Corresponding Author: Steven E. Nissen, MD, Department of Cardiovascular Medicine, Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195 ([email protected]).
Financial Disclosures: Dr Nissen has received research support from and is an unpaid consultant to Astra Zeneca, Sankyo, Takeda, Pfizer, Lipid Sciences, Sanofi, Eli Lilly, Atherogenics, and Novartis. Dr Tuzcu has received research support and lecture honoraria from Pfizer. Dr Libby has received research support from and is a consultant to Pfizer. Drs Garza and Berman, Ms Buebendorf, and Mr Shi are Pfizer employees. Dr Topol has not received any financial or research support from Pfizer and has not served as a consultant for the company.
Author Contributions: Dr Nissen had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Nissen, Tuzcu, Garza, Buebendorf, Topol.
Acquisition of data: Nissen, Tuzcu, Thompson, Ghali, Garza, Shi, Buebendorf, Topol.
Analysis and interpretation of data: Nissen, Tuzcu, Libby, Garza, Berman, Shi, Topol.
Drafting of the manuscript: Nissen, Tuzcu, Thompson, Garza, Berman, Buebendorf, Topol.
Critical revision of the manuscript for important intellectual content: Nissen, Tuzcu, Libby, Thompson, Ghali, Garza, Berman, Topol.
Statistical analysis: Nissen, Thompson, Berman, Shi.
Obtained funding: Nissen, Tuzcu, Thompson.
Administrative, technical, or material support: Nissen, Tuzcu, Thompson, Garza, Berman, Buebendorf, Topol.
Study supervision: Nissen, Tuzcu, Libby, Thompson, Garza, Berman, Topol.
Steering Committee: E. J. Topol, MD, Cleveland Clinic, Ohio; B. Pitt, MD, University of Michigan, Ann Arbor; D. Hunninghake, MD, Minneapolis, Minn; C. O'Connor, MD, Duke University, Durham, NC.
IVUS Substudy Steering Committee: S. E. Nissen, MD, Cleveland Clinic, Cleveland, Ohio; P. Libby, MD, Brigham and Women's Hospital, Boston, Mass; E. Murat Tuzcu, MD, Cleveland Clinic, Cleveland, Ohio; R. Waksman, MD, Washington Hospital Center, Washington, DC.
Data and Safety Monitoring Board: C. H. Hennekens, MD, University of Florida, Boca Raton; B. G. Brown, MD, PhD, University of Washington, Seattle; T. Fleming, PhD, University of Washington, Seattle; D. O'Leary, MD, New England Medical Center, Boston, Mass.
End Point Adjudication Committee: A. B. Miller, MD, Jacksonville, Fla; R. Nesto, MD, Boston, Mass; G. Vetrovec, MD, Richmond, Va; R. DiBianco, MD, Washington, DC; J. Abrams, MD, Albuquerque, NM.
IVUS Core Laboratory: T. Churchill, J. Coughlin, T. Crowe, D. Hansen, A. Loyd, W. Magyar, P. Schoenhagen, MD, P. Shalling, C. Werle, B. Wong, J. Zhitnik.
CAMELOT Investigators (by country):Canada: *Laurel Cardiology, Vancouver (D. Ricci, MD); *Montreal Heart Institute, Montreal (J. Tardif, MD).
France: Groupe Hospitalier Cochin, Paris (S. Weber, MD); Unite d Hemodinamique et di Cardiologie Interventionnell, Cretiel (Prof P. Dupuoy); Hospital Cardiologique, Lyon (Prof M. Ovize).
Germany: *Essen University Clinic, Essen (D. Baumgart, MD).
Italy: *Ospedale San Raffaele, Milan (C. DiMario, MD, F. Arinoldi, MD). *Ospedale San Martino Di Genova, Genova (F. Miccoli, MD, G. Terzi, MD); *Ospedale San Giovanni–Addolorata, Rome (F. Prati, MD); *Istituto Clinico Humanitas, Rozzano (P. Presbitero, MD); Divisone di Cardiolgia–Policlinico Universita Federico II, Napoli (Prof M. Chiariello); Policlinico Universita Divisone di Cardiolgia, Palermo (Prof E. Hoffman); *Azienda Osedaliera Deparmento Malatti Cardiovascolari, Siena (Prof A. Bravi).
United States: Alabama: *University of Alabama, Birmingham (J. Canto, MD, V. K. Misra, MD); Heart Center, Huntsville (W. H. Haught, MD). Arizona: University Medical Center Cardiology, Tucson (P. Fenster, MD); Affiliated Cardiologists of Arizona, Phoenix (N. Laufer, MD); Maricopa Medical Center Cardiology Services, Phoenix (R. Patel, MD, R. Asher, MD, E. Zavala-Alarcon, MD); Desert Cardiology of Tucson, Tucson (M. Jerman, MD); Southern Arizona VA Health Care System, Tucson (D. Morrison, MD); Phoenix Heart, PLLC Cardiovascular Center (F. Cucher, MD). Arkansas: Heart Center Arkansas, Little Rock (S. W. Hutchins, MD); Sparks Regional Medical Center, Fort Smith (J. Schwarz, MD, E. Rivera, MD); *St Edward Mercy Medical Center, Clinical Research, Fort Smith (R. D. Foreman, DO). California: *San Diego VA Medical Center, San Diego (W. F. Penny, MD); *San Diego Cardiovascular Associates, San Diego (G. W. Dennish, MD); *Huntington Memorial Hospital, Pasadena (J. Heger, MD); Los Angeles Cardiology Associates, Los Angeles (T. L. Shook, MD); San Diego Cardiac Center, San Diego (L. Favrot, MD, D. Marsh, MD). Connecticut: Hartford Hospital, Hartford (P. D. Thompson, MD). District of Columbia: *Washington Hospital Center (R. Waksman, MD); George Washington University Medical Center (J. Reiner, MD). Georgia: Atlanta Cardiology Group, PC (K. McGrath, DO). Florida: *Florida Cardiovascular Research, Atlantis (M. Lakow, MD); *Florida Cardiovascular Institute, Tampa (F. Matar, MD); *University of Florida Health Center, Jacksonville (P. S. Gilmore, MD); *Florida Heart Associates, Fort Myers (J. F. Butler, DO, M. Rubin, MD); *MIMA Regional Research Associates, Melbourne (R. Vicari, MD); Pharmquest Clinical Research, Leesburg (D. Lew, MD); Greater Fort Lauderdale HeartGroup Research, Fort Lauderdale (A. L. Niederman, MD); Mediquest Research Group Inc, Ocala (R. L. Feldman, MD); South Florida Research Group, LLC, Miami (P. Seigel, MD); Watson Clinic, LLP, Lakeland (C. L. Simek, MD); Charlotte Heart Group, Port Charlotte (M. Lopez, MD); Ocala Research Institute, Ocala (R. Prashad, MD). Hawaii: St Francis Hospital, Honolulu (S. Dacanay, MD). Illinois: *Rush-Presbyterian-St Luke's Medical Center, Chicago (R. J. Snell, MD); *Loyola University Medical Center, Maywood(Mirck Sochanski, MD); Heart Care Midwest, Peoria (B. S. Clemson, MD); Carter Cardiovascular Clinic, Calumet City (J. E. Carter, Jr, MD). Indiana: *Care Group, LLC, Indianapolis (M. N.Walsh, MD); *Midwest Medical Group, LLC, South Bend (M. Lampert, MD, D. R. Westerhausen, MD); Heart Group, Evansville (J. Becker, MD). Iowa: *Iowa Heart Center, Des Moines (M. G. H. Ghali, MD); Iowa Heart Center Research Center, Des Moines (P. Bear, MD). Kentucky: Cardiovascular Associates, PSC, Louisville (W. Dillon, MD, D. A. Dangeforde, MD). Louisiana:*Tulane University School of Medicine, New Orleans (J. G. Diez, MD, A. N. Tenaglia, MD); Cardiovascular Institute of the South, Thibodaux (B. G. Denys, MD); Cardiovascular Institute of the South, Houma (P. S. Fail, MD); Cardiovascular Institute of the South, Morgan City (P. Abel, MD); Cardiovascular Institute of the South, New Iberia (M. Changlani, MD). Maine: *Androscoggin Cardiology Associates, Auburn (R. J. Weiss, MD). Maryland: University of Maryland, Baltimore (J. L. Stafford, MD). Massachusetts: Boston Medical Center, Boston (R. Falk, MD). Michigan: *University of Michigan Medical Center, Division of Cardiology, Ann Arbor (S. Werns, MD, S. Chetcuti, MD); *Mc MD); Cardiology Consultants Ltd, Norfolk (R. Stine, MD). Washington: *VA Puget Sound Health Care Center, Seattle (K. Lehmann, MD, S. Kapadia, MD). Wisconsin: Cardiovascular Associates of Northern Wisconsin SC, Wausau (T. N. Logemann, MD); Kenosha Hospital and Medical Center, Kenosha (K. J. Fullin, MD); Marshfield Clinic Wausau Center, Wausau (R. Srivastava, MD).
*Indicates IVUS site.
Funding/Support: This study was funded by Pfizer.
Role of the Sponsor: The sponsor, Pfizer, participated in discussions regarding study design and protocol development and provided logistical support during the trial. Monitoring of the study was performed by a contract research organization, Covalent, under contract with the sponsor, and maintained the trial database. The IVUS end points were prepared by the Intravascular Ultrasound Core Laboratory at the Cleveland Clinic. Primary statistical analysis was performed by Pfizer. All tables, listings, and analyses were performed and created by the writing group. After completion of the trial, as specified in the study contract, a complete copy of the database was transferred to the Cleveland Clinic Cardiovascular Coordinating Center, in which primary efficacy analyses were verified by independent statisticians (Marlene Goormastic, MPH, Kathy Wolski, MPH, and Craig Balog, BS). The manuscript was prepared by the corresponding author and modified after consultation with coauthors. The sponsor was permitted to review the manuscript and suggest changes, but the final decision on content was exclusively retained by the authors.
Acknowledgment: We acknowledge the contributions made by Nadine Juran, RN (study coordinator; Cleveland Clinic), Tim Crowe, BS (IVUS laboratory manager), Marlene Goormastic, MPH, Kathy Wolski, MPH, Craig Balog, BS (statisticians; Cleveland Clinic), Mathieu Ghadanfar, MD, David J. Frid, MD (medical officer; Pfizer), Rebecca Scherzer, MS, Sarah Young, PhD, Michael Gaffney, PhD, (statisticians; Pfizer).
