Published Online: March 13, 2006 (doi:10.1001/jama.295.13.jpc60002).
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, Nicholls, Libby, Raichlen, Ballantyne, Davignon, Erbel, Tardif, Schoenhagen, Goormastic, Tuzcu.
Acquisition of data: Nissen, Nicholls, Tardif, Schoenhagen, Crowe, Tuzcu.
Analysis and interpretation of data: Nissen, Nicholls, Sipahi, Libby, Raichlen, Davignon, Erbel, Fruchart, Tardif, Schoenhagen, Crowe, Cain, Wolski, Goormastic, Tuzcu.
Drafting of the manuscript: Nissen, Libby, Fruchart, Tuzcu.
Critical revision of the manuscript for important intellectual content: Nissen, Nicholls, Sipahi, Libby, Raichlen, Ballantyne, Davignon, Erbel, Tardif, Schoenhagen, Crowe, Cain, Wolski, Goormastic, Tuzcu.
Statistical analysis: Nissen, Nicholls, Sipahi, Cain, Wolski, Goormastic.
Obtained funding: Nissen.
Administrative, technical, or material support: Nissen, Nicholls, Schoenhagen, Crowe, Tuzcu.
Study supervision: Nissen, Raichlen, Erbel, Tardif, Tuzcu.
Financial Disclosures: Dr Nissen has received research support from AstraZeneca, Eli Lilly, Pfizer, Takeda, Sankyo, and Sanofi-Aventis. He has consulted for a number of pharmaceutical companies without financial compensation. All honoraria, consulting fees, or other payments from any for-profit entity are paid directly to charity, so that neither income nor any tax deduction is received. Dr Libby has received honoraria for lectures and consulting on behalf of AstraZeneca. Dr Ballantyne has received grants or research support from AstraZeneca, diaDexus, Gene Logic, GlaxoSmithKline, Integrated Therapeutics, Kos, Merck, Novartis, Pfizer, Roche, Sankyo Pharma, Sanofi-Synthelabo, and Schering-Plough; has consulted for AstraZeneca, Bayer, Merck, Novartis, Pfizer, Reliant, Roche, Sanofi-Synthelabo, and Schering-Plough; and has served on the speakers' bureaus for AstraZeneca, Kos, Merck, Pfizer, Reliant, and Schering-Plough. Dr Davignon has received research support and consulting fees from AstraZeneca. Dr Tardif holds a Pfizer and Canadian Institute of Health Research Chair in Atherosclerosis, partially funded by Pfizer, and has received honoraria from Pfizer and AstraZeneca. No other financial disclosures were reported.
Funding/Support: This study was funded by AstraZeneca.
Role of the Sponsor: The sponsor participated in discussions regarding study design and protocol development and provided logistical support during the trial. Monitoring of the study and maintenance of the trial database was performed by a contract research organization, Omnicare, under contract to the sponsor. The IVUS end points were verified by the Cleveland Clinic Cardiovascular Coordinating Center. Statistical analysis was performed by the sponsor and the contract research organization under contract with the sponsor. The manuscript was prepared by the corresponding author and modified after consultation with the other authors. The sponsor was permitted to review the manuscript and suggest changes, but the final decision on content was exclusively retained by the authors.
Independent Statistical Analysis: An independent statistical analysis was conducted by Kathy Wolski, MPH, and Marlene Goormastic, MPH, both from the Department of Cardiovascular Medicine at the Cleveland Clinic Foundation. These statisticians received the trial database simultaneously with the sponsor, which included all raw data, not just derived data sets, and independently computed the IVUS efficacy parameters and confirmed the lipid level outcomes and basic demographic variables. Mss Wolski and Goormastic are employed by the Cleveland Clinic Cardiovascular Coordinating Center, which received compensation for conducting the trial, including reimbursement for statistical services.
ASTEROID Investigators:Australia: John Hunter Hospital, New Lambton, New South Wales (G. Bellamy, MD); Wesley Medical Center, Auchenflower, Queensland (D. Colquhoun, MD); Austin and Repatriation Medical Center, Heidelberg, Victoria (M. Horrigan, MD). Belgium: Hôpital de la Citadelle, Liege (P. Materne, MD); Onze Lieve Vrouw Ziekenhuis, Aalst (G. Heyndrickz, MD); University Hospital Saint-Luc, Bruxelles (J. Renkin, MD); Antwerp University, Antwerp (C. Vrints, MD). Canada: Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia (M. Love, MD); Hospital Laval–Quebec Heart-Lung Institute, Ste-Foy (O. Bertrand, MD); Hospital Maisonneuve-Rosemont Polyclinique Research, Montreal, Quebec (C. Constance, MD); Montreal Heart Institute, Montreal, Quebec (J. Tardif, MD); Notre Dame Hospital, Montreal (F. Reeves, MD). France: Purpan University Hospital, Toulouse (J. Puel, MD); Georges Pompidou European Hospital, Paris (A. Lafont, MD); Hôpital Haut Lévèque, Pessac (P. Coste, MD); Institute Jaques Cartier, Massy (M. Morice, MD). Italy: Cardiologia Ospedale Civile, Venezia (B. Reimers, MD); Divisione di Cardiologia Policlinico San Mateo, Pavia (E. Bramucci, MD); Unita di Emodinamica e Cardiologia Interventistica, Milan (A. Colombo, MD); Unità Operativa Distrettuale Cardiologia Invasiva e Emodinamica, Milan (P. Presbitero, MD); Unità Operativa Distrettuale Cardiologia-Laboratorio di Emodinamica, Rome (F. Prati, MD); Unità Operativa Distrettuale Emodinamica Haemodynamic Unit, Siena (A. Bravi, MD); Struttura Operativa Complesso di Cardiologia-Sezione Emodinamica, Udine (G. Bernardi, MD). The Netherlands: Isala Klinieken, Zwolle (M. Grosselink, MD); Onze Lieve Vrouwe Gasthuis Department of Cardiology, Amsterdam (J. Herrman, MD); St Antonius Ziekenhuis–Department of Cardiology, Nieuwegein (B. Rensing, MD). United Kingdom: Edinburgh Royal Infirmary Cardiology Department, Edinburgh, Scotland (N. Uren, MD). Spain: Hospital de Bellvitge, Barcelona (E. Esplugas Oliveras, MD); Hospital Clinic i Provinicial, Barcelona (A. Betriu Gilbert, MD); Hospital Clínico de San Carlos, Madrid (C. Macaya Miguel, MD); Hospital Gregorio Marañón, Madrid (J. Botas Rodriguez, MD); Hospital Universitario de Malaga, Malaga (J. Hernandez Garcia, MD). United States: University of Alabama Hospital, Birmingham (B. Brott, MD); Sutter Medical Center, Santa Rosa, Calif (P. Coleman, MD); University of Colorado Health Sciences Center, Denver (J. Messenger, MD); Littleton Medical Center, Denver, Colo (I. Dauber, MD); Hartford Hospital, Hartford, Conn (P. Thompson, MD); JFK Medical Center, Atlantis, Fla (M. Rothenberg, MD); Rush Medical Center, Chicago, Ill (R. Snell, MD); Iowa Heart Center, Des Moines (M. Ghali, MD); University of Michigan Health System, Ann Arbor (S. Chetcuti, MD); McLaren Regional Medical, Flint, Mich (J. Harris, MD); Cardiac and Vascular Research Center of Northern Michigan, Petoskey (L. Cannon, MD); St Mary Medical Center, Duluth, Minn (A. Deibele, MD); United's John Nasseff Heart Hospital, St Paul, Minn (K. Baran, MD); Buffalo Heart Group, Buffalo, NY (J. Gelormini, MD); Millard Filmore Hospital, Williamsville, NY (J. Corbelli, MD); Moses Cone Health System, Greensboro, NC (B. Brodie, MD); Medical College of Ohio, Toledo (C. Cooper, MD); Geisinger Clinic, Danville, Pa (J. Blankenship, MD); Miriam Hospital, Providence, RI (P. Gordon, MD); Houston Northwest Medical Center, Houston, Tex (B. Lachterman, MD); Aurora Sinai Medical Center, Milwaukee, Wis (Y. Shalev, MD).
Acknowledgment: We thank Nadine Juran, RN, project manager, and Craig Balog, BS, statistician, Cleveland Clinic Cardiovascular Coordinating Center; Helena Melezinkova, MD, AstraZeneca, who monitored adverse events in Europe and Australia and reviewed an earlier version of the manuscript; Joseph Neubauer, AstraZeneca, who provided administrative support of the trial and study supervision; Rohini Chitra, PhD, and Richard Caplan, PhD, AstraZeneca, who provided statistical support in the design of the study; and the Intravascular Ultrasound Core Laboratory staff: Aaron Loyd, William Magyar, Tammy Churchill, Jay Zhitnik, Jordan Andrews, Teresa Fonk, Anne Colagiovanni, Andrea Winkhart, Jessica Fox, Troy Schweitzer, and Paula Shalling.