TY - JOUR
T1 - Range and Consistency of Cardiovascular Outcomes Reported by Clinical Trials in Kidney Transplant Recipients
T2 - A Systematic Review
AU - Wilson, Gregory J.
AU - Van, Kim
AU - O'Lone, Emma
AU - Tong, Allison
AU - Craig, Jonathan C.
AU - Sautenet, Benedicte
AU - Budde, Klemens
AU - Forfang, Derek
AU - Gill, John
AU - Herrington, William G.
AU - Jafar, Tazeen H.
AU - Johnson, David W.
AU - Krane, Vera
AU - Levin, Adeera
AU - Malyszko, Jolanta
AU - Rossignol, Patrick
AU - Sawinski, Deirdre
AU - Scholes-Robertons, Nicole
AU - Strippoli, Giovanni
AU - Wang, Angela
AU - Winkelmayer, Wolfgang C.
AU - Hawley, Carmel M.
AU - Viecelli, Andrea K.
PY - 2023/1
Y1 - 2023/1
N2 - 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.
AB - 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.
KW - Cardiovascular disease
KW - Kidney transplant recipient
KW - Patient outcomes
UR - http://www.scopus.com/inward/record.url?scp=85143675115&partnerID=8YFLogxK
UR - http://purl.org/au-research/grants/NHMRC/1092597
UR - http://purl.org/au-research/grants/NHMRC/1128564
U2 - 10.1097/TXD.0000000000001398
DO - 10.1097/TXD.0000000000001398
M3 - Article
AN - SCOPUS:85143675115
SN - 2373-8731
VL - 9
JO - Transplantation Direct
JF - Transplantation Direct
IS - 1
M1 - E1398
ER -
