October 29, 2007 - Boston Scientific Corp. announced positive three-year results from its CABERNET and BEACH carotid artery stenting clinical trials, which evaluated the effectiveness of stenting with embolic protection for patients at high risk for carotid endarterectomy (CEA), the surgical treatment for carotid artery disease.
The three-year CABERNET and BEACH results were presented by L. Nelson Hopkins, M.D., Chairman of Neurosurgery, Department of Neurosurgery, State University of New York, Buffalo, NY, at the annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C. Dr. Hopkins reported that the CABERNET major stroke rate was 1.3 percent at 30 days and 2.8 percent at three years. The reported BEACH major stroke rate was 1.7 percent at 30 days and 8.1 percent at three years. According to the three-year CABERNET data, the ipsilateral stroke rate (a stroke occurring on the treated side of the neck) was 2.9 percent at 30 days and by three years had only increased to 4.9 percent. In the BEACH trial, the ipsilateral stroke rate was 3.1 percent at 30 days and by three years had only increased to 7.7 percent.
"The three-year results suggest not only an immediate benefit for patients treated with Boston Scientific's NexStent Carotid Stent and FilterWire EZ Embolic Protection System, but also a longer-term benefit in reducing the incidence of stroke over time," said Dr. Hopkins, Co-Principal Investigator of the CABERNET and BEACH clinical trials. "In particular, the CABERNET three-year trial results are very encouraging and continue to demonstrate the long-term efficacy and durability associated with Boston Scientific's NexStent Carotid Stent when used with the Company's FilterWire EZ Embolic Protection System in treating patients at high risk for carotid endarterectomy."
The CABERNET clinical trial was designed to evaluate the safety and efficacy of Boston Scientific's NexStent Carotid Stent and FilterWire EZ Embolic Protection System, while the BEACH clinical trial was designed to evaluate the safety and efficacy of the Company's Carotid WALLSTENT Monorail Endoprosthesis and FilterWire EZ Embolic Protection System. CABERNET and BEACH were both prospective, non-randomized, single-arm clinical trials enrolling 454 patients and 480 patients, respectively, who were at high risk for CEA.
"We continue to be excited about the favorable results being reported from the CABERNET and BEACH trials now out to three years," said John Pedersen, President of Peripheral Interventions of Boston Scientific. "The three-year data provide further evidence of the benefits of the NexStent Carotid Stent and FilterWire EZ Embolic Protection System in treating patients at risk for stroke, as well as the potential clinical benefits of Carotid WALLSTENT Endoprosthesis. These trials are indicative of our commitment as a Company to evaluate the long-term safety and efficacy of our products in treating carotid artery disease."
The NexStent Carotid Stent is a closed cell, nitinol stent with a rolled sheet design that enables one stent size to adapt to multiple diameters in tapered or non-tapered vessel configurations. The Carotid WALLSTENT Endoprosthesis is a self-expanding stent with a braided, closed cell design. Closed-cell configurations are designed to increase lesion coverage and provide a smooth inner lumen to help facilitate delivery and retrieval of ancillary devices. The FilterWire EZ System -- an advanced technology designed for simplicity and effectiveness -- captures debris efficiently, simplifies filter sizing and is easy to deliver and retrieve. When compared to surgical alternatives, this system provides a less-invasive way to treat patients with carotid artery disease.
The U.S. FDA has approved the NexStent Carotid Stent and FilterWire EZ Embolic Protection System for use in patients with carotid artery disease who are at high risk for CEA. The Carotid WALLSTENT Endoprosthesis is an investigational device currently under FDA review and is subject to investigational use only under U.S. Federal law.
The carotid arteries, located on either side of the neck, are the main conduit for blood flow to the brain. Plaque formation in these arteries can lead to carotid occlusive disease, putting patients at risk for stroke. Stroke is the third leading cause of death in the United States, killing nearly 160,000 Americans every year, and is the leading cause of serious, long-term disability in the U.S.
For more information: http://www.bostonscientific.com/