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Valvular Heart Disease

Enrollment of Older Patients, Women, and Racial and Ethnic Minority Individuals in Valvular Heart Disease Clinical TrialsA Systematic Review

To identify the key insights or developments described in this article

1 Credit CME

JAMA Cardiology

Published Online: July 26, 2023

Review

Article Information and Disclosures

Kriyana P. Reddy, BS¹;

Michela Faggioni, MD²;

Lauren A. Eberly, MD, MPH^1,2;

Rim Halaby, MD²;

Monika Sanghavi, MD²;

Jennifer Lewey, MD, MPH²;

Roxana Mehran, MD^3,7;

Megan Coylewright, MD, MPH⁴;

Howard C. Herrmann, MD²;

Jay Giri, MD, MPH^1,2,5,6;

Alexander C. Fanaroff, MD, MHS^1,2,6;

Ashwin S. Nathan, MD, MS^1,2,5,6

Author Affiliations

¹Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center, University of Pennsylvania, Philadelphia
²Division of Cardiology, Hospital of the University of Pennsylvania, Philadelphia
³Icahn School of Medicine at Mount Sinai, New York, New York
⁴Erlanger Health System, Chattanooga, Tennessee
⁵Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania
⁶Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania
⁷Associate Editor, JAMA Cardiology

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Key Points

Question How representative are contemporary valvular heart disease trials with respect to age, sex, race, and ethnicity?

Findings In this systematic review of valvular heart disease clinical trials, the weighted mean (SD) age of trial participants was 68.4 (11.4) years, women comprised 41% of the overall trial population, and there were few trials that reported data on race and ethnicity. There were no significant increases in the representation of older patients, women, and racial and ethnic minority groups over time.

Meaning Women and racial and ethnic minority individuals remain underrepresented in North American valvular heart disease clinical trials with few trials reporting data on the race and ethnicity of trial participants.

Abstract

Importance Inadequate representation of older patients, women, and racial minority individuals in cardiovascular clinical trials limits both the generalizability of trial findings and inclusivity in access to novel therapies and therapeutic strategies.

Objective To report on temporal trends in the representation of older patients, women, and racial and ethnic minority individuals in clinical trials studying treatments for valvular heart disease.

Evidence Review All published clinical trials enrolling more than 100 adults with any valvular heart disease published between 2005 and 2020 were included after searches with PubMed and ClinicalTrials.gov. Data on age, sex, race, and ethnicity reported in the included studies were collected. Trials were assigned to 4 time periods based on the publication date, and temporal trends were analyzed in the representation of older patients, women, and racial and ethnic minority individuals.

Findings A total of 139 clinical trials with 51 527 participants were identified. Of these trials, 103 (74%) investigated aortic valve disease and the remainder mitral valve disease. Overall, 63 trials (45.3%) enrolled patients only in Europe, 24 (17.3%) only in North America, and 19 (13.7%) in multiple geographical regions. The weighted mean (SD) age of enrolled patients was 68.4 (11.4) years, increasing nonsignificantly from 61.9 (5.9) years in 2005-2008 to 72.8 (9.6) years in 2017-2020 (P = .09 for trend). The overall proportion of women enrolled in valvular heart disease trials was 41.1%, with no significant changes over time. Data on race and ethnicity of trial participants were reported in 13 trials (9.4%), in which trial-level representation of American Indian/Alaska Native, Asian, Black/African American, Hispanic, and Native Hawaiian/Pacific Islander patients ranged from 0.27% to 43.9%. There were no significant temporal trends noted in the enrollment of racial and ethnic minority populations. The representation of women in clinical trials was positively associated with enrollment rates of older patients and underrepresented racial and ethnic groups.

Conclusions and Relevance This review found that over the past 2 decades, women and racial and ethnic minority individuals have remained underrepresented in North American valvular heart disease clinical trials. Further work is needed to improve the reporting of race and ethnicity data and address barriers to trial enrollment for older patients, women, and racial and ethnic minority individuals.

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Article Information

Accepted for Publication: April 7, 2023.

Published Online: July 26, 2023. doi:10.1001/jamacardio.2023.2098

Corresponding Author: Kriyana P. Reddy, BS, Penn Cardiovascular Outcomes, Quality, and Evaluative Research Center, University of Pennsylvania, 423 Guardian Dr, 12th Floor Blockley Hall, Philadelphia, PA 19104 (kriyana_reddy@alumni.brown.edu).

Author Contributions: Ms Reddy and Dr Faggioni had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Ms Reddy and Dr Faggioni contributed equally as co–first authors.

Concept and design: Reddy, Faggioni, Eberly, Mehran, Herrmann, Giri, Fanaroff, Nathan.

Acquisition, analysis, or interpretation of data: Reddy, Faggioni, Halaby, Sanghavi, Lewey, Coylewright, Fanaroff.

Drafting of the manuscript: Reddy, Faggioni.

Critical revision of the manuscript for important intellectual content: Reddy, Eberly, Halaby, Sanghavi, Lewey, Mehran, Coylewright, Herrmann, Giri, Fanaroff, Nathan.

Statistical analysis: Reddy, Giri.

Obtained funding: Giri.

Administrative, technical, or material support: Giri.

Supervision: Faggioni, Eberly, Lewey, Giri, Nathan.

Conflict of Interest Disclosures: Dr Mehran reported grants from Abbott, Abiomed, Alleviant Medical, Amgen, AM-Pharma, Arena, AstraZeneca, AtriCure, Bayer, Biosensors, Biotronik, Boston Scientific, Bristol Myers Squibb, CardiaWave, CeloNova, Chiesi, Concept Medical, CSL Behring, Cytosorbents, Daiichi Sankyo, Element Science, Faraday, Filterlex Medical, Humacyte, Idorsia, Janssen, Magenta, Mediasphere, Medtelligence, Medtronic, Novartis, OrbusNeich, Penumbra, PhaseBio, Philips, Pi-Cardia, Plx Pharma, Protembis, RenalPro, RM Global, Shockwave, Vivasure, and Zoll; personal fees from Cine-Med Research, Ionis Pharmaceuticals, Novartis, Novo Nordisk, Vectura, and WebMD; equity (<1%) in Applied Therapeutics, Elixir Medical, Stel, and ControlRad (spouse) outside the submitted work; and serving as board and/or committee members for the American Medical Association, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, and Cardivascular Research Foundation. Dr Coylewright reported grants from Edwards LifeSciences and personal fees from Boston Scientific, Edwards LifeSciences, Occlutech, and Medtronic outside the submitted work and leading the eligibility review committee for EXPAND TAVR II (Medtronic). Dr Herrmann reported grants from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Highlife, and Medtronic and personal fees from Medtronic during the conduct of the study. Dr Giri reported grants from Inari Medical, Boston Scientific, Abiomed, Recor Medical, and Biosense Webster and personal fees from Abbott Vascular, Inari Medical, and Boston Scientific outside the submitted work. Dr Fanaroff reported grants from American Heart Association and Cardiovascular Systems outside the submitted work. Dr Nathan reports institutional research funding from Abiomed and Biosense Webster and speaker fees from Abiomed. No other disclosures were reported.

AMA CME Accreditation Information

Credit Designation Statement: The American Medical Association designates this Journal-based CME activity activity for a maximum of 1.00  AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to:

1.00 Medical Knowledge MOC points in the American Board of Internal Medicine's (ABIM) Maintenance of Certification (MOC) program;;
1.00 Self-Assessment points in the American Board of Otolaryngology – Head and Neck Surgery’s (ABOHNS) Continuing Certification program;
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1.00 Lifelong Learning points in the American Board of Pathology’s (ABPath) Continuing Certification program; and
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