Late Calcineurin Inhibitor Withdrawal Prevents Progressive Left Ventricular Diastolic Dysfunction in Renal Transplant Recipients.
Mourer JS, Ewe SH, et al.Transplantation 2012; 94(7): 721-728.
Aims
To evaluate the effects of late withdrawal of a calcineurin inhibitor (CNI) or mycophenolate mofetil (MMF) on echocardiographic parameters in renal transplant recipients.
Interventions
The report describes a sub-study of a randomised trial that evaluated the efficacy of CNI versus MMF withdrawal.
Participants
119 stable renal transplant patients on CNI-based maintenance immunosuppressive therapy with MMF and steroids at least 6 months after transplantation.
Outcomes
The outcome of the cardiovascular substudy was the change in echocardiographic parameters 2 years after randomisation. Echocardiographic parameters included LVED diameter, LVES diameter, LV septum thickness, LV posterior wall thickness, LVESV index, LV mass index, E-wave deceleration time, LVEDV index, myocardial performance index and LA volume index. The primary outcome of the main study was the change in Modification of Diet in Renal Disease clearance from baseline after randomisation to CNI or MMF withdrawal. The secondary outcomes included incidence of acute rejections, proteinuria, patie
Follow-up
2 years after randomisation
CET Conclusions
In this sub-study of a larger RCT evaluating the effect on renal function of concentration controlled withdrawal of CNI or MMF on renal function, 108 patients entered the sub-study of cardiac function at a medium time of two years after transplantation. Withdrawal of a CNI resulted in less progression of left ventricular diastolic dysfunction in contrast to the group in whom MMF was withdrawn where the left atrial volume index actually increased. Thus late CNI withdrawal prevented progressive deterioration of left ventricular diastolic function in addition to making blood pressure easier to control.
Data analysis
Modified intention-to-treat analysis
Quality notes
The quality assessment is based on a previous report of the same trial: “Mourer JS, Hartigh Jd, et al. Randomized trial comparing late concentration-controlled calcineurin inhibitor or mycophenolate mofetil withdrawal. Transplantation, 93(9): 887-94, 2012â€.
Trial registration
NCT00169910 (ClinicalTrials.gov)