Transplant Trial Watch

Everolimus Initiation With Early Calcineurin Inhibitor Withdrawal in De Novo Heart Transplant Recipients: Long-term Follow-up From the Randomized SCHEDULE Study.

Gustafsson, F. et al.

Transplantation [record in progress].


Aims
This study aimed to investigate the long-term outcomes of early everolimus initiation with discontinuation of calcineurin inhibitor (CNI) versus a standard CNI regimen on heart and renal function, and their effects on the incidence of common major clinical events.

Interventions
Patients were randomized to either the everolimus group or the calcineurin inhibitor group with a ratio of 1:1.

Participants
115 de novo heart transplant recipients with an age range of 18–70 years.

Outcomes
The primary outcome was measured glomerular filtration rate (mGFR). The secondary outcomes were the presence of coronary allograft vasculopathy (CAV)), echocardiographical assessment of myocardial structure and function, and the incidence of adverse events or serious adverse clinical events.

Follow-up
5-7 years

CET Conclusions
This manuscript reports long-term follow-up (5-7 years post-transplant) from the SCHEDULE study, which randomised cardiac transplant recipients to everolimus and early CNI withdrawal or standard care (CNI, MMF and steroids). In the intent-to-treat population, the investigators demonstrate clinically significant superior renal function with everolimus treatment along with a reduction in coronary allograft vasculopathy. The increased rate of BPAR in this group does not appear to result in excess graft loss or dysfunction over the time-period studied. Given the high rates of long-term renal dysfunction in this population, these results are clinically very important. The authors should be applauded for continuing to follow-up with such high rates of retention, as long-term outcomes are key in studies such as this.

Trial registration
ClinicalTrials.gov - NCT01266148

Funding source
Industry funded