One-year data from the Boston Scientific EPI-A Carotid Stenting Trial for High Risk Surgical Patients (BEACH) carotid artery stenting clinical trial have been presented at the 28th Annual Scientific Sessions of the Society for Cardiac Angiography and Interventions (SCAI). The study evaluates the effectiveness of stenting with embolic protection for patients who are at high-risk for carotid endarterectomy. The results were presented by Dr Christopher White, Co-Principal Investigator of the trial and Director of the Ochsner Heart and Vascular Institute in New Orleans and Chairman of Ochsner's Department of Cardiology.
The BEACH trial was designed to evaluate Boston Scientific's Carotid WallStent Monorail Endoprosthesis and the FilterWire EX and EZ Embolic Protection Systems. It is a prospective, non-randomised, single-arm clinical trial that enrolled 747 patients at 47 US sites, with 480 patients in the pivotal phase of the trial. One hundred and eighty-nine patients were also enrolled in a "roll-in" group and 78 patients in a bilateral registry. Symptomatic patients enrolled in BEACH had stenosis of 50% or greater, and asymptomatic patients had stenosis of 80% or greater.
The trial has a composite primary endpoint of cumulative mortality and morbidity through one year, consisting of stroke, death and myocardial infarction (MI). White presented data showing a composite one-year endpoint of 9.1%. The breakdown of patients experiencing one or more events is as follows: stroke, 7.0%; death, 3.2%; and MI, 1.1%.
Event rates were similar for the roll-in group and bilateral registry. The roll-in group, in which physicians trained on the Boston Scientific devices before entering the pivotal group, reported an event rate of 8.7%. The bilateral group, consisting of patients with carotid artery disease requiring treatment in both carotid arteries, reported an event rate of 7.1%. Bilateral patients are more difficult to treat than patients with carotid artery disease in only one artery, and have largely not been studied as standalone populations in previous trials. The BEACH results suggest that carotid artery stenting may ultimately be a viable treatment option for this high-risk population.
"These results are well within the trial objectives we hoped to meet. They suggest that carotid artery stenting with embolic protection is a viable treatment option in the high-risk patients represented by this study. The roll-in results suggest there is a minimal additional learning curve in this complex patient subset, which is important information when planning physician training and ensuring patient safety," commented White.
The Carotid WallStent is a self-expanding stent with a braided, closed cell design. The FilterWire EZ Embolic Protection System is a low-profile filter mounted on a Monorail deployment system designed to capture embolic debris released during a procedure and prevent it from travelling to the brain, where it could cause a stroke.
Both devices carry the CE mark and are commercially available in Europe and certain other international markets. The Carotid WallStent is an investigational device in the US, with the FilterWire EZ and EX Embolic Protection Systems also under investigation in the US for use in carotid arteries.
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