Table 3.
Sirolimus vs. CNI within three study arms
| Early | Intermediate | Late | ||||
|---|---|---|---|---|---|---|
| Sirolimus (N=16) | CNI (N=36) | Sirolimus (N=24) | CNI (N=20) | Sirolimus (N=21) | CNI (N=29) | |
| Recipient age, yrs | 54±9 | 54±11 | 56±11 | 50±17 | 56±13 | 53±16 |
| Male sex, n (%) | 9 (56) | 28 (78) | 17 (71) | 13 (65) | 17 (81) | 24 (83) |
| Time since heart transplant, yrs | 1.1 (1.0, 1.1)† | 0.2 (0.2, 1.0) | 2.2 (2.0, 3.0)† | 3.1 (2.3, 5.0) | 9.2 (6.5, 11.7) | 10.9 (8.1, 16.6) |
| Donor age, yrs | 27±12 | 33±13 | 33±14 | 29±13 | 26±11 | 26±12 |
| Previous CMV infection, n (%) | 8 (50) | 13 (36) | 7 (29) | 2 (10) | 2 (10) | 7 (24) |
| Treatment episodes of rejection, n (%) | 2 (13) | 6 (17) | 4 (17) | 1 (5) | 4 (19) | 6 (21) |
| Reason for conversion to sirolimus | ||||||
| CNI-induced nephropathy | 4 (25) | - | 16 (67) | - | 15 (71) | - |
| CAV | 1 (6) | - | 1 (5) | - | 3 (14) | - |
| CNI-related side effects | 0 (0) | - | 2 (9) | - | 1 (5) | - |
| Routine conversion protocol | 11 (69) | - | 5 (23) | - | 2 (10) | - |
| Comorbidities | ||||||
| Body mass index, kg/m2 | 27.2±5.9 | 25.8±4.4 | 27±5 | 28±6 | 28±5 | 27±6 |
| Diabetes, n (%) | 3 (19) | 11 (31) | 8 (33) | 3 (15) | 3 (14) | 5 (17) |
| Hypertension, n (%) | 12 (75) | 24 (67) | 19 (79) | 13 (65) | 17 (81) | 21 (72) |
| Total cholesterol, mg/dl | 228±48 | 199±48 | 195±46 | 188±40 | 179±31 | 163±43 |
| Triglyceride, mg/dl | 142 (116, 250) | 169 (107, 210) | 148 (107, 233) | 115 (81, 169) | 147 (122, 194) | 125 (78, 176) |
| HDL cholesterol. mg/dl | 54±13 | 57±22 | 60±18 | 53±14 | 51±18 | 50±13 |
| LDL cholesterol, mg/dl | 138±34† | 106±34 | 101±32 | 108±33 | 95±22 | 86±34 |
| Serum creatinine, mg/dl | 1.1±0.3* | 1.4±0.3 | 1.5±0.8 | 1.4±0.3 | 1.4±0.3 | 1.3±0.3 |
Data are expressed as mean±SD, median (interquartile range) or n (%).
*
P<0.05
†
P<0.01 vs. CNI.
CAV indicates cardiac allograft vasculopathy; CMV, cytomegalovirus; CNI, calcineurin inhibitors; HDL, high-density lipoprotein; and LDL, low-density lipoprotein.