SAPPHIRE Trial
Cordis Endovascular recently released the results of the SAPPHIRE trial (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy).  The vascular surgeons at The Iowa Clinic were part of a physician the SAPPHIRE trial.
The published results of SAPPHIRE included 310 patients.  One hundred fifty-nine patients received stents, and 151 patients underwent traditional surgery.  Patients treated with the stent in this trial were patients who were felt to be at worse than average surgical risk because of advanced age or health-related problems. 

The endovascular procedure involved "cerebral protection" using a filter-type device called AngioGuard in combination with a self-expanding nitinol stent and balloon angioplasty of the carotid artery.  The AngioGuard embolic protection device is comparable to a very small umbrella that can be opened above an area of atherosclerosis.  The "fabric" of the umbrella is a filter that allows blood to flow to the brain while the procedure is being performed. 

Results of the SAPPHIRE Trial
The results at one year demonstrated that only 5.8% of the stent patients had strokes compared to 7.7% of those who had surgery.  The risk of myocardial infarction was 2.5% in the stent patients versus 8.1% of those who had surgery.  The mortality rate was 7% for the stent patients at  one year compared to 12.9% of the surgery patients.

The results of this trial are very exciting regarding treatment of high-risk patients with carotid occlusive disease.  Traditional medical therapy yields significantly worse results.  During the course of The Iowa Clinic's experience with this procedure, there were no strokes or deaths.