SIR: Carotid Stenting Safe Even in Less Experienced Hands

March 9, 2007

SEATTLE -- Carotid stenting with embolic protection was as safe and effective in a real-world registry trial as it was in phase III trials that led to FDA approval, researchers said here.

SEATTLE, March 9 -- Carotid stenting with embolic protection was as safe and effective in a real-world registry trial as it was in phase III trials that led to FDA approval, researchers said here.

The one-year stroke rate was 4.8% for the CASES postmarketing study of the Cordis Precise Nitinol Stent and Angioguard XP Emboli Capture Guidewire System, said Barry T. Katzen, M.D., of the Baptist Cardiac and Vascular Institute in Miami, and colleagues.

That rate compares favorably with the 4.9% stroke rate for carotid stenting and the 5.8% endarterectomy-associated stroke rate in the SAPPHIRE trial, Dr. Katzen said at the Society of Interventional Radiology meeting.

Cumulative major adverse events were also comparable between trials (12.2% SAPPHIRE versus 11.9% CASES-PMS).

Moreover, the safety and efficacy were independent of the operators' experience, he said.