Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel meeting on the ACCULINK and ACCUNET Carotid Artery Stent System.

T he Circulatory System Devices Panel of the Medical Devices Advisory Committee to the US Food and Drug Administration (FDA) was convened on January 26, 2011, to review the application by Abbott Vascular (Santa Clara, CA) for a post–market approval supplement (PMA-s) to extend the indications for use of their ACCULINK Carotid Stent System. The stent system had received FDA approval in 2004 for patients at high risk for adverse events after carotid endarterectomy (CEA). Abbott Vascular was seeking to extend its approval to patients at standard risk for CEA on the basis of the data and outcomes derived from the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST; ClinicalTrials.gov Identifier NCT00004732). Herein are presented the essential elements of that day-long meeting. The organizational work on the CREST project was initiated in 1996 by the project's executive committee, which first published on its concept, rationale, and design in 1997. 1 The experiential basis for the trial was chiefly 2 small stenting registries in high-surgical-risk, symptomatic patients totaling Ϸ200 procedures and reporting mortality rates of up to 3% and stroke rates of between 3% and 6%. 2,3 The CREST executive committee recognized the novel nature and early stage of the technique, and in accordance with the tenets of clinical equipoise, as well as to provide reassurance to randomizing physicians that a reasonable safety of carotid artery stenting (CAS) had been established at an operator level and across sites, a rigorous credentialing phase was detailed for all participating centers. One of the stated secondary goals of CREST, to describe this experience in the lead-in phase of CREST, has been completed and published elsewhere. 4 Although a 3-year enrollment period was originally anticipated for the main randomized trial, based on 50 sites recruiting 20 symptomatic patients per year, CREST ultimately required nearly 8 years and 120 centers to complete enrollment. Some of this delay can be ascribed to the pace of center certification given the aforementioned CAS credentialing requirements and the lack of qualified operators early in the course of the trial; although there were 47 centers selected to participate in CREST as of June 2001 (6 months after the initial patient was randomized), only 8 centers were approved to enroll lead-in CAS patients, and only a single center was qualified to randomize patients. 5 CREST received its operational funding from the National Institutes of Health, National Institute of Neurological Disorders and Stroke (NIH-NINDS) …