Over the past 2 to 3 years, there has been a rapid increase in the use of new technology for treating patients with extracranial carotid stenosis. In particular, embolic protection systems for carotid stenting are now available.

There is an increasing body of observational and prospective, randomized data on outcomes of stenting with embolic protection. This growing experience can help physicians decide what is the best treatment option for carotid stenosis.

The major question is whether stenting is better than standard carotid endarterectomy in patients who would be suitable for either procedure. Dr. Roubin said that the current data suggest carotid stenting is the ideal treatment for a variety of high-risk patients. This includes patients with contralateral occlusions, patients with short and obese necks, and patients who have undergone prior carotid endarterectomy, and others.

Here at the AHA 2002 meeting, an investigator presented randomized data to support use of stenting in high-risk patients. This data came from SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy). It is a multicenter, prospective trial of stenting with embolic protection vs. carotid endarterectomy.

In SAPPHIRE, risk of adverse events in the first 30 days was twice as high for endarterectomy than for carotid stenting. This was true for death, myocardial infarction, stroke events and out of hospital events. The significant improvement in outcomes occurred in both symptomatic and asymptomatic patients.

Dr. Roubin said that because of these positive results, no one should doubt that carotid stenting with protection is at least equivalent to endarterectomy for high-risk patients. In fact, it may be superior.

Carotid stenting has other advantages. It is minimally invasive and can be performed as an outpatient procedure or day case. There is no general anesthesia or sedation. Patients are ambulatory within 2 to 4 hours.

Stenting may be equivalent to endarterectomy for all patients, not just the high-risk ones. Observational data suggest that embolic protection systems have dramatically changed outcomes overall in carotid stenting.

Dr. Roubin's group now has experience with embolic protection devices in more than 1,200 cases. Annualized stroke event rates have dramatically improved. In the most recent 465 patients who underwent stenting with embolic protection, the risk of stroke was 1.3%.

This consecutive series includes high- and low- risk patients. Compared to an earlier series, the rate of strokes is significantly lower. Dr. Roubin said there is no doubt that using protection devices has made a significant difference in the management of patients at Lenox Hill Hospital.

This is particularly true for older patients who receive carotid stenting. At Lenox Hill, the rate of fatal and non-fatal strokes in patients over 80 years old was almost 17% without embolic protection devices, compared with about 2% with protection.

Even in low-risk patients, 30-day stoke rate dropped from 3%, which is acceptable by AHA standards, to less than 1%.

Multivariate analysis on the entire series of 1,200 cases showed that use of embolic protection was the most potent negative predictor of an event.

These data have now been reproduced in many centers and in many different countries. A few investigators have published results of embolic protection trials in peer-reviewed journals. In 7 such studies, combined rates of stroke or death range from 0% to 4%. There are now many other trials underway in the United States, incorporating more than 2,400 patients. In addition, there is a worldwide registry of 13,000 patients.