The CECARI Study: Everolimus (Certican®) Initiation and Calcineurin Inhibitor Withdrawal in Maintenance Heart Transplant Recipients with Renal Insufficiency: A Multicenter, Randomized Trial.
In this 3-year, open-label, multicenter study, 57 maintenance heart transplant recipients (>1 year after transplant) with renal insufficiency (eGFR 30-60 mL/min/1.73 m2) were randomized to start everolimus with CNI withdrawal (N= 29) or continue their current CNI-based immunosuppression (N= 28). The primary endpoint, change in measured glomerular filtration rate (mGFR) from baseline to year 3, did not differ significantly between both groups (+7.0 mL/min in the everolimus group versus +1.9 mL/min in the CNI group,p= 0.18). In the on-treatment analysis, the difference did reach statistical significance (+9.4 mL/min in the everolimus group versus +1.9 mL/min in the CNI group,p= 0.047). The composite safety endpoint of all-cause mortality, major adverse cardiovascular events, or treated acute rejection was not different between groups. Nonfatal adverse events occurred in 96.6% of patients in the everolimus group and 57.1% in the CNI group (p< 0.001). Ten patients (34.5%) in the everolimus group discontinued the study drug during follow-up due to adverse events. The poor adherence to the everolimus therapy might have masked a potential benefit of CNI withdrawal on renal function.
Department of Cardiology, University Hospitals Leuven, 3000 Leuven, Belgium.
Jan
0000-0003-4490-5170
J
Van Keer
Department of Cardiology, University Hospitals Leuven, 3000 Leuven, Belgium.
David
D
Derthoo
Department of Cardiology, Cliniques Universitaires Saint-Luc, 1200 Bruxelles, Belgium.
Olivier
O
Van Caenegem
Department of Cardiology, University Hospitals Ghent, 9000 Ghent, Belgium.
Michel
M
De Pauw
Department of Cardiology, Centre Hospitalier Universitaire de Liège-Sart Tilman, 4000 Liège, Belgium.
Eric
E
Nellessen
Department of Cardiology, University Hospitals Leuven, 3000 Leuven, Belgium.
Nathalie
N
Duerinckx
Department of Cardiology, University Hospitals Leuven, 3000 Leuven, Belgium.
Walter
W
Droogne
Department of Cardiology, University Hospitals Leuven, 3000 Leuven, Belgium.
Gábor
G
Vörös
Department of Cardiac Surgery, University Hospitals Leuven, 3000 Leuven, Belgium.
Bart
B
Meyns
Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Hasselt University & Catholic University of Leuven, 3000 Leuven, Belgium.
Ann
A
Belmans
Department of Cardiology, University Hospitals Leuven, 3000 Leuven, Belgium.
Stefan
S
Janssens
Department of Cardiology, University Hospitals Leuven, 3000 Leuven, Belgium.
Johan
0000-0001-9246-6382
J
Van Cleemput
Department of Cardiology, University Hospitals Leuven, 3000 Leuven, Belgium.
Johan
J
Vanhaecke