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,
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,
Statistical analysis: Nissen, Thompson, Berman,
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.
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).