Journal of Transplantation / 2013 / Article / Tab 2

Review Article

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.

ParameterA2310 [9]A2411 [5]
12 months24 months12 months
MMFEverolimus 1.5 mgMMFEverolimus 1.5 mgMMFEverolimus 1.5 mg

Number of patients2712822712828492
Composite efficacy failurea, %33.635.1b41.339.4c41.732.6
AR associated with HDC, %2.63.95.24.31.22.2
BPAR, ISHLT grade ≥ 3A, %24.722.327.324.129.822.8d
BPAR treated with antibody, %No dataNo dataNo dataNo data2.45.4
Graft loss/re-transplant, %1.81.43.72.5Composite: 11.9Composite: 10.9
Death, %4.87.8e9.210.6e
Loss to followup, %3.73.25.23.5No dataNo 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.
b for noninferiority (noninferiority margin 13%); for no-difference test.
cNoninferior to the MMF group (noninferiority margin 13%).
d for noninferiority.
eIncluding one death in a patient who never received everolimus.

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