Controlled randomized study comparing the cardiovascular profile of everolimus with tacrolimus in renal transplantation.
Cruzado JM, Pascual J, et al.Transplant International 2016 [record in progress].
Aims
To assess whether conversion to everolimus (EVR) is associated with reduction of left ventricular hypertrophy (LVH) at 24 months in renal allograft recipients receiving maintenance immunosuppression therapy with tacrolimus (TAC) and mycophenolate mofetil (MMF)/mycophenolic acid (MPA).
Interventions
Participants were randomized to either remain on a TAC regimen or to convert to EVR regimen, both in combination with MPA.
Participants
Recipients of a first or second single-kidney transplant within the last 3 years who were ≥ 6 months postttransplant, aged 18-70years and receiving TAC plus MPA prior to the study.
Outcomes
The primary outcome measured was LVH. Secondary outcomes include cardiovascular profile improvement, safety assessments and biopsy-proven acute rejection, graft loss and death.
Follow-up
24 months
CET Conclusions
This study of the effect of everolimus versus tacrolimus on left ventricular hypertrophy was well conducted and reported. The study was run over 4 years at 9 centres, this equates to roughly 2 patients per centre, per year. Initially it is hard to work out if the treatment improved LVH as all of the parameters of morphological and functional echocardiography are presented. It actually looks like patients continuing on tacrolimus saw a significant reduction in percentage with LVH at 24 months, whereas a similar proportion converted to everolimus still had LVH. Whilst both groups had reductions in concentric hypertrophy, the reduction in concentric remodelling seen with everolimus was offset by an increase in eccentric hypertrophy. Left ventricular mass index was reduced in both treatment arms after 24 months.
Data analysis
Modified intention-to-treat analysis
Trial registration
Clinicaltrials.gov - NCT01169701