the 20.1 percent rate observed in the surgical arm of the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy) trial.

The data for this multicenter trial of 1,493 patients adds to evidence that carotid stenting with embolic protection is appropriate for patients at high risk for surgery or whose surgery has failed, the population for whom the treatment is currently approved. The results also substantiate the low adverse event rates previously reported in the SAPPHIRE trial, the authors said. ( http://www.fdanews.com/ddl/34_11/ )