Trial findings suggest that carotid stenting to prevent stroke in high-risk diabetic patients may be both more effective and safer than endarterectomy at 1-year follow-up, according to a presentation at the annual meeting of the Society of Interventional Radiology (USA).

The current study involved a total of 334 high-risk patients who were randomized and treated by either stenting with embolic protection or surgery in the overall multi-center SAPPHIRE trial; the high-risk diabetic subset, which was the group analyzed in the current project, was composed of 86 patients. This diabetic population was at high risk for adverse events, and some at extreme risk; for example they couldn’t walk across the room, had unstable angina, or already had bypass surgery, or other heart disease.

The stenting group had a 2.4 percent incidence of myocardial infarction compared with an 18.2 percent incidence in the surgical group. Incidence of major bleeding was 4.8 percent for the stenting group versus 20.5 percent for the surgery group. The 1-year major adverse event rate -- which included death, stroke, and myocardial infarction in first 30 days plus same-side stroke and deaths due to stroke from 31 to 360 days -- was 4.8 percent for stenting versus 25 percent for surgery.

The study also collected 30-day event rates for myocardial infarction, stroke of any type, or death. The 30-day event rate for stroke, myocardial infarction, and death was 4.8 percent for stenting and 22.7 percent for carotid surgery, a difference that was statistically significant.

The findings are based on data of the high-risk diabetic arm of the SAPPHIRE trial, a prospective, multi-center, randomized, controlled trial at 29 U.S. centers comparing the safety and efficacy of carotid stenting with embolic protection to standard carotid surgery to prevent stroke. The products used in the study, were the PRECISE(TM) Stent with the ANGIOGUARD(TM) Filter.

“These findings are quite significant because diabetics are at greater risk for all vascular events. This study shows that stenting is far safer than surgery even in this highest-risk population. It clearly establishes that all high-risk diabetics should have stenting, not surgery,” said presenter Mark Wholey, M.D. a SAPPHIRE trial principal investigator.

He added, “Patients with severely blocked carotid arteries are at high risk for stroke. These findings offer hope for those patients who need treatment of their carotid artery disease to prevent stroke, but were too high risk to have the surgery. Now we know we can safely offer them carotid stenting.”