Key Clinical Research Considerations During the COVID-19 Pandemic: A Trialist’s Perspectives Deepak L. Bhatt, MD, MPH Executive Director of Interventional Cardiovascular Programs, Brigham and Women’s Hospital Heart and Vascular Center Professor of Medicine, Harvard Medical School
Disclosures Dr. Deepak L. Bhatt discloses the following relationships - Advisory Board: Cardax, Cereno Scientific, Elsevier Practice Update Cardiology, LevelEx, Medscape Cardiology, PhaseBio, PLx Pharma, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: 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), Population Health Research Institute; Honoraria: 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), MJH Life Sciences, 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), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR- ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research Funding: 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 Aventis, Synaptic, The Medicines Company; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); Site Co-Investigator: Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), Svelte; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Merck, Novo Nordisk, Takeda. This presentation may include off-label and/or investigational uses of drugs and devices.
COVID-19 An Unintended Force for Medical Revolution? Wang X, Bhatt DL. J Invasive Cardiol 2020;32(4):E81-E82.
Declines in Hospitalizations for CV Conditions During COVID-19: Mass General Brigham Bhatt AS, Moscone A, McElrath EE, Varshney AS, Claggett BL, Bhatt DL, Januzzi JL, Butler J, Adler DS, Solomon SD, Vaduganathan M. JACC 2020. doi: https://doi.org/10.1016/j.jacc.2020.05.038.
Declines in Hospitalizations for CV Conditions During COVID-19: Mass General Brigham Bhatt AS, Moscone A, McElrath EE, Varshney AS, Claggett BL, Bhatt DL, Januzzi JL, Butler J, Adler DS, Solomon SD, Vaduganathan M. JACC 2020. doi: https://doi.org/10.1016/j.jacc.2020.05.038.
Acute Myocardial Injury in Patients Hospitalized with COVID-19 Infection Bavishi C, Bonow RO, Trivedi V, Abbott JD, Messerli FH, Bhatt DL. Progress in Cardiovascular Diseases 2020.
Acute Myocardial Injury in Patients Hospitalized with COVID-19 Infection Bavishi C, Bonow RO, Trivedi V, Abbott JD, Messerli FH, Bhatt DL. Progress in Cardiovascular Diseases 2020.
Meta-Analysis of Patients Hospitalized with COVID-19 – Acute Myocardial Injury in 20%! % Weight Study, Location Prevalence (95% CI) Wu C et al, China 0.05 (0.02, 0.08) 0.05 (0.02, 0.08) 4.22 4.22 Zhou et al, China 0.17 (0.11, 0.23) 0.17 (0.11, 0.23) 3.78 3.78 Wang et al, China 0.07 (0.04, 0.13) 0.07 (0.04, 0.13) 4.05 4.05 Chen C et al, China 0.15 (0.10, 0.21) 0.15 (0.10, 0.21) 3.84 3.84 Shi et al, China 0.20 (0.16, 0.24) 0.20 (0.16, 0.24) 4.12 4.12 Chen T et al, China 0.44 (0.37, 0.51) 0.44 (0.37, 0.51) 3.64 3.64 Guo et al, China 0.28 (0.22, 0.35) 0.28 (0.22, 0.35) 3.71 3.71 Cao et al, China 0.13 (0.06, 0.24) 0.13 (0.06, 0.24) 3.28 3.28 Han et al, China 0.10 (0.07, 0.14) 0.10 (0.07, 0.14) 4.15 4.15 Tu et al, China 0.14 (0.10, 0.20) 0.14 (0.10, 0.20) 3.92 3.92 Du et al, China 0.23 (0.17, 0.30) 0.23 (0.17, 0.30) 3.76 3.76 Wang Y et al, China 0.32 (0.28, 0.37) 0.32 (0.28, 0.37) 3.96 3.96 Deng et al, China 0.38 (0.29, 0.47) 0.38 (0.29, 0.47) 3.25 3.25 Feng et al, China 0.22 (0.19, 0.27) 0.22 (0.19, 0.27) 4.07 4.07 Wang R et al, China 0.07 (0.03, 0.14) 0.07 (0.03, 0.14) 3.86 3.86 Li et al, China 0.22 (0.18, 0.25) 0.22 (0.18, 0.25) 4.16 4.16 Wang L et al, China 0.13 (0.09, 0.19) 0.13 (0.09, 0.19) 4.00 4.00 Richardson et al, US 0.23 (0.21, 0.24) 0.23 (0.21, 0.24) 4.34 4.34 Wei et al, China 0.16 (0.10, 0.24) 0.16 (0.10, 0.24) 3.59 3.59 Li et al, China 0.21 (0.16, 0.28) 0.21 (0.16, 0.28) 3.79 3.79 Ni et al, China 0.28 (0.22, 0.35) 0.28 (0.22, 0.35) 3.68 3.68 Xiong et al, China 0.28 (0.20, 0.39) 0.28 (0.20, 0.39) 3.14 3.14 Shi S et al, China 0.16 (0.13, 0.19) 0.16 (0.13, 0.19) 4.24 4.24 Javanian et al, Iran 0.14 (0.09, 0.22) 0.14 (0.09, 0.22) 3.65 3.65 Shi Q et al, China 0.24 (0.19, 0.29) 0.24 (0.19, 0.29) 3.98 3.98 Yu et al, China 0.27 (0.22, 0.33) 0.27 (0.22, 0.33) 3.82 3.82 Overall pooled prevalence 0.20 (0.17, 0.23) 0.20 (0.17, 0.23) 100.00 100.00 .1 .2 .3 .4 .5 Bavishi C, Bonow RO, Trivedi V, Abbott JD, Messerli FH, Bhatt DL. Progress in Cardiovascular Diseases 2020.
Management of Acute Myocardial Injury in Confirmed or Suspected COVID-19 Chatzizisis YS, Gajanan G, Bhatt DL, Dangas G, Porter T. Atherosclerosis 2020.
Stroke in COVID Patients ≤ 50 Years Annie F, Bates MC, Nanjundappa A, Bhatt DL, Alkhouli M. AJC. 2020
Cardiovascular Trials in the United States Initiated Before and During COVID-19 • Large percentage of trials in states with high COVID-19 burden • Likely will lead to disruption of research • More than a quarter of CV trials were anticipated to complete within 6 months • Heart failure, electrophysiology, and interventional cardiology trials are the most frequent ongoing trials and likely are the most affected Selvaraj S, Greene SJ, Khatana SAM, Nathan AS, Solomon SD, Bhatt DL. JAHA 2020.
The Consequences of the COVID-19 Pandemic on non-COVID-19 Clinical Trials • Hurricane Katrina, 9/11, Ukrainian War, etc. • Horrible, though disruption to research was local, not global • Non-COVID research initiation suspended or de-prioritized • Event rates affected, morbidity and mortality increased • Follow-up visits more challenging, data less complete • Termination of several ongoing trials Bagiella E, Bhatt DL, Gaudino M. JACC 2020. doi: https://doi.org/10.1016/j.jacc.2020.05.041.
Regulation of Cardiovascular Therapies During the COVID-19 Public Health Emergency • Methods to handle increased anticipated data missingness or premature study discontinuation rates • Regional variation in the spread of COVID-19 also introduces unique challenges to the conduct and analysis of global trials • Electronic (as opposed to written) consent • Collection of data even outside of protocol-designated windows Vaduganathan M, Butler J, Krumholz HM, Itchhaporia D, Stecker EC, Bhatt DL. Submitted .
Thank You! Deepak L. Bhatt, MD, MPH Executive Director, Interventional Cardiovascular Programs, BWH Heart & Vascular Center; Professor of Medicine, Harvard Medical School Email: DLBhattMD@post.harvard.edu Twitter: @DLBhattMD www.brighamandwomens.org/heart
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