GAITHERSBURG, Md. – The majority of a Food and Drug Administration advisory panel on Jan. 26 voted in favor of expanding the approved use of a carotid stent to include patients who are at standard surgical risk, in addition to the previously approved indication for revascularization in patients at high surgical risk.
The FDA’s Circulatory System Devices Panel voted 7 to 3 with 1 abstention that the benefits of the Acculink Carotid Stent, a self-expanding stent made of nickel and titanium manufactured by Abbott Vascular, outweigh the risks when used for the proposed population of patients, at standard surgical risk.
The indication under review is for the treatment of patients at standard risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the following criteria: patients who have neurological symptoms and at least 70% stenosis of the common or internal carotid artery by ultrasound or at least 50% stenosis by angiogram; or patients without neurological symptoms and at least 70% stenosis of the internal carotid artery by ultrasound or at least 60% stenosis by angiogram. Patients must also have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.
In 2004, the Acculink Carotid Stent was approved for use for carotid revascularization in patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet slightly different criteria.
The company filed for approval of the expanded indication to include the lower surgical risk population based on the results of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST), a randomized multicenter noninferiority study conducted in the United States and Canada comparing the outcomes of carotid artery stenting to the preferred method, carotid endarterectomy in patients who met the criteria in the proposed indication. At 1 year, the primary safety and effectiveness end point – death, stroke, and myocardial infarction within 30 days of having the procedure plus the rate of ipsilateral stroke from 31 to 365 days after the procedure, was 7.1% among those who received the stent (1,131 patients) and 6.6% among those who underwent endarterectomy (1,176 patients), a difference that met the prespecified criteria for noninferiority.
Different components of the composite end point – periprocedural MIs and strokes – were elevated among patients in the two arms: In the stent arm, the rate of strokes was 4.1%, compared with 1.9% in the surgical arm. MI at 30 days was 3.4% in the surgical arm, compared with 2% in the stent arm. Panelists varied on their opinions on the clinical significance of these differences.
The Acculink stent is approved in over 90 countries and more than 128,000 have been distributed worldwide, according to Abbott Vascular.
The CREST study was funded by Abbott Vascular, and was created by NIH and the New Jersey Medical School, Newark. The FDA usually follows the recommendations of its advisory panels.
The FDA usually follows the recommendations of its advisory panels. Panel members have been cleared of potential conflicts of interest by the FDA prior to the meeting. Occasionally, the FDA grants a waiver to a panelist with a conflict but not at this meeting.