Everolimus in Heart Transplantation: An Update

Table 2

Efficacy endpoints in randomized trials of everolimus with reduced-exposure cyclosporine versus MMF with standard-exposure cyclosporine.

Parameter	A2310 [9]				A2411 [5]
	12 months		24 months		12 months
	MMF	Everolimus 1.5 mg	MMF	Everolimus 1.5 mg	MMF	Everolimus 1.5 mg
Number of patients	271	282	271	282	84	92
Composite efficacy failure^a, %	33.6	35.1^b	41.3	39.4^c	41.7	32.6
AR associated with HDC, %	2.6	3.9	5.2	4.3	1.2	2.2
BPAR, ISHLT grade ≥ 3A, %	24.7	22.3	27.3	24.1	29.8	22.8^d
BPAR treated with antibody, %	No data	No data	No data	No data	2.4	5.4
Graft loss/re-transplant, %	1.8	1.4	3.7	2.5	Composite: 11.9	Composite: 10.9
Death, %	4.8	7.8^e	9.2	10.6^e
Loss to followup, %	3.7	3.2	5.2	3.5	No data	No data

AR: acute rejection; BPAR: biopsy proven acute rejection; HDC: hemodynamic compromise; ISHLT: International Society of Heart and Lung Transplantation; MMF: mycophenolate mofetil.
^aDefined as BPAR grade ≥ 3A (or any BPAR in A2310), acute rejection associated with hemodynamic compromise, graft loss/retransplant, death, or loss to followup.
^b𝑃=0.002 for noninferiority (noninferiority margin 13%); 𝑃=0.705 for no-difference test.
^cNoninferior to the MMF group (noninferiority margin 13%).
^d𝑃=0.005 for noninferiority.
^eIncluding one death in a patient who never received everolimus.