Boston Scientific Announces Excellent Results in BEACH Trial

Boston Scientific has announced one-year data from its carotid artery stenting (CAS) clinical trial known as BEACH, evaluating the effectiveness of stenting with embolic protection for patients who are at high-risk for carotid endarterectomy (CEA), the surgical treatment for carotid artery disease.

The BEACH trial was designed to evaluate Boston Scientific's Carotid WALLSTENT Monorail Endoprosthesis (Carotid WALLSTENT) and the FilterWire EX and EZ Embolic Protection Systems. It is a prospective, nonrandomized, single-arm clinical trial that enrolled 747 patients at 47 U.S. sites, with 480 patients in the pivotal phase of the trial. The trial also enrolled 189 patients in a "roll-in" group and 78 patients in a bilateral registry.

The trial has a composite primary endpoint of cumulative mortality and morbidity through one year, consisting of stroke, death and myocardial infarction (MI). Trial data showed a composite one-year endpoint of 9.1 percent. The breakdown of patients experiencing one or more events is as follows: stroke, 7 percent; death, 3.2 percent; and MI, 1.1 percent. The BEACH results suggest that CAS may ultimately be a viable treatment option for this high-risk population.