Accepted for Publication: October 29, 2013.
Published Online: June 18, 2014. doi:10.1001/jamasurg.2014.87.
Study concept and design: Harskamp, Alexander, Lopes.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Harskamp, Schulte, Williams.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Schulte.
Obtained funding: Lopes.
Administrative, technical, or material support: Harskamp, Williams, Schulte.
Study supervision: Alexander, Brophy, Mack, Peterson, Gibson, Kouchoukos, Harrington, Lopes.
Conflict of Interest Disclosures: Dr Alexander has received grants from Bristol-Myers Squibb, Merck, and Regado Biosciences; travel support from Bristol-Myers Squibb; and consulting fees from Bristol-Myers Squibb, Pfizer, Merck, AstraZeneca, Boehringer-Ingelheim, Ortho-McNeil-Janssen Pharmaceuticals, PolyMedix, Regado Biosciences, Bayer, and Daiichi Sankyo. Dr Brophy has received grant 2RO1 HL070715 from the National Institutes of Health (NIH) to study prevention of vein graft spasm and has a financial interest in Vasoprep Inc. Drs Alexander, Williams, and Ferguson are supported in part by grant U01-HL088953 from the NIH Cardiothoracic Surgical Trials Network. Dr Peterson has served as principal investigator of the Data Analytic Center for the American Heart Association Get With the Guidelines; has received research grants from Johnson & Johnson, Eli Lilly, and Janssen Pharmaceuticals; and has served as a consultant to Boehringer Ingelheim, Johnson & Johnson, Medscape, Merck, Novartis, Ortho-McNeil-Janssen, Pfizer, Westat, the Cardiovascular Research Foundation, WebMD, and United Healthcare. Dr Califf reports receiving research funding from the Bristol-Myers Squibb Foundation and Novartis and consulting or other services (including continuing medical education [CME] or other non-CME) from Bayer, Bristol-Myers Squibb Foundation, CV Sight, LLC, DSI-Lilly, Gambro, Heart.org, Janssen R&D, LLC, Kowa, and Novartis. Dr Harrington has received research funding from Abbott Laboratories, Abiomed, Allied Clinical Management Cardiovascular, and Aastrom Biosciences. Dr Lopes has served as a consultant for and is a member of the boards of Boehringer-Ingelheim and Bristol-Myers Squibb and has received grants from AstraZeneca, Boehringer-Ingelheim, and Daiichi Sankyo. No other disclosures were reported.
Funding/Support: This study was supported in part by Somahlution, Inc.
Role of the Sponsor: The funding source had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contribution: Peter Hoffmann, BA, Duke Clinical Research Institute, provided excellent editorial assistance. He did not receive compensation from the sponsor for this role.
Correction: This article was corrected on August 6, 2014, to fix the subtitle.