Advisory panel votes to expand indication of carotid stenting system

The Circulatory System Devices Advisory Panel recommended expansion of the indication of Abbott Vascular’s RX Acculink Carotid Stent System, answering affirmative to three votes that questioned the safety, efficacy and risk to benefit ratio of the device.

The vote came after presentations from Abbott Vascular and the FDA, which centered on data from the CREST trial, and the panel’s deliberation on whether the results from the trial could provide assurance of safety for carotid artery stenting in patients with carotid artery stenosis at standard risk for adverse events from carotid endarterectomy.

The three voting questions posed to the panel included whether there was reasonable assurance that the stenting system is safe for patients in the proposed indication, whether it is effective in this population and whether the benefits of the device outweigh the risk. The final tally was 6-4 with 1 abstention that the device is safe, 8-2 with 1 abstention that it is effective, and 7-3 with 1 abstention that the benefits outweigh the risk.

Among the panel members who voted yes on all questions included Michael A. Ferguson, MD, of the Long Island Jewish Medical Center, New Hyde Park, New York, who said he felt comfortable recommending approval because his concerns over the increased stroke risk with carotid artery stenting were mitigated by the data showing operator experience dramatically improved the stroke rates.

“My vote is really contingent upon ensuring that experienced operators are performing this procedure,” he said. “I also think that we need to be careful about the indications for the procedure and it should be confirmed angiographically if you’re just dependent upon noninvasive evaluation for sending the patients to the stenting.”

John C. Somberg, MD, with the Rush University Medical Center, Lake Bluff, Illinois, said of his three no votes that “the population at low-risk is a more difficult one to gain an indication for and I was disturbed by the poor quality of the follow-up and adherence to the protocol and the inconsistencies of the data, which I hope can be corrected.”

Regarding the overall vote, said Richard L. Page, MD, with the University of Wisconsin at Madison, “I feel that the panel got this [vote] right, because if this were a 100% in favor I don’t think this would reflect my own angst about this because there is angst … This is a high-risk procedure, but I feel like we are in the right place and that’s with an affirmative vote but not a unanimous one.” – by Brian Ellis

I am very happy about the panel’s decision. The CREST trial was a very rigorous trial. I was involved with that trial, and all operators and even stenting physicians were required to undergo scrutiny before being allowed to be part of the protocol. For the first time we took a significant amount of the bias out by the surgeons and interventionalists randomizing patients and collecting the data in a very judicious manner and coming up with the results we did. With expanded coverage, we will be able to treat more patients or patients that are the more typical patients as opposed to the high-risk patients that we were mandated to treat with the previous decision.

– Tyrone J. Collins, MD

Director, Cardiac Catheterization Lab, Ochsner Medical Center, New Orleans

Chairman, Carotid Artery Stenting and Neurovascular Committee,

Society for Cardiac Angiography and Interventions