Boston Scientific reports positive outcomes from the CABANA post-approval study of the Carotid Wallstent Monorail Endoprosthesis used in conjunction with its FilterWire EZ embolic protection system in routine clinical practice.
Multicentre registry results demonstrate that carotid artery stenting with Carotid Wallstent and FilterWire EZ is a safe alternative to carotid endarterectomy in patients with carotid artery stenosis who are at increased risk for surgery. The analysis was presented by L Nelson Hopkins, chairman of Neurosurgery at the State University of New York in Buffalo, trial investigator and advisory committee member, at the Cardiovascular Research Foundation’s annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco, USA.
The CABANA study enrolled 1,097 patients at 99 sites in the USA. Within the patient population, 32.7% were symptomatic and 67.3% were asymptomatic for carotid artery disease. The primary endpoint of 30-day composite rate of major adverse events, which included stroke, death and myocardial infarction, was 4.6%. The 30-day stroke rate was 3.3%, with the majority of strokes being ipsilateral (occurring on same side as blockage) and ischaemic (resulting from lack of blood flow).
Overall mortality was 1.3% and the rate of myocardial infarction 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 (NIH) stroke scale assessments.
“Results from this post-approval study show low rates of stroke, death, and myocardial infarction, 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,” said 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.”
The Carotid Wallstent Monorail Endoprosthesis is a self-expanding stent with a closed-cell design to provide increased scaffolding for improved lesion coverage and a smooth inner lumen. It features a highly flexible, low-profile stent delivery system designed to provide exceptional tracking through difficult anatomy. The FilterWire EZ embolic protection system is designed to capture plaque debris that may be released during a procedure, preventing it from traveling to the brain, where it could cause a stroke.
“As public discussion continues regarding carotid stenosis therapy, the CABANA study demonstrates our commitment to providing physicians with safe and effective carotid artery stenting treatment options supported by strong clinical evidence,” said Jeff Mirviss, president of Boston Scientific’s Peripheral Interventions business. “The Carotid Wallstent and FilterWire EZ system offer a less-invasive alternative for treating carotid artery disease and can help reduce the risk of stroke, which can have devastating consequences on patients and their families.”
The US Food and Drug Administration (FDA) approved the Carotid Wallstent in 2008. The FilterWire EZ embolic protection system received FDA clearance for use in carotid artery stenting procedures in 2006.