Table 2.
Effect of allocation to sirolimus‐based maintenance therapy on graft rejection, graft survival, and safety outcomes
| Sirolimus (n = 197) | Tacrolimus (n = 197) | Rate ratio (95% CI) | P value | |
|---|---|---|---|---|
| Graft rejection | ||||
| Cellular | ||||
| Banff 1 | 23 (11.7%) | 5 (2.5%) | ||
| Banff 2 | 1 (0.5%) | 0 (0.0%) | ||
| Banff 3 | 1 (0.5%) | 0 (0.0%) | ||
| Unknown | 0 (0.0%) | 0 (0.0%) | ||
| Any | 25 (12.7%) | 5 (2.5%) | ||
| Humoral | ||||
| Banff 1 | 1 (0.5%) | 0 (0.0%) | ||
| Banff 2 | 4 (2.0%) | 2 (1.0%) | ||
| Banff 3 | 0 (0.0%) | 0 (0.0%) | ||
| Unknown | 1 (0.5%) | 0 (0.0%) | ||
| Any | 6 (3.0%) | 2 (1.0%) | ||
| Unknown | 1 (0.5%) | 0 (0.0%) | ||
| All biopsy‐proven acute rejectiona | 29 (14.7%) | 6 (3.0%) | 5.15 (2.14‐12.41) | <.001 |
| Reasons for transplant failure | ||||
| Glomerular disease | 1 (0.5%) | 0 (0.0%) | ||
| Fibrosis/atrophy | 0 (0.0%) | 1 (0.5%) | ||
| Medical/surgical condition | 1 (0.5%) | 0 (0.0%) | ||
| Rejection | 2 (1.0%) | 0 (0.0%) | ||
| Unknown | 4 (2.0%) | 3 (1.5%) | ||
| Any graft failure | 8 (4.1%) | 4 (2.0%) | 1.99 (0.64‐6.18) | .23 |
| Serious infections | ||||
| Opportunistic infections | ||||
| Cytomegalovirus infection | 8 (4.1%) | 8 (4.1%) | 1.00 (0.38‐2.68) | .99 |
| BK virus infection | 1 (0.5%) | 3 (1.5%) | ||
| Fungal infection | ||||
| Noninvasive | 3 (1.5%) | 2 (1.0%) | ||
| Invasive | 0 (0.0%) | 1 (0.5%) | ||
| Any | 3 (1.5%) | 3 (1.5%) | 1.00 (0.20‐4.97) | 1.00 |
| Other opportunistic infection | ||||
| PCJ | 5 (2.5%) | 1 (0.5%) | ||
| Mycobaterial | 0 (0.0%) | 0 (0.0%) | ||
| Other | 8 (4.1%) | 7 (3.6%) | ||
| Any other opportunistic infection | 12 (6.1%) | 8 (4.1%) | ||
| Any opportunistic infection | 22 (11.2%) | 22 (11.2%) | 1.00 (0.56‐1.81) | .99 |
| Nonopportunistic infections | ||||
| Urinary tract | 30 (15.2%) | 29 (14.7%) | ||
| Respiratory tract | 32 (16.2%) | 19 (9.6%) | ||
| Gastrointestinal | 26 (13.2%) | 9 (4.6%) | ||
| Central nervous system | 1 (0.5%) | 1 (0.5%) | ||
| Other | 33 (16.8%) | 25 (12.7%) | ||
| Any nonopportunistic infection | 83 (42.1%) | 60 (30.5%) | 1.54 (1.11‐2.15) | .010 |
| Any serious infection | 95 (48.2%) | 70 (35.5%) | 1.51 (1.11‐2.06) | .008 |
| Cancer | ||||
| Hematologic cancer | ||||
| Posttransplantation lymphoproliferative disorder | 1 (0.5%) | 4 (2.0%) | ||
| Other hematologic cancer | 0 (0.0%) | 2 (1.0%) | ||
| Any hematologic cancer | 1 (0.5%) | 5 (2.5%) | 0.26 (0.05‐1.30) | .10 |
| Skin cancer | ||||
| Nonmelanoma skin cancer | 4 (2.0%) | 6 (3.0%) | 0.67 (0.19‐2.30) | .52 |
| Melanoma | 0 (0.0%) | 1 (0.5%) | ||
| Any skin cancer | 10 (5.1%) | 9 (4.6%) | 1.11 (0.45‐2.74) | .81 |
| Other cancerb | 7 (3.6%) | 6 (3.0%) | 1.16 (0.39‐3.45) | .78 |
| Any cancer | 17 (8.6%) | 17 (8.6%) | 1.00 (0.51‐1.97) | .99 |
| Mortality | ||||
| Cause of death | ||||
| Vascular | 7 (3.6%) | 2 (1.0%) | ||
| Infection | 1 (0.5%) | 1 (0.5%) | ||
| Cancer | 2 (1.0%) | 3 (1.5%) | ||
| Other | 1 (0.5%) | 3 (1.5%) | ||
| Any death | 11 (5.6%) | 9 (4.6%) | 1.23 (0.51‐2.95) | .64 |
Presumed rejection occurred in 5 vs 1 participants, making the total of any acute rejection (biopsy proven or presumed) 31 vs 7. PCJ, Pneumocystis jirovecii.
a
Rate ratio for any biopsy‐proven acute rejection was calculated using Cox proportional hazards model.
b
Other cancer consists of lung (1 vs 2), gastrointestinal (1 vs 0), hepatobiliary (1 vs 0), breast (1 vs 0), and other (3 vs 3).