Carotid Stent Maker Seeks Expanded FDA Indication
May 27, 2010 – Positive results from CREST (Carotid Revascularization Endarterectomy vs. Stenting Trial) will be used to expand the U.S. Food and Drug Administration (FDA) indication for carotid stents. All carotid stent systems in the United States are currently indicated only for patients who are considered to be at high risk for surgical treatment due to anatomical factors, age or other considerations. The expanded indication being sought would allow stent use in the majority of patients with carotid artery disease who are not part of this high-risk group.
Abbott hopes to expand the use of Acculink stent in patients with carotid artery disease who are at standard risk for surgery.
The study was published this week in The New England Journal of Medicine. In this trial, stenting and surgery had similar initial safety and longer-term outcomes for symptomatic and asymptomatic men and women. Adverse event rates of death, stroke and heart attack were also similar for both therapies.
Abbott’s Acculink carotid stent system and Accunet embolic protection system were used in the study. The study was sponsored by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), and partially funded by Abbott.
Abbott will submit the results of a preagreed-upon analysis of the CREST data to the FDA in an application seeking an expanded indication for the Acculink carotid stent as a treatment option for patients at standard surgical risk. Abbott will seek Medicare coverage for standard-risk patients if the FDA approves the treatment for this broader patient group.
"As a neurosurgeon who has performed both carotid surgeries and carotid stenting procedures, I am pleased to see that carotid stenting and carotid surgery had comparable outcomes for a majority of standard-risk patients in this trial," said L. Nelson Hopkins III, M.D., chairman of neurosurgery, professor of radiology, and director of the Toshiba Stroke Research Center at the University at Buffalo, State University of New York. “Both therapies met the American Heart Association guidelines for patients with carotid narrowing. Experience, training and patient selection will continue to be of paramount importance in determining success for both treatments.”
CREST demonstrated results consistent with long-standing American Heart Association (AHA) guidelines for outcomes in patients with a severe carotid stenosis. These guidelines state that rates of death and stroke for carotid artery surgery within 30 days of the procedure be less than 3 percent for asymptomatic patients and less than 6 percent for symptomatic patients.
CREST is a randomized, multicenter clinical trial comparing outcomes of carotid artery stenting and carotid surgery in symptomatic and asymptomatic patients with carotid artery disease.
In the study, stenting and surgery had similar initial safety and longer-term outcomes for symptomatic and asymptomatic men and women. The study showed equivalent low rates of adverse events for either procedure in the 2,502 patients studied, with 6.8 percent of surgery patients and 7.2 percent of stenting patients experiencing a primary endpoint of death, stroke or heart attack event in the periprocedural period (during the procedure and within approximately 30 days thereafter) and ipsilateral strokes up to four years after the procedure (mean follow-up of 2.5 years).
In the periprocedural period, 5.2 percent of surgery patients and 4.5 percent of stenting patients experienced any of these adverse events, with a rate of stroke of 2.3 percent in the surgical patients and 4.1 percent in the stenting group, and a rate of heart attack of 2.3 percent in the surgical group and 1.1 percent in the stenting group. After the periprocedural period, the incidence of ipsilateral stroke was similar for stenting (2 percent) and surgery (2.4 percent).
The rate of cranial nerve palsy during the periprocedural period was 4.7 percent for the surgical group and 0.3 percent for the stenting group (representing crossover stenting patients who also underwent the surgical procedure). Cranial nerve palsy refers to a temporary injury of the nerves that run close to the carotid artery, potentially causing difficulty with speaking, swallowing and facial expressions. It is not a complication of stenting.
ACT I Trial
In addition to CREST, Abbott is currently enrolling patients in ACT I – an additional randomized clinical trial of patients at standard risk for surgical treatment, which will include up to 1,658 asymptomatic patients under the age of 80. This multicenter study compares carotid surgery to Abbott’s second carotid stent and embolic protection system – the Xact rapid exchange carotid stent system and the Emboshield family of embolic protection systems.
Abbott is the only company with two distinct carotid stent and embolic protection systems approved by the FDA and on the market in the United States.
For more information: www.abbott.com