New data from the CASES-PMS Trial support findings from the SAPPHIRE trial that carotid stenting with embolic protection is safe and effective even for high-risk patients, according to a presentation at the annual meeting of the Society of Interventional Radiology.

The multi-center, prospective, single-arm trial enrolled 1,493 patients; analysis of its preliminary one-year data substantiates the low adverse event rates reported previously in the SAPPHIRE trial.

The overall stroke rate in the CASES-PMS trial was 4.8 percent at one year. Physicians of varying experience levels at multiple institutions performed the carotid artery stenting utilizing a formal training program and had similar adverse event rates to the highly experienced experts in the SAPPHIRE trial, showing that the training program is valuable and can contribute to patient safety in introducing a relatively new interventional procedure into the mainstream.

The primary endpoints of the study measured the 30-day major adverse event rate - death, stroke and myocardial infarction - which were likely to be procedure-related events, and the one-year event rate, which included the 30-day rate plus death and same-side stroke from 31 days to one year.

The preliminary one-year cumulative major adverse event rate of 11.9 percent in the CASES-PMS trial is similar to the 12.2 percent rates seen with the SAPPHIRE trial stent cohort, and lower that the 20.1 percent for the surgical arm of the SAPPHIRE trial. The CASES-PMS overall stroke rate at one-year was 4.8 percent (7.0 percent in symptomatic patients and 4.2 percent in asymptomatic).

“Patients with severely blocked carotid arteries are at high risk for stroke, but many patients with vascular disease are not good candidates for surgery. Now we know we can safely offer these high-risk patients carotid stenting, saving many people from future strokes,” sad Barry T. Katzen, MD, interventional radiologist, Baptist Cardiac and Vascular Institute, Miami, FL.