Boston Scientific's Postapproval CABANA Study of Carotid Wallstent Presented at TCT

November 8, 2011—Boston Scientific Corporation (Natick, MA) announced positive outcomes from the CABANA postapproval study of the company's carotid Wallstent Monorail endoprosthesis used in conjunction with its FilterWire EZ embolic protection system in routine clinical practice. L. Nelson Hopkins, MD, presented the analysis at the annual Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco.

The company stated that the multicenter registry results showed that carotid artery stenting with the Wallstent and FilterWire EZ is a safe alternative to carotid endarterectomy in patients with carotid artery stenosis who are at increased risk for surgery.

“Results from this postapproval study show low rates of stroke, death, and myocardial infarction (MI), demonstrating that the carotid Wallstent and FilterWire EZ can be used in carotid stenting procedures as a safe alternative to surgery in high-risk patients,” commented Dr. Hopkins. “In my clinical practice, I have found that the user-friendly design of this stenting system contributes to successful outcomes in patients with carotid artery stenosis at increased risk for surgery.”

According to Boston Scientific, the CABANA study enrolled 1,097 patients at 99 sites in the United States. Within the patient population, 32.7% were symptomatic and 67.3% were asymptomatic for carotid artery disease. All patients were high risk for carotid endarterectomy because of prespecified anatomical criteria and/or medical comorbidities.

The primary endpoint of a 30-day composite rate of major adverse events, which included stroke, death, and MI, was 4.6%. The 30-day stroke rate was 3.3%, with the majority of strokes being ipsilateral and ischemic. The overall mortality rate was 1.3%, and the rate of MI was 0.5% at 30 days. Technical success was achieved in 97.1% of patients. Follow-up at 30 days included clinical evaluation and independent neurologic and National Institutes of Health stroke scale assessments.

Boston Scientific advised that the carotid Wallstent Monorail endoprosthesis is a self-expanding stent with a closed-cell design, which provides increased scaffolding for improved lesion coverage and a smooth inner lumen. The device features a highly flexible, low-profile stent delivery system that is designed to track through difficult anatomy. The FilterWire EZ embolic protection system is designed to capture plaque debris that may be released during a procedure. The US Food and Drug Administration approved the device in 2008, and it is available in all major markets worldwide. The FilterWire EZ received US Food and Drug Administration clearance for use in carotid artery stenting procedures in 2006.