Investigator-Reported Bleeding Versus Post Hoc Adjudication of Bleeding: Lessons From the CHAMPION PHOENIX Trial

TY - JOUR

T1 - Investigator-Reported Bleeding Versus Post Hoc Adjudication of Bleeding

T2 - Lessons From the CHAMPION PHOENIX Trial

AU - for the CHAMPION PHOENIX Investigators

AU - Jatene, Tannas

AU - Harrington, Robert A.

AU - Stone, Gregg W.

AU - Steg, Ph Gabriel

AU - Gibson, C. Michael

AU - Hamm, Christian W.

AU - Price, Matthew J.

AU - Prats, Jayne

AU - Deliargyris, Efthymios N.

AU - Mahaffey, Kenneth W.

AU - White, Harvey D.

AU - Bhatt, Deepak L.

N1 - Funding Information: Please note: The CHAMPION-PHOENIX trial was funded by The Medicines Company. Dr. Harrington has served on the advisory boards of Evidint, Regado Biosciences, and Scanadu; has received honoraria from Amgen, Daiichi-Sankyo/Lilly, Gilead Sciences, Janssen Research and Development, Medtronic, Merck, Novartis Corporation, The Medicines Company, Vida Health, Vox Media, and WebMD; is affiliated with the American Heart Association; has received research funding from AstraZeneca, Bristol-Myers Squibb, CSL Behring, GlaxoSmithKline, Merck, Portola Pharmaceuticals, Sanofi, The Medicines Company; and has ownership interest in Element Science and MyoKardia. Dr. Steg has received research grants (to INSERM U1148) from Sanofi and Servier; has received speaking or consulting fees from Amarin, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers-Squibb, CSL Behring, Daiichi-Sankyo, GlaxoSmithKline, Janssen Research and Development, Lilly, Novartis, Pfizer, Regeneron, Roche, Sanofi, Servier, and The Medicines Company; and is a stockholder in Aterovax. Dr. Gibson has received research support from Johnson & Johnson, Janssen Research and Development, Bayer, and Portola Pharmaceuticals; and has received consulting fees from The Medicines Company. Dr. Hamm has served as an advisor to The Medicines Company; has received honoraria from AstraZeneca, Sanofi, and Lilly; and has received research funding from AstraZeneca and The Medicines Company. Dr. Price has received honoraria from AstraZeneca, Boston Scientific, Medtronic, Merck, St. Jude Medical, Terumo, and The Medicines Company. Dr. Prats is an employee of The Medicines Company. Dr. Deliagyris is an employee of The Medicines Company. Dr. Mahaffey has received honoraria from American College of Cardiology, Amgen, AstraZeneca, Bayer, BioPrint Fitness, Boehringer Ingelheim, Bristol-Myers-Squibb, Cubist, Eli Lilly, Elsevier, Epson, Forest Laboratories, GlaxoSmithKline, Johnson & Johnson, Medtronic, Merck, Mt. Sinai, MyoKardia, Omthera Pharmaceuticals, Portola Pharmaceuticals, Purdue Pharma, Spring Publishing, The Medicines Company, Vindico, and WebMD; and has received research funding from Daiichi-Sankyo, Johnson & Johnson, Medtronic, St. Jude Medical, and Tenax. Dr. White has received honoraria from AstraZeneca; and has received research funding from Sanofi, Eli Lilly, National Institutes of Health, GlaxoSmithKline, Merck Sharpe & Dohme, AstraZeneca, and Daiichi-Sankyo. Dr. Bhatt has served on the advisory boards of Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, and Regado Biosciences; has served on the board of directors of Boston VA Research Institute and Society of Cardiovascular Patient Care; has served as chair of American Heart Association Get With The Guidelines Steering Committee; has served on the data monitoring committees of Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, and Population Health Research Institute; has received honoraria from American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org), Belvoir Publications (Editor-in-Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), Harvard Clinical Research Institute (clinical trial steering committee), HMP Communications (Editor-in-Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Population Health Research Institute (clinical trial steering committee), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), and WebMD (CME steering committees); has served as the Deputy Editor for Clinical Cardiology; has received research funding from Amarin, AstraZeneca, Bristol-Myers-Squibb, Eisai, Ethicon, Forest Laboratories, Ischemix, Medtronic, Pfizer, Roche, Sanofi, and The Medicines Company (including for his role as co-chair of CHAMPION PHOENIX); has served as site co-investigator for Biotronik and St. Jude Medical; is a trustee of the American College of Cardiology; and has performed unfunded research for FlowCo, PLx Pharma, Takeda. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. We would like to thank Steven E. Elkin, MS, and Debra Bernstein, PhD, of The Medicines Company for their statistical support, along with Yuyin Liu, MS, and Lanyu Lei, MS, of the Harvard Clinical Research Institute for their independent verification of the analyses. Harvard Clinical Research Institute received funding from The Medicines Company for these analyses. A full list of the investigators can be found in Bhatt et al. (1) . (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention [CHAMPION PHOENIX]; NCT01156571 ).

PY - 2016/2/9

Y1 - 2016/2/9

UR - http://www.scopus.com/inward/record.url?scp=84973460174&partnerID=8YFLogxK

U2 - 10.1016/j.jacc.2015.11.027

DO - 10.1016/j.jacc.2015.11.027

M3 - Letter

C2 - 26846956

AN - SCOPUS:84973460174

SN - 0735-1097

VL - 67

SP - 596

EP - 598

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 5

ER -