Range and Consistency of Cardiovascular Outcomes Reported by Clinical Trials in Kidney Transplant Recipients: A Systematic Review

Gregory J. Wilson, MBBS; Kim Van, MBBS; Emma O’Lone, PhD; Allison Tong, PhD; Jonathan C. Craig, PhD; Benedicte Sautenet, PhD; Klemens Budde, MD; Derek Forfang; John Gill, MD; William G. Herrington, MD; Tazeen H. Jafar, MPH; David W. Johnson, PhD; Vera Krane, MD; Adeera Levin, MD; Jolanta Malyszko, PhD; Patrick Rossignol, PhD; Deirdre Sawinski, MD; Nicole Scholes-Robertons, PhD; Giovanni Strippoli, PhD; Angela Wang, PhD; Wolfgang C. Winkelmayer, MD; Carmel M. Hawley, MMedSci; Andrea K. Viecelli, PhD

doi:10.1097/TXD.0000000000001398

Transplantation Direct (Jan 2023)

Range and Consistency of Cardiovascular Outcomes Reported by Clinical Trials in Kidney Transplant Recipients: A Systematic Review

Gregory J. Wilson, MBBS,
Kim Van, MBBS,
Emma O’Lone, PhD,
Allison Tong, PhD,
Jonathan C. Craig, PhD,
Benedicte Sautenet, PhD,
Klemens Budde, MD,
Derek Forfang,
John Gill, MD,
William G. Herrington, MD,
Tazeen H. Jafar, MPH,
David W. Johnson, PhD,
Vera Krane, MD,
Adeera Levin, MD,
Jolanta Malyszko, PhD,
Patrick Rossignol, PhD,
Deirdre Sawinski, MD,
Nicole Scholes-Robertons, PhD,
Giovanni Strippoli, PhD,
Angela Wang, PhD,
Wolfgang C. Winkelmayer, MD,
Carmel M. Hawley, MMedSci,
Andrea K. Viecelli, PhD

Affiliations

Gregory J. Wilson, MBBS: 1 Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.
Kim Van, MBBS: 4 Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Emma O’Lone, PhD: 4 Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Allison Tong, PhD: 4 Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
Jonathan C. Craig, PhD: 5 College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Benedicte Sautenet, PhD: 6 Service de Nephrologie-Hypertension, Dialyses, Transplantation Rénale, Hopital Bretonneau, Université de Tours, Université de Nantes, INSERM SPHERE U 1246, Tours, France.
Klemens Budde, MD: 7 Charité Universitätsmedizin Berlin, Berlin, Germany.
Derek Forfang: 8 National Kidney Foundation, New York, NY.
John Gill, MD: 9 University of British Columbia, Vancouver, BC, Canada.
William G. Herrington, MD: 10 Nuffield Department of Population Health, Medical Research Council Population Health Research Unit at the University of Oxford, Oxford, United Kingdom.
Tazeen H. Jafar, MPH: 11 Duke – NUS Medical School, Singapore, Singapore.
David W. Johnson, PhD: 1 Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.
Vera Krane, MD: 12 University of Würzburg, Würzburg, Germany.
Adeera Levin, MD: 13 University of British Columbia, Vancouver, BC, Canada.
Jolanta Malyszko, PhD: 14 Department of Medicine, Division of Nephrology, University of Wurzburg, Wurzburg, Germany.
Patrick Rossignol, PhD: 15 Université de Lorraine & FCRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists) Network, Nancy, France.
Deirdre Sawinski, MD: 16 Weill Cornell Medical College, New York, NY.
Nicole Scholes-Robertons, PhD: 17 The University of Sydney, Sydney, NSW, Australia.
Giovanni Strippoli, PhD: 18 University of Bari, Bari, Italy.
Angela Wang, PhD: 19 The University of Hong Kong, Pok Fu Lam, Hong Kong.
Wolfgang C. Winkelmayer, MD: 20 Baylor College of Medicine, Houston, TX.
Carmel M. Hawley, MMedSci: 1 Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.
Andrea K. Viecelli, PhD: 1 Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.

DOI: https://doi.org/10.1097/TXD.0000000000001398
Journal volume & issue: Vol. 9, no. 1
p. e1398

Abstract

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Background. Cardiovascular disease is a major cause of morbidity and mortality in kidney transplant recipients. Trial evidence to improve cardiovascular outcomes is limited by inconsistent reporting of outcomes, which may also lack patient-relevance. This study aimed to assess the range and consistency of cardiovascular outcomes reported by contemporary trials in kidney transplant recipients. Methods. A systematic review of all randomized controlled trials involving adult kidney transplant recipients that reported at least 1 cardiovascular outcome from January 2012 to December 2019 was performed, including Embase, MEDLINE, Cochrane, and ClinicalTrials.gov electronic databases. Trial characteristics were extracted and all levels of specification of the cardiovascular outcome measures reported were analyzed (the measure definition, metric‚ and method of aggregation). Measures assessing a similar aspect of cardiovascular disease were categorized into outcomes. Results. From 93 eligible trials involving 27 609 participants, 490 outcome measures were identified. The outcome measures were grouped into 38 outcomes. A cardiovascular composite was the most common outcome reported (40 trials, 43%) followed by cardiovascular mortality (42%) and acute coronary syndrome (31%). Cardiovascular composite was also the most heterogeneous outcome with 77 measures reported followed by cardiovascular mortality (n = 58) and inflammatory biomarkers (n = 51). The most common cardiovascular composite outcome components reported were major cardiovascular events (18 trials), stroke unspecified (11 trials), and myocardial infarction unspecified (10 trials). Conclusions. There is substantial heterogeneity in cardiovascular outcome reporting in kidney transplant trials.

Published in Transplantation Direct

ISSN: 2373-8731 (Online)
Publisher: Wolters Kluwer
Country of publisher: United States
LCC subjects: Medicine: Surgery
Website: http://journals.lww.com/transplantationdirect/Pages/default.aspx

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