The CECARI Study: Everolimus (Certican®) Initiation and Calcineurin Inhibitor Withdrawal in Maintenance Heart Transplant Recipients with Renal Insufficiency: A Multicenter, Randomized Trial

Table 4

Comparison of randomized trials of everolimus in heart transplant recipients.

		FU	Timing	Intervention	Control	Renal function
						Baseline	Effect of intervention
(a) de novo
CNI-sparing
Eisen et al. [19]	634	1 y	at Tx	SE CsA + EVL	SE CsA + AZA	NA	EVL worse
Lehmkuhl et al. [24]	176	1 y	at Tx	re CsA + EVL	SE CsA + MMF	eGFR 74.7	No significant difference
Eisen et al. [20]	721	1 y	at Tx	re CsA + EVL	SE CsA + MMF	eGFR 66.8	EVL worse
Zuckermann et al. [25]	199	6 m	at Tx	re CsA+ EVL	SE CsA + EVL	SCr 1.3	No significant difference
Wang et al. [26]	25	6 m	at Tx	re CsA + EVL	SE CSA + EVL	SCr 1.1	No significant difference
CNI-free
SCHEDULE [21, 27]	115	3 y	+7 w	EVL + MMF	SE CsA + MMF	SCr 1.2	EVL better
MANDELA [28]	200	1 y	+6 m	EVL + MMF	re CNI + EVL	NA	Currently ongoing
(b) Maintenance
CNI-sparing
NOCTET [29, 30]	190	5 y	+6.3 y	re CNI + EVL + MMF/AZA	SE CNI + MMF/AZA	mGFR 47.6	EVL better
SHIRAKISS [31]	34	3 y	+2.6 y	re CsA + EVL	re CsA + MMF	CrCl 43.9	No significant difference
Bara et al. [32]	70	1 y	+4.8 y	re CxA + EVL	re CsA + MMF	SCr 2.1	No significant difference
CNI-free
CECARI (present study)	57	3 y	+7.0 y	EVL + MMF	re CNI + MMF	mGFR 38.9	No significant difference

AZA, azathioprine; CNI, calcineurin inhibitor (cyclosporine or tacrolimus); CsA, cyclosporine A; EVL, everolimus; MMF, mycophenolate mofetil; re, reduced exposure; SE, standard exposure; Tx, transplantation.
CrCl, creatinine clearance (mL/min); eGFR, estimated GFR (mL/min/1.73 m²); mGFR, measured GFR (mL/min); NA, not available; SCr, serum creatinine (mg/dL).
Timing of intervention relative to transplantation; FU, longest available follow-up; w, week; m, month; y, year.
In NOCTET, a total of 282 patients were included: 190 heart transplant + 92 lung transplant recipients.