Presented by study leaders Italo Linfante, MD, and Ajay Wakhloo, MD, interventional neuroradiologists at the University of Massachusetts, the study outcomes lend yet one more voice to the ongoing debate regarding the effectiveness and efficacy of the minimally invasive carotid artery stenting in the very elderly population.

According to Linfante, "The study was initiated on the premise that elderly patients with blockage in the internal carotid artery often have no treatment options." Intravenous tPA, the traditional treatment for stroke (blockage of a vessel in the brain), is not effective on carotid blockages and surgical intervention (carotid endarterectomy) is considered high risk for this age group.

Treatment for blocked carotids in the 80+ age range takes on added importance given the fact that stroke is the second cause of death in the very elderly. In addition, 30 to 60% of strokes in this age group are secondary to blockage in the carotid artery.

The single-center study, conducted from 2001 to 2004, included 178 patients total, with 24 patients 80 years or older. The sample included patients labeled moderately to severely ill, with 70.8% being symptomatic (having suffered a mini-stroke, stroke or visual symptoms) and one out of two presenting with severe coronary artery disease.

All patients underwent carotid artery stenting, a procedure in which a stent is inserted through a catheter directly to the site of the blockage and placed in such a way that the plaque causing the blockage is pushed against the artery wall, thereby opening the vessel. Distal protection devices, umbrella-shaped material that serves to "catch" pieces of breakaway plaque (that could cause strokes if they traveled through the blood vessels up into the brain) were used when possible. A neurologist evaluated patients pre- procedure, 24 hours, 30 days, six months and one year post-procedure.

Study outcomes revealed a procedural success rate of 100% with a remaining narrowing of the artery of less than 20%. Thirty-day follow up revealed one heart attack, one mini-stroke and one blockage in the femoral artery in the symptomatic group. There were no deaths at 30 days, six months or one-year follow up, and no re-blockage at one-year follow up and evaluation.

The available data on stenting in patients over 80 years old is controversial. The Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), initiated in 2004, is the largest trial to date to test these treatments side by side in the 80+ population. In the lead-in phase of the trial, patients with symptomatic and asymptomatic carotid blockages were evaluated. As the 30-day stroke and death rates increased with age to become 12.1% in patients over 80 years old, the trial committee excluded octogenarians in the lead-in phase of the trial.

Another 2004 trial, SAPPHIRE, comparing endarterectomy vs. stenting in high-risk patients (across the adult population to include the 80+), showed that stenting is safer, resulting in less incidence of mini-stroke, stroke or heart attacks.

Linfante says his single-center study presented a unique opportunity to focus on the value of carotid artery stenting in the very delicate 80+ population. As many in this age group are in desperate need of treatment, and not all can successfully enter a randomized trial, the study facilitated "another piece of evidence that carotid artery stenting is indeed effective, even in this high-risk population."

"Of course, we need to continue to test these results in the larger randomized trials," said Linfante, "but these results do challenge us as medical practitioners to adjust our thinking regarding what we can offer the very elderly. In the past, many of these patients were simply abandoned as they were considered too high-risk. I think the scientific evidence is beginning to show that we can treat them -- and treat them successfully."