TY - JOUR
T1 - Randomized Trials in Cardiac Surgery
T2 - JACC Review Topic of the Week
AU - Gaudino, Mario
AU - Kappetein, A. Pieter
AU - Di Franco, Antonino
AU - Bagiella, Emilia
AU - Bhatt, Deepak L.
AU - Boening, Andreas
AU - Charlson, Mary E.
AU - Flather, Marcus
AU - Gelijns, Annetine C.
AU - Grover, Frederick
AU - Head, Stuart J.
AU - Jüni, Peter
AU - Lamy, Andre
AU - Miller, Marissa
AU - Moskowitz, Alan
AU - Reents, Wilko
AU - Shroyer, A. Laurie
AU - Taggart, David P.
AU - Tam, Derrick Y.
AU - Zenati, Marco A.
AU - Fremes, Stephen E.
N1 - Funding Information:
Dr. Kappetein is an employee of Medtronic. Dr. Bhatt has served on the Advisory Board of Cardax, Cereno Scientific, Elsevier Practice Update Cardiology, Medscape Cardiology, PhaseBio, PLx Pharma, and Regado Biosciences; has served on the Board of Directors of Boston VA Research Institute, Society of Cardiovascular Patient Care, and TobeSoft; has served as chair of the American Heart Association Quality Oversight Committee, NCDR-ACTION Registry Steering Committee, and VA CART Research and Publications Committee; has served on Data Monitoring Committees for Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi-Sankyo), and the Population Health Research Institute; has received honoraria from the American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice-Chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor-in-Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor-in-Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Medtelligence/ReachMD (CME steering committees), Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today's Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), and WebMD (CME steering committees); has served as Deputy Editor of Clinical Cardiology; has received research funding from Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lexicon, Lilly, Medtronic, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, Sanofi, Synaptic, and The Medicines Company; has received royalties from Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald's Heart Disease); has served as site co-investigator for Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), and Svelte; is a Trustee of the American College of Cardiology; and has performed unfunded research for FlowCo, Merck, Novo Nordisk, and Takeda. Dr. Grover has served as a consultant for, received travel reimbursement for Data Safety Monitoring Committees from, and received honoraria from Jena Valve, Boston Scientific, and Polares Medical. Dr. Head is a full-time employee of Medtronic outside the scope of this work. Dr. Jüni is a Tier 1 Canada Research Chair in Clinical Epidemiology of Chronic Diseases; has served as an unpaid member of the steering group of trials funded by AstraZeneca, Biotronik, Biosensors, St. Jude Medical, and The Medicines Company; has received research grants to his institution from AstraZeneca, Biotronik, Biosensors International, Eli Lilly, and The Medicines Company; and has received honoraria to his institution for participation in advisory boards and/or consulting from Amgen, Ava, and Fresenius, but has not received personal payments by any pharmaceutical company or device manufacturer. Dr. Tam is supported by a CIHR Fellowship. Dr. Fremes is supported in part by the Bernard S. Goldman Chair in Cardiovascular surgery. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Danny Ramzy, MD, PhD, has served as Guest Associate Editor for this paper.
Publisher Copyright:
© 2020 American College of Cardiology Foundation
PY - 2020/4/7
Y1 - 2020/4/7
N2 - Compared with randomized controlled trials (RCTs) in medical specialties, RCTs in cardiac surgery face specific issues. Individual and collective equipoise, rapid evolution of the surgical techniques, as well as difficulties in obtaining funding, and limited education in clinical epidemiology in the surgical community are among the most important challenges in the design phase of the trial. Use of complex interventions and learning curve effect, differences in individual operators’ expertise, difficulties in blinding, and slow recruitment make the successful completion of cardiac surgery RCTs particularly challenging. In fact, over the course of the last 20 years, the number of cardiac surgery RCTs has declined significantly. In this review, a team of surgeons, trialists, and epidemiologists discusses the most important challenges faced by RCTs in cardiac surgery and provides a list of suggestions for the successful design and completion of cardiac surgery RCTs.
AB - Compared with randomized controlled trials (RCTs) in medical specialties, RCTs in cardiac surgery face specific issues. Individual and collective equipoise, rapid evolution of the surgical techniques, as well as difficulties in obtaining funding, and limited education in clinical epidemiology in the surgical community are among the most important challenges in the design phase of the trial. Use of complex interventions and learning curve effect, differences in individual operators’ expertise, difficulties in blinding, and slow recruitment make the successful completion of cardiac surgery RCTs particularly challenging. In fact, over the course of the last 20 years, the number of cardiac surgery RCTs has declined significantly. In this review, a team of surgeons, trialists, and epidemiologists discusses the most important challenges faced by RCTs in cardiac surgery and provides a list of suggestions for the successful design and completion of cardiac surgery RCTs.
KW - RCT
KW - cardiac surgery
KW - randomized controlled trials
UR - http://www.scopus.com/inward/record.url?scp=85082028734&partnerID=8YFLogxK
U2 - 10.1016/j.jacc.2020.01.048
DO - 10.1016/j.jacc.2020.01.048
M3 - Review article
C2 - 32241376
AN - SCOPUS:85082028734
SN - 0735-1097
VL - 75
SP - 1593
EP - 1604
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 13
ER -