Two-year data from the BEACH Trial suggest that patients at high risk for endarterectomy can receive carotid artery stents with low risk for stroke and with long-term efficacy, according to a presentation at the annual Transcatheter Cardiovascular Therapeutics symposium.

The study evaluated the effectiveness of stenting with embolic protection for patients who were at high-risk for carotid endarterectomy using the WALLSTENT(R) Monorail(R) Endoprosthesis and FilterWire EX(R) Embolic Protection System and, later, the FilterWire EZ(TM) Embolic Protection System.

It is a prospective, non-randomized, single-arm clinical trial that enrolled 480 patients in the pivotal phase of the trial. These patients were considered high risk for surgery because they had either anatomical issues such as tortuous vessels or co-morbid conditions.

The BEACH study's two-year results continue to evaluate long-term safety and efficacy. The ipsilateral stroke rate steadily declined from 3.1 percent from 0-30 days, to 2.3 percent from 31 days to one year, to 0.9 percent between one and two years. The BEACH study also demonstrated declining death rates from 7.5 percent through one year to 6.1 percent between one and two years.

In addition, long-term efficacy was evaluated with ultrasound data indicating a continued reduction in mean maximum peak systolic velocity. The progressive reduction in velocity from 346 cm/sec before the stenting procedure to 130 cm/sec out to two years post-procedure suggests no progressive restenosis from 6 months to 2 years.

"Surgery was not an attractive option for these patients who are at increased risk for stroke," said Christopher White, MD, co-principal investigator of the BEACH study. "These results are encouraging because they suggest Boston Scientific's carotid artery stenting system may not only minimize the risk of stroke after the procedure, but may be a durable treatment with the incidence of stroke declining over time."