Did Carotid Stenting and Endarterectomy Outcomes Change over Time in the Carotid Revascularization Endarterectomy Versus Stenting Trial? (S09.005)

Abstract

Objective: To detect changes in the periprocedural outcomes in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) following carotid endarterectomy (CEA) and carotid artery stenting (CAS) to detect temporal changes, if present. Background Improvements in training and technique as well as improvements in selection of surgeons and interventionists had the potential to influence differential outcomes in CREST for the 2502 patients randomized between December of 2000 and mid-July of 2008. Design/Methods: Enrollment was divided into 3 consecutive epochs, each with approximately 834 patients. Rates for the primary outcome of stroke, death, and MI (SDMI) and for stroke and death (SD) during the periprocedural period were calculated. Poisson regression was used to adjust rates for age, sex, dyslipidemia, and symptomatic status, all of which were found to influence outcomes. Results: For CAS, there was a 26% decline in SDMI (6.2% a 4.6%) and a 35% decline in SD (5.5% a 3.6%). For both composite endpoints in CEA there was no consistent pattern. As CREST progressed, it enrolled younger patients, more men, and patients more likely to be dyslipidemic (all p Conclusions: Periprocedural safety for CAS improved over time in CREST. Changes were inconsistent for CEA. Improvements for CAS in part appear to reflect changes in patient selection related to age, sex, risk factors, and symptomatic status because adjustment for those variables attenuated the decline in rates. Linking rates to operator experience was not feasible because of the large number of new interventionists and surgeons entering CREST over time. Supported by: The National Institute of Neurological Disorders and Stroke (NINDS) and the NIH (R01 NS 038384) and by supplemental funding from Abbott Vascular Solutions (formerly Guidant). Disclosure: Dr. Howard has received personal compensation for activities with Bayer Healthcare and Abbott Labratories as a consultant. Dr. Howard has received research support from Amgen Inc. and Bayer Healthcare. Dr.Roubin has received royalty payments from Abbott Vascular and Cook Inc. Dr. Hopkins has received personal compensation for activities with Boston Scientific, Micrus, Abbott Labratories, W. L. Gore, BARD, Cordis Corporation, Memorial Healthcare System as a consultant an/or speaker.Dr. Hopkins holds stock and/or stock options in Micrus, Boston Scientific, AccessClosure, Valor Medical, Claret Medical, Inc., and Augmenix.Dr. Hopkins has received research support from Toshiba. Dr. Moore has received personal compensation for activities with WL Gore. Dr. Gray has received personal compensation for activities with Abbott Vascular as a consultant and a participant on an advisory board. Dr. Rosenfield has received personal compensation for activities with Abbott Vascular, Complete Conf Management, Contego Medical, LLC, and HCRI as a consultant.Dr. Rosenfield has received personal compensation for serving on the Board of Directors of VIVA Physicians. Dr. Rosenfield has received royalty or license fee or contractual rights payments from Angiograd (Cordis).Dr. Rosenfield holds stock and/or stock options in Contego Medical, LLC and Medical Simulation Corp. Dr. Rosenfield has received research support from Abbott Vascular. Dr. Katzen has received personal compensation for activities with Boston Scientific, W.L. Gore, and Medtronic as a consultant and particpant on an advisory board. Dr. Chakhtoura has nothing to disclose. Dr. Morrish has nothing to disclose. Dr. Ferguson has nothing to disclose. Dr. Hye has nothing to disclose. Dr. Shawl has received research support from Abbott, Medtronic, Boston Scientific, Johnson & Johnson, and Ev3. Dr. Harrigan has nothing to disclose. Dr. Voeks has nothing to disclose. Dr. Lal has nothing to disclose. Dr. Meschia has nothing to disclose. Dr. Brott has received personal compensation for activities with 3D Communications.