Author Contributions: Dr Alexander 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: Alexander, Harrington, Ferguson, Lorenz, Mack, Gennevois, Califf.
Acquisition of data: Alexander, Harrington, Ferguson, Lorenz, Goyal, Gibson, Gennevois, Califf.
Analysis and interpretation of data: Alexander, Hafley, Harrington, Peterson, Lorenz, Goyal, Gibson, Mack, Gennevois, Califf, Kouchoukos.
Drafting of the manuscript: Alexander, Hafley, Ferguson, Gibson.
Critical revision of the manuscript for important intellectual content: Alexander, Harrington, Peterson, Ferguson, Lorenz, Goyal, Mack, Gennevois, Califf, Kouchoukos.
Statistical analysis: Hafley, Lorenz.
Obtained funding: Alexander, Harrington, Peterson, Ferguson, Lorenz, Gennevois, Califf.
Administrative, technical, or material support: Alexander, Harrington, Lorenz, Gibson, Goyal, Gennevois, Califf, Kouchoukos.
Study supervision: Alexander, Harrington, Ferguson, Lorenz, Mack, Califf.
Financial Disclosures: Drs Alexander, Harrington, Peterson, Gibson, and Califf have received research funding from Corgentech Inc. Dr Gennevois is an employee of Corgentech. Dr Lorenz is a former employee of Corgentech and retains significant equity ownership.
Funding/Support: The PREVENT IV Trial was funded by Corgentech Inc (South San Francisco, Calif).
Role of the Sponsor: Representatives of Corgentech Inc served on the steering committee and were involved in the design and conduct of the study and in the management of data collection. They reviewed and commented on the manuscript; however, they were not directly responsible for the analysis or interpretation of the data presented in the manuscript, the preparation of the manuscript, or the final approval of the manuscript.
Investigators of PREVENT IV: F. S. Malik, MD, Charleston Area Medical Center; N. Baumgartner, MD, Michigan Cardiovascular Institute; D. Duncan, MD, Forsyth Medical Center; B. Mindich, MD, the Valley Hospital; M. J. Mack, MD, Medical City Dallas Hospital; S. Roberts, MD, Genesis Heart Institute; T. Kroshus, MD, PhD, Minneapolis Cardiothoracic Surgery; A. Zacharias, MD, Saint Vincent Mercy Medical Center; T. E. Theman, MD, St Luke’s Hospital; C. D. Randleman, Jr, MD, Baptist Medical Center, Montclair; N. Kouchoukos, MD, Missouri Baptist Hospital; J. Todd, MD, Peninsula Regional Medical Center; M. Malias, MD, Holmes Regional Medical Center; P. Wickstrom, MD, Saint Mary’s/Duluth Clinic Health System; R. Novoa, MD, Aultman Hospital/Canton Cardiovascular; K. Accola, MD, Florida Hospital; J. C. Laschinger, MD, St Joseph’s Medical Center; M. Platt, MD, Presbyterian Hospital of Dallas; R. Rouse, MD, South Texas Cardiothoracic & Vascular; B. Sun, MD, Ohio State University Medical Center; C. Milano, MD, Duke University Medical Center; K. R. Petro, MD, Washington Hospital Center; L. Suarez, MD, Appleton Cardiology Associates & Heart Institute; D. Gangahar, MD, Nebraska Medical Center; R. Dowling, MD, Jewish Hospital-Louisville; A. Schwartz, MD, Shawnee Mission Medical Center; J. Johnkoski, MD, Wausau Hospital; A. Kiser, MD, First Health Moore Regional Hospital; M. Sand, MD, Orlando Heart Center; Z. Davis, MD, Edward Hospital; J. Schwartz, MD, Loyola University Medical Center; T. Acuff, MD, Denton Regional Medical Center; G. Roth, MD, Ingham Regional Medical Center; K. Allen, MD, the Heart Center of Indiana; T. Militano, MD, Washington Adventist Hospital; C. J. Magovern, MD, Morristown Memorial Hospital; E. Zech, MD, Saint Joseph Hospital; M. Beggs, MD, Sarasota Memorial Hospital; O. M. Lattouf, MD, Emory University Hospital; P. Cho, MD, Sinai Hospital of Baltimore; M. W. Gerdisch, MD, Central DuPage Hospital; A. Yap, MD, Seton Medical Center; J. L. Harlan, MD, Medical Center East; J. M. Graham, MD, Saint Johns Regional Medical Center; W. Pae, Jr, MD, Hershey Medical Center; S. F. Aranki, MD, Brigham and Women’s Hospital; M. McDonald, MD, St Luke’s Medical Center/Midwest Heart Surgery Institute; R. Kamienski, MD, Akron General Medical Center; R. S. Kramer, MD, Maine Medical Center; E. Zias, MD, Westchester Medical Center; J. Michael DiMaio, MD, UT Southwestern Medical Center of Dallas; J. Stringham, MD, University of Utah Hospital; D. A. DeBoer, MD, Northern Illinois Cardiovascular & Thoracic; P. Horneffer, MD, Saint Joseph Medical Center; R. Hooker, Jr, MD, West Michigan Cardiovascular Surgeons; V. Subramanian, MD, Lenox Hill Hospital; J. Everett, MD, University of Iowa College of Medicine; R. J. Robbins, MD, Forrest General Hospital; D. Frantz, MD, Lynchburg Cardiothoracic Surgery; J. Richardson, Jr, MD, Brookwood Medical Center; N. Zama, MD, Southern Illinois University School of Medicine; T. Dorheim, MD, Nebraska Methodist Hospital; R. Hagberg, MD, Sentara Norfolk General Hospital; P. E. Seifert, MD, Waukesha Memorial Hospital; C. Wright, MD, Greenville Memorial Hospital; J. Frederiksen, MD, Northwestern University; J. Michael Smith, MD, Good Samaritan Hospital; M. Anderson, MD, Robert Wood Johnson Medical School; C. Dyke, MD, the Sanger Clinic; B. C. Sheridan, MD, University of North Carolina at Chapel Hill; D. Rose, MD, Saint Vincents Medical Center; J. Quin, MD, Southern Illinois University School of Medicine; L. Hiratzka, MD, Bethesda North Hospital; M. Felger, MD, Heart Hospital of Austin; B. E. Vazales, MD, Northern Michigan Hospital; R. Murbach, MD, Morton Plant Hospital; W. Randolph Chitwood, MD, East Carolina University; A. Zacharias, MD, St Luke’s Hospital; R. Engelman, MD, Baystate Medical Center; R. F. Schneider, Jr, MD, Iowa Methodist Medical Center; J. Magovern, MD, Allegheny General Hospital; M. Goldin, MD, Rush-Presbyterian-St Luke’s Medical Center; T. Spooner, MD, Park Nicollet Heart Center; D. Mueller, MD, Illinois Cardiac Surgery Associates; F. R. Armenti, MD, McLaren Regional Hospital; J. R. Edgerton, MD, Banner Baywood Hospital; P. Pavlina, MD, Kettering Medical Center; S. R. Hazelrigg, MD, Southern Illinois University School of Medicine; V. Disesa, MD, Chester County Hospital; F. Ferdinand, MD, Lankenau Hospital; S. Gundry, MD, Desert Regional Medical Center; Y. Naka, MD, Columbia Presbyterian Medical Center; B. Daily, MD, St Elizabeth’s Hospital/Memorial Hospital; D. Torchiana, MD, Massachusetts General Hospital; G. Blossom, MD, Riverside Methodist Hospital; J. Brown, MD, University of Maryland; D. Vega, MD, Emory University Hospital; J. E. Bavaria, MD, Hospital of the University of Pennsylvania; P. K. Shah, MD, Cedar-Sinai Medical Center; T. Rosengart, MD, Highland Park Hospital; J. Conte, MD, John Hopkins University Medical Center; J. N. Young, MD, UC-Davis Medical Center.
PREVENT IV Steering Committee: R. M. Califf (cochair), Duke University Medical Center, Durham, NC; N. T. Kouchoukos (cochair), Missouri Baptist Medical Center, St Louis; J. H. Alexander (principal investigator), Duke University Medical Center, Durham, NC; T. B. Ferguson, Louisiana State University, New Orleans; M. J. Mack, Cardiopulmonary Research, Science and Technology Institute, Dallas, Tex; C. M. Gibson, PERFUSE Angiographic Core Laboratory, Boston, Mass; R. K. Wolf, University of Cincinnati, Cincinnati, Ohio; K. L. Lee, Duke Clinical Research Institute, Durham, NC; D. Gennevois, Corgentech Inc, South San Francisco, Calif; T. J. Lorenz, Corgentech Inc, South San Francisco, Calif; R. A. Harrington, Duke University Medical Center, Durham, NC; E. D. Peterson, Duke University Medical Center, Durham, NC; J. B. Putnam, Jr, Vanderbilt University Medical Center, Nashville, Tenn; L. H. Cohen, Brigham and Women’s Hospital, Boston, Mass.
PREVENT IV Data and Safety Monitoring Board: G. Kaiser (chair), Webster Grove, Mo; R. Anderson, Virginia Mason Medical Center, Seattle, Wash; C. Cannon, Brigham and Women’s Hospital, Boston, Mass; J. Tcheng, Duke University Medical Center, Durham, NC; B. Tsiatis, North Carolina State University, Raleigh.
Acknowledgment: We thank Gail Hafley, MS, and Rakhi Kilaru, MS, for statistical support and Vivian McGee, MTSc, for editorial assistance with the manuscript (all are with the Duke Clinical Research Institute, Durham, NC, and had a portion of their Duke University salaries indirectly covered by funding from Corgentech). Hamid Namini, PhD (Corgentech, South San Francisco, Calif) was instrumental in the design and analysis of PREVENT IV. We also thank Kenneth Mahaffey, MD, and June Wampole, RN (both are with the Clinical Events Committee, Duke Clinical Research Institute, Durham, NC, and had a portion of their Duke University salaries indirectly covered by funding from Corgentech); Jackie Buros, BS (PERFUSE Angiographic Core Laboratory, Boston, Mass, and had a portion of her salary indirectly covered by funding from Corgentech); and Mary Eiken, RN (Society of Thoracic Surgeons, Chicago, Ill) for their contributions to PREVENT IV.