Published Online: September 3, 2013. doi:10.1001/jama.2013.277169.
Study concept and design: Nicholls, Menon, Williams, Armbrecht, Fang, Bash, Nissen.
Acquisition of data: Nicholls, Bakris, Armbrecht, Brunel, Nicolaides, Puri, Nissen.
Analysis and interpretation of data: Nicholls, Bakris, Kastelein, Menon, Williams, Armbrecht, Brunel, Nicolaides, Hsu, Hu, Fang, Puri, Uno, Kataoka, Nissen.
Drafting of the manuscript: Nicholls, Bakris, Menon, Armbrecht, Puri, Uno, Bash, Nissen.
Critical revision of the manuscript for important intellectual content: Bakris, Kastelein, Menon, Williams, Armbrecht, Brunel, Nicolaides, Hsu, Hu, Fang, Puri, Kataoka, Nissen.
Statistical analysis: Hsu, Hu, Fang, Nissen.
Obtained funding: Nicholls, Armbrecht, Nissen.
Administrative, technical, or material support: Nicholls, Bakris, Kastelein, Menon, Williams, Armbrecht, Brunel, Nicolaides, Uno, Bash, Nissen.
Study supervision: Nicholls, Kastelein, Menon, Williams, Armbrecht, Brunel, Nicolaides, Nissen.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. The study was sponsored by Novartis Pharmaceuticals. Dr Nicholls reported receiving research support from AstraZeneca, Novartis, Eli Lilly, Anthera, LipoScience, Roche, and Resverlogix; and receiving honoraria from or serving as a consultant to AstraZeneca, Roche, Esperion, Abbott, Pfizer, Merck, Takeda, LipoScience, Omthera, Novo-Nordisk, sanofi-aventis, Atheronova, Anthera, CSL Behring, and Boehringer Ingelheim. Dr Bakris reported serving as a consultant to Novartis, Daichi-Sankyo, Boehringer Ingelheim, Takeda, AbbVie, Medtronic, Relypsa, Gilead, Concert; receiving investigator-initiated grant funding from Takeda; and serving as the editor of the hypertension section of Up-To-Date and as editor of the American Journal of Nephrology. Dr Kastelein reported serving as a consultant to Novartis. Dr Menon reported receiving support for travel from Novartis for AQUARIUS trial meetings. Dr Williams reported receiving honoraria from Novartis, Boehringer Ingelheim, Pfizer, Servier, and Daichi Sankyo; and receiving support from the National Institute for Health Research University College London Hospitals Biomedical Research Centre. Drs Armbrecht, Brunel, Nicolaides, and Fang are employees of Novartis Pharma AG and are thus eligible for Novartis stock and stock options. Dr Nissen reported receiving research support from Amgen, AstraZeneca, Eli Lilly, Orexigen, Vivus, Novo Nordisk, Resverlogix, Novartis, Pfizer, Takeda, Sankyo, and sanofi-aventis; serving as a consultant for a number of pharmaceutical companies without financial compensation because all honoraria, consulting fees, or any other payments from any for-profit entity are paid directly to charity so that neither income nor any tax deduction is received. No other author reported disclosures.
Funding/Support: The study was funded by Novartis Pharmaceuticals.
Role of the Sponsor: Novartits Pharmaceuticals participated actively in designing the study, developing the protocol, and providing logistical support during the trial. Monitoring of the study was performed by the sponsor. The sponsor maintained the trial database. The results reported in this article are the results of the analyses performed by Ms Hsu and Dr Hu. The sponsor was permitted to review the manuscript and suggest changes, but the final decision on content was exclusively retained by the academic authors. Although the steering committee and coordinating center had confidentiality agreements with the sponsor, the study contract specified that a copy of the study database be provided to the coordinating center for independent analysis and granted the academic authors the unrestricted rights to publish the results.
Independent Statistical Analysis: After completion of the trial, as specified in the study contract, a complete copy of the database was transferred to the Cleveland Clinic Coordinating Center for Clinical Research, where analyses were verified by independent academic statisticians (Ms Hsu and Dr Hu).
Data and Safety Monitoring Board: Carl Pepine (chair), William Cushman, Peter Ganz, Kerry Lee, James Pool.
Intravascular Ultrasound Core Laboratory Staff: William Magyar, BS, Jordan Andrews, BS, Eva Balazs, BS, Anne Colagiovanni, BS, Teresa Fonk, BS, Karilane King, BS, Erin Mayock, BS, Roman Poliszczuk, BS, Rhiannon Regal, BS, Jill Rusticelli.
Investigators: Argentina: G. Migliaro and C. Majul (Hospital Britanico de Buenos Aires); A. Damonte (Instituto Cardiovascular de Rosario); P. Kantor (Sanatorio Dupuytren); E. Farias (Instituto de Cardiologia J. F. Cabral); A. Salvatierra Ruiz (Sanatorio Mitre); A. Pocovi (Instituto Alexander Fleming); A. Villamil (Instituto Cardiovascular de Buenos Aires). Australia: J. Cameron (Monash Medical Centre); S. Worthley (Royal Adelaide Hospital); N. Collins (John Hunter Hospital); C. Juergens (Liverpool Hospital). Belgium: J. Renkin (Cliniques Universitaires Saint-Luc); M. Vrolix (Ziekenhuis Oost Limburg); J. Lalmand (Centre Hospitaliere Universitaire); B. De Bruyne (OLV Zh); S. Vercauteren (Kliniek Sint-Jan); M. Goldstein (Clinique Sainte-Anne-Saint-Remi); J. Debrauwere (ASZ Aalst). Canada: J. Burton (University of Alberta Hospital); T. Cieza (CSSS de Chicoutimi); C. Constance (Hopital Maisonneuve-Rosemont); W. Hui (Royal Alexandra Hospitals); S. Lavi (London Health Sciences Center); J-C. Tardif (Montreal Heart Institute); J. Rodes Cabau (Quebec Heart Institute). France: C. Caussin (Hopital Marie Lannelongue); P. Coste (Hopital Cardiologique du Haut); E. Teiger (Hopital Henri Mondor); M. Elbaz (Hopital de Rangueil). Germany: R. Erbel (Universitaetsklinikum Essen); S. Baldus (Universitaetsklinikum Hamburg-Eppendorf); S. Moebius-Winkler (Herzzentrum Leipzig); H. Mudra (Stadtisches Klinikum Munchen GmbH); M. Bergmann (Asklepios Klinik St. Georg); J. Haase (Kardiocentrum Frankfurt an der Klinik). Hungary: R. Kiss (Magyar Honvedseg Honved Korhaz); B. Merkely (SOTE Kardiologiai Centrum); I. Ungi (Szegedi Tudomanyegeyetem Alt Orvo); I. Horvath (Pecsi Tudomanyegeyetem AOK); I. Edes (DEOEC). Italy: A. Colombo (Ospedale San Raffaele); G. Musumeci (Azienda Ospedaliera-Ospedali Riunit di Bergamo); M. Fineschi (A O Universitaria Senese); L. Viignali (Az Ospedaliero Universitaria di Parma); P. Presbitero (IRCCS Istituto Clinico Humanitas); S. Berti (Osperdale del Cuore); F. Prati (Azeienda Ospedaliera S. Giovanni-Addolorata); G. De Luca (Az. Osp. Univ. Maggiore della Carita); F. Airoldi (Policlinico Multimedica Universita degli Studi). Poland: J. Grzybowski (Insytut Kardiologii Im Prymasa); A. Lubinski (Uniwerstyecki Szpital Kliniczny); L. Bryniarski (Szpital Uniwersytecki w Krakowie); S. Dobrzycki (Uniwersytecki Szpital Kliniczny). Spain: F. Alfonso (Hospital Clinico San Carlos); J. Angel Ferrer (Hospital Vall D’Hebron); A. Cequier (H. Univesitari de Bellvitge); J. Zueco Gil (Hospital Universitario Marques de Valdecilla); J. Maria Hernandez (Hospital Virgen de la Victoria); A. Iniguez (Hospital Meixoeiro); C. Suarez (Hospital General de Asturias); R. Moreno (Hospital La Paz); J. Goicolea (Hospital Puerta de Hierro); A. Serra (Hospital del Mar); R. Rumoroso (Hospital de Galgakano). United States: J. Feldman (Katy Cardiology Associates); W. Herzog (Johns Hopkins University); M. Holland (Boulder Medical Center); V. Howard (VNH Heart Center Research); W. Jauch (Pasco Cardiology Center); M. Krolick (Heart and Vascular Center); G. Lasala (TCA Research); W. Leimbach (Hillcrest Healthcare System); M. Kumar Sharma (Parkway Cardiology Associates); R. Waksman (Washington Hospital Center); R. Webel (University of Missouri Health Care); S. Smith (Mountain States Health Alliance); J. Whitaker (Mountain States Health Alliance); R. Matthews (University of Southern California); M. Yasin (Integris Physician Services); W. Penny (San Diego Veterans Medical Center); K. Mavromatis (Atlanta VA Medical Center); S. Promisloff (Hillsboro Cardiology); M. Azrin (University of Connecticut Health Center); A-U-R. Zaki Masud (Buffalo Heart Group); J. Corbelli (Buffalo Cardiology and Pulmonary Associates); L. Kozlowski (Buffalo Cardiology and Pulmonary Associates); R. Vallabhan (HeartPlace/Baylor University Medical Center); J. Battaglia (Cardiology PC); M. Sheldon (University of New Mexico Health Sciences Center); M. Riccardi, V. Gupta (Borgess Heart Institute-Borgess Research Institute); W. Felten (Michigan Cardiovascular Institute); H. Colfer (Northern Michigan Hospital); F. D. Fortuin (Mayo Clinic Arizona); M. Feldman (University of Texas Health Sciences Center at San Antonio); L. Lancaster (Pima Research Foundation); H. Thai (Southern Arizona VA Healthcare System); K. Ziada (Gill Heart Institute); J. Mann (Wake Heart Research); M. Budoff (University of California Los Angeles); D. Westerhausen (Midwest Cardiovascular Research); K. Ramanathan (VA Medical Center Memphis); T. Haldis (Meritcare Medical Group); S. Kinlay (VA Boston Healthcare System).
Additional Contributions: We thank Craig Balog, BS, for research statistical support and Leslie Cho, MD, as well as all of the staff in the event adjudication group at the Cleveland Clinic Coordinating Center for Clinical Research. We also thank Beverley Smith, RN, Robin Roberts, MS, Satya Konkesa, MS, and Edna Cahill, MS, at Novartis for their role in study coordination. There was no additional compensation for their contributions beyond their usual compensation as employees.