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

Authors

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

Publication Date

1-1-2023

Journal

Transplantation Direct

DOI

10.1097/TXD.0000000000001398

PMID

36518792

PMCID

PMC9742089

PubMedCentral® Posted Date

12-7-2022

PubMedCentral® Full Text Version

Post-print

Published Open-Access

yes

Abstract

BACKGROIUND: 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.

Comments

Supplementary Material