Two-year data from the BEACH (Boston Scientific EPI-A Carotid Stenting Trial for High Risk Surgical Patients) carotid artery stenting (CAS) clinical trial
Indicates that stenting maybe a durable treatment with the incidence of stroke declining over time. The results were presented at the Cardiovascular Research Foundation’s (CRF) eighteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, DC.
The BEACH study is evaluating the effectiveness of stenting with embolic protection for patients who are at high-risk for carotid endarterectomy (CEA).
The BEACH trial was designed to evaluate Boston Scientific’s Carotid Wallstent Monorail Endoprosthesis and the FilterWire EX Embolic Protection System and later the FilterWire EZ 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 or co-morbidity factors making surgery too risky.
The BEACH study’s two-year results revealed that the ipsilateral stroke rate steadily declined from 3.1% from 0-30 days, to 2.3% from 31 days to one year, to 0.9% between one and two years. The BEACH study also demonstrated declining death rates from 7.5% through one year to 6.1% 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 six months to 2 years.
Dr Christopher White, Chairman of the Department of Cardiology and Director of the Ochsner Heart & Vascular Institute in New Orleans, LA, and co-principal investigator of the BEACH study, commented, “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.”
The Wallstent is a self-expanding stent with a braided, closed cell design. The FilterWire EZ Embolic Protection System is a low-profile filter designed to capture embolic debris released during a procedure. The stent is an investigational device in the US and is limited by US law to investigational use. The safety and effectiveness of the FilterWire EZ Embolic Protection System for use in carotid arteries has not been established in the US and is currently investigational.
Closed cell design
Meanwhile, the results from the new study presented by Dr Barry T Katzen, Medical Director, Baptist Cardiac & Vascular Institute, Miami, FL, at the annual meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) recently held in Rome, Italy, suggest that patients treated with the Wallstent have a significantly lower incidence of hypotension, compared with patients treated with slotted-tube nitinol stents.
The single-center, retrospective study examined 172 patients with de novo carotid artery lesions, 31 of which received the Carotid Wallstent. The remaining patients received slotted-tube nitinol stents, which included Acculink (Abbott/Guidant), Precise (Cordis), Smart (Cordis), Xact (Abbott) and Vivexx (Bard).
The overall incidence of hypotension (procedural and 24-hour post-procedure) was 19.4% in Wallstent group, compared with 40.4% in slotted-tube nitinol stent recipients (p=0.014). The incidence of periprocedural hypotension (24-hour post-procedure) was 12.9% in Wallstent group, compared to 31% in slotted-tube nitinol stent recipients (p=0.045).
As carotid artery stenting becomes a mature technique, it is important to look at the subtle differences between technologies that could affect patient care,” said Katzen, the study’s principal investigator.