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Published on: April 12, 2021
Range and Consistency of Cardiovascular Outcomes Reported by Clinical Trials in Kidney Transplant Recipients: A
Gregory J Wilson1,2,3, Kim Van4, Emma O'Lone4
1Faculty of Medicine, University of Queensland, Brisbane, QLD, Australia.
Insights
Cardiovascular outcomes in kidney transplant trials lack consistent reporting. This heterogeneity may impact patient-relevant evidence and requires standardization for better clinical trial interpretation.
Area of Science:
- Nephrology
- Cardiology
- Clinical Trials
Background:
- Cardiovascular disease (CVD) significantly impacts kidney transplant recipients' morbidity and mortality.
- Limited and inconsistently reported trial evidence hinders effective CVD outcome improvement strategies.
Purpose of the Study:
- To evaluate the diversity and consistency of cardiovascular outcome reporting in recent kidney transplant clinical trials.
- To identify common outcome measures and their heterogeneity within these trials.
Main Methods:
- Systematic review of randomized controlled trials (RCTs) in adult kidney transplant recipients (2012-2019).
- Searched Embase, MEDLINE, Cochrane, and ClinicalTrials.gov for trials reporting cardiovascular outcomes.
- Analyzed trial characteristics and categorized reported outcome measures by definition, metric, and aggregation.
Main Results:
- 93 eligible trials with 27,609 participants yielded 490 outcome measures, grouped into 38 distinct outcomes.
- Cardiovascular composite outcomes were most common (43%), followed by cardiovascular mortality (42%) and acute coronary syndrome (31%).
- High heterogeneity observed, particularly in cardiovascular composite outcomes (77 measures) and cardiovascular mortality (58 measures).
Conclusions:
- Contemporary kidney transplant trials exhibit substantial heterogeneity in reporting cardiovascular outcomes.
- This inconsistency poses challenges for evidence synthesis and patient-centered care.
- Standardization of outcome reporting is crucial for advancing CVD research in this population.
Abstract:
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.
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01:26Kidney Transplant II: Surgical Procedure
01:16Kidney Transplant III: Nursing Management
01:30Acute Kidney Injury IV: Diagnostic Studies and Prevention
01:24Chronic Kidney Disease II: Clinical Manifestations
01:29Acute Kidney Injury III: Clinical Manifestations