Transplant Trial Watch

Cardiac Response to Early Conversion from Calcineurin Inhibitor to Everolimus in Renal Transplant Recipients - A 3 year serial echocardiographic substudy of the randomized controlled CENTRAL trial.

Murbraech K, Massey R, et al.

Clinical Transplantation 2015: 29 (8): 678-84.


Aims
To examine the cardiac responses of everolimus versus calcineurin inhibitors (CNI) in renal transplant recipients over a three year period.

Interventions
This was a substudy of the three year CENTRAL study where patients were randomized at week 7 after transplantation to remain on cyclosporine A (CsA), or to convert to everolimus. All patients completed echocardiographic evaluations at baseline, 1 year and 3 years.

Participants
39 low- to medium-risk de novo kidney transplant recipients aged between 31-81 years

Outcomes
Outcomes were echocardiographic markers of left ventricular hypertrophy (LVH), left ventricular mass index (LVMi) and systolic and diastolic function.

Follow-up
3 years

CET Conclusions
This manuscript reports the three year results from a substudy of patients entered into the CENTRAL trial, concentrating on cardiac outcomes. In the original study, renal transplant recipients were randomised to cyclosporine A or early conversion to everolimus at 7 weeks post-transplant. In this small single centre subset of the original patient cohort, the authors conclude that no clinically relevant differences in echocardiographic parameters (morphology or function) are apparent. Whilst this is an interesting topic due to the potential benefits of early CNI withdrawal, the limitations of this small analysis mean that it doesn’t really categorically answer the question that it sets out to. The sample size is small (63 patients randomised) and hampered by incomplete follow-up (only 39 patients completed the study). It is also unclear how patients for the substudy were selected and therefore whether they are representative of the overall population. It does, however, suggest that any potential cardiac benefits from CNI avoidance potential benefit are likely to be small.

Jadad score
3

Data analysis
Modified intention-to-treat analysis

Allocation concealment
Yes

Quality notes
Score based on Murbraech K, Holdaas H et al. Cardiac response to early conversion from calcineurin inhibitor to everolimus in renal transplant recipients: an echocardiographic substudy of the randomized controlled CENTRAL trial. Transplantation 2014; 97: 184.

Trial registration
Clinicialtrials.gov - NCT00634920

Funding source
Not reported