Is there evidence that cerebral protection is beneficial? Clinical data.

Advances in angioplasty techniques and the development of low-profile, flexible, tapered nitinol stents designed specifically for carotid applications have made carotid artery stenting a viable alternative to carotid endarterectomy for treatment of occlusive disease of the carotid arteries. During the stenting process, however, debris may be released and cause distal embolization that can lead to stroke or death. Thus, several embolic protection devices have been developed for use in carotid stenting, two of which are available in the United States. In the past 5 years, data from several large trials, series, and registries of carotid artery stenting-reflecting the experience in thousands of patients-have become available. These investigations include the CAVATAS study, the Global Carotid Artery Stent Registry, the SAPPHIRE study, the ARCHeR trials, the CABERNET registry, the BEACH registry, the SECuRITY registry, the German Registry, and the EVA-3S trial. The studies have provided considerable evidence that use of an embolic protection device decreases the incidence of cerebral embolic events during carotid stenting in both symptomatic and asymptomatic patients. They have also shown that increased experience with angioplasty in the carotid artery decreases complication rates associated with the procedure, even when a protection device is not employed. Although the benefits of routine use of cerebral protection have not been confirmed by level 1 evidence, a consensus supports such use.