Table 3.
Results of intravascular ultrasound (IVUS) substudies in randomized trials of everolimus with reduced-exposure cyclosporine versus MMF with standard-exposure cyclosporine.
| Parameter | A2310 [9] | B253 [2, 20] | ||||
|---|---|---|---|---|---|---|
| MMF | Everolimus 1.5 mg | P value | Azathioprine | Everolimus 1.5 mg/3.0 mg | P value | |
| Number of patients | ||||||
| 12 months | 101 | 88 | 72 | 70/69 | ||
| 24 months | — | — | 60 | 45/44 | ||
| Mean change in MIT from baseline, mm | ||||||
| 12 months | 0.07 ± 0.11 | 0.03 ± 0.05 | <0.00 | 0.10 | 0.04/0.03 | 0.01/0.003 |
| 24 months | — | — | 1 | 0.15 | 0.07/0.06 | 0.014/0.004 |
| Patients with CAV, % | ||||||
| 12 months | 26.7 | 12.5 | 0.018 | 52.8 | 35.7/30.4 | 0.045/0.01 |
| 24 months | — | — | 58.3 | 33.3/45.5 | 0.017/n.s. | |
CAV: cardiac allograft vasculopathy, defined as a change in MIT ≥ 0.5 mm as assessed by intravascular ultrasound (IVUS); MIT: maximal intimal thickness; MMF: mycophenolate mofetil.