Author + information
- Received April 10, 2010
- Revision received October 8, 2010
- Accepted October 15, 2010
- Published online February 1, 2011.
- William A. Gray, MD⁎,⁎ (, )
- Kenneth A. Rosenfield, MD†,
- Michael R. Jaff, DO†,
- Seemant Chaturvedi, MD‡,
- Lei Peng, MSc§,
- Patrick Verta, MD§,
- CAPTURE 2 Investigators and Executive Committee
- ↵⁎Reprint requests and correspondence:
Dr. William A. Gray, Columbia University, Center for Interventional Vascular Therapy, 161 Fort Washington Avenue, Fifth Floor, New York, New York 10032
Objectives The aim of this study was to analyze the CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) study for physician- or site-related variables associated with differential outcomes for carotid artery stenting (CAS).
Background The CAPTURE 2 trial is an ongoing, prospective, nonrandomized, independently adjudicated, multicenter clinical study enrolling high-surgical-risk patients undergoing CAS.
Methods In this assessment of the CAPTURE 2 study, the American Heart Association carotid endarterectomy guideline limits were used to define acceptable site and physician CAS outcomes; therefore, the resulting population of nonoctogenarian, asymptomatic subjects in this analysis is confined to 3,388 (of the total 5,297) subjects treated at 180 U.S. hospitals by 459 operators between March 2006 and January 2009.
Results The rates of death, stroke, and myocardial infarction and death and stroke (DS) at 30 days were 3.5% and 3.3%, respectively, for the full CAPTURE 2 study cohort and 2.9% and 2.7%, respectively, for the asymptomatic, nonoctogenarian subgroup. In this subgroup, two-thirds of sites (118 of 180, 66%) had no DS events. Within the remaining sites, an inverse relationship between event rates and hospital patient volume as well as between event rates and individual operator volume was observed. The DS rates trended lower for interventional cardiologists compared with other specialties.
Conclusions Outcomes from the largest prospectively gathered, independently adjudicated, multicenter CAS study indicate that CAS can be safely performed in a variety of hospital settings by physicians with various specialties. The most important determinant of perioperative CAS outcomes was both site and operator CAS volume. A threshold of 72 cases was found to be necessary for consistently achieving a DS rate below 3% in this later-phase single arm study; background era and non-study operator experience will affect this determination.
(Second Phase of “Carotid RX ACCULINK/RX ACCUNET Post-Approval Trial to Uncover Unanticipated or Rare Events”; NCT00302237)
Dr. Gray is a consultant for and received research grant support from Abbott Vascular. Dr. Rosenfield is a consultant to Abbott Vascular, Complete Conference Management, Harvard Clinical Research Institute, and Lumen; he has equity in Contego, Lumen, and Medical Simulation Corp; he has research support from Abbott Vascular, Bard, and Invatec/Medtronic; and he is a board member for VIVA Physicians. Dr. Jaff is a noncompensated consultant for Abbott Vascular, Boston Scientific, Covidien, and Medtronic Vascular, and he is a member of the Board of Directors for VIVA Physicians. Dr. Chaturvedi is a consultant for Abbott Vascular. Ms. Peng and Dr. Verta are employees of Abbott Vascular and hold stock in Abbott Laboratories.
- Received April 10, 2010.
- Revision received October 8, 2010.
- Accepted October 15, 2010.
- American College of Cardiology Foundation