Background
Methods
Ethics statement
Study design and patients
Definitions and grouping
Primary and secondary objectives
Statistical analysis
Results
Baseline characteristics of enrolled patients
MIA score 0 | MIA score 2–4 | MIA score 6 | MIA score 8–10 | Total | p-value | |
---|---|---|---|---|---|---|
(n = 731) | (n = 502) | (n = 67) | (n = 48) | (N = 1348) | ||
Age at the transplantationa | 41.1 ± 11.9 | 42.8 ± 12.0 | 52.5 ± 10.4 | 57.7 ± 8.0 | 43.0 ± 12.3 | <0.001‡ |
Recipient’s sex (male, %) | 54.7 | 57.4 | 67.2 | 79.2 | 57.2 | 0.003 |
Body weight (kg)a | 59.9 ± 10.7 | 61.4 ± 12.0 | 62.4 ± 11.0 | 64.8 ± 9.0 | 60.8 ± 11.2 | 0.003‡ |
Height (cm)a | 164.2 ± 8.6 | 164.4 ± 8.8 | 164.4 ± 7.8 | 166.4 ± 7.4 | 164.4 ± 8.6 | 0.374 |
BMI (kg/m2)a | 22.1 ± 2.9 | 22.6 ± 3.5 | 23.0 ± 3.3 | 23.3 ± 2.6 | 22.4 ± 3.2 | 0.001§ |
Current smoker (%) | 10.6 | 9.1 | 23.3 | 6.4 | 9.8 | <0.001 |
Past medical history | ||||||
Hypertension (%) | 88.5 | 87.3 | 100.0 | 95.8 | 88.9 | 0.007 |
DM (%) | 14.1 | 21.5 | 49.3 | 64.6 | 20.4 | <0.001 |
Vascular diseases (%)b | 0.0 | 0.0 | 100.0 | 100.0 | 8.5 | <0.001 |
Dyslipidemia (%) | 21.4 | 29.1 | 35.0 | 63.8 | 26.6 | <0.001 |
Renal disease causing ESRD | 0.033 | |||||
DM (%) | 17.4 | 19.4 | 14.3 | 12.2 | 17.8 | |
Hypertension (%) | 10.0 | 9.7 | 17.9 | 12.2 | 10.4 | |
Glomerulonephritis (%) | 30.5 | 28.4 | 21.4 | 22.0 | 29.0 | |
PKD (%) | 5.3 | 3.9 | 14.3 | 4.9 | 5.2 | |
Others (%) | 36.8 | 38.6 | 32.1 | 48.7 | 37.6 | |
Laboratory Findings | ||||||
Serum albumin (g/dl)a | 3.9 ± 0.4 | 3.4 ± 0.5 | 3.9 ± 0.3 | 3.3 ± 0.6 | 3.7 ± 0.5 | <0.001‡§ |
CRP (mg/dl)a | 0.11 ± 0.11 | 0.97 ± 1.62 | 0.15 ± 0.13 | 1.25 ± 2.46 | 0.48 ± 1.17 | <0.001‡§ |
Total cholesterol (mg/dl)a | 161.6 ± 37.5 | 155.7 ± 44.9 | 156.5 ± 38.4 | 151.6 ± 48.5 | 158.8 ± 40.9 | 0.044 |
Triglyceride (mg/dl)a | 120.8 ± 67.2 | 125.9 ± 99.2 | 135.6 ± 89.5 | 133.6 ± 72.9 | 123.9 ± 81.1 | 0.419 |
LDL cholesterol (mg/dl)a | 91.5 ± 32.1 | 91.3 ± 31.8 | 87.2 ± 31.6 | 93.6 ± 43.2 | 91.3 ± 32.4 | 0.772 |
Intact PTH (pg/ml)a | 262.2 ± 312.8 | 238.7 ± 242.7 | 181.8 ± 183.8 | 249.7 ± 273.3 | 249.6 ± 279.4 | 0.29 |
CMV IgG positive (%) | 93.1 | 96.0 | 92.9 | 96.3 | 94.8 | 0.475 |
Dialysis before TPL (%) | 82.2 | 85.7 | 88.1 | 85.4 | 83.9 | 0.491 |
Preemptive TPL (%) | 17.8 | 14.3 | 11.9 | 14.6 | 16.1 | 0.491 |
HD:PD:both or switch (%) | 60.7:18.4:3.1 | 57.8:24.0:3.9 | 63.3:18.3:6.5 | 68.8:14.6:2.0 | 60.0:20.4:3.5 | 0.308 |
Dialysis duration (months)a | 26.7 ± 38.8 | 27.7 ± 38.0 | 38.4 ± 50.8 | 21.2 ± 27.7 | 27.4 ± 38.8 | 0.098 |
Donor information | ||||||
Deceased donor (%) | 20.1 | 21.3 | 29.9 | 17.0 | 21.0 | 0.003 |
Donor’s age (year)a | 40.2 ± 11.9 | 40.0 ± 12.4 | 41.7 ± 13.3 | 43.0 ± 12.8 | 40.3 ± 12.2 | 0.303 |
Donor’s sex (male, %) | 52.5 | 57.7 | 50.0 | 62.5 | 54.6 | 0.178 |
CMV IgG positive (%) | 54.9 | 69.9 | 47.8 | 60.4 | 60.3 | <0.001§ |
TPL (KT only : SPK : Others, %) | 89.1:3.1:7.8 | 91.4:4.8:3.8 | 85.1:4.5:10.4 | 89.6:2.1:8.3 | 89.8:3.8:6.4 | 0.053 |
Immunosuppressive agents | ||||||
Steroid maintenance strategy (%) | 92.6 | 89.5 | 100 | 85.7 | 90.9 | 0.625 |
CNI (CsA : Tacrolimus, %) | 34.2:65.3 | 35.8:63.6 | 22.8:75.4 | 29.7:70.3 | 34.0:65.4 | 0.254 |
Antimetabolites (Aza : MMF, %) | 6.5:88.1 | 10.2:79.4 | 10.5:80.7 | 8.6:82.9 | 8.0:84.6 | 0.095 |
Pretransplant MIA factor profile
Univariate | Multivariatea | |||||
---|---|---|---|---|---|---|
HR | 95 % CI | p-value | HR | 95 % CI | p-value | |
Age | 1.08 | 1.03–1.12 | 0.001 | 1.05 | 1.01–1.10 | 0.008 |
Male | 3.54 | 1.45–8.60 | 0.005 | 2.26 | 0.89–5.71 | 0.085 |
Smoking | 1.92 | 0.77–4.78 | 0.162 | |||
BMI (continuous variable) | 1.11 | 1.00–1.23 | 0.049 | |||
Hypertension | 4.27 | 0.58–31.44 | 0.154 | - | - | - |
DM | 3.55 | 1.78–7.05 | <0.001 | 2.58 | 0.99–6.76 | 0.054 |
Dialysis before KT (vs. preemptive) | 1.58 | 0.46–5.38 | 0.469 | - | - | - |
Dialysis vintage (months) | 1.01 | 0.99–1.013 | 0.146 | |||
Cholesterol (<150 mg/dL) | 1.46 | 0.69–3.07 | 0.324 | |||
Intact PTH | 1.00 | 0.99–1.00 | 0.384 | |||
Recipient CMV IgG (+) | 0.01 | 0.01–20.16 | 0.998 | |||
Donor sex (male) | 0.64 | 0.31–1.29 | 0.208 | - | - | - |
Donor age | 1.03 | 0.99–1.06 | 0.094 | - | - | - |
Deceased donor (vs. living donor) | 2.72 | 1.12–6.61 | 0.027 | 2.17 | 0.80–5.91 | 0.128 |
Donor CMV IgG (+) | 0.891 | 0.44–1.79 | 0.745 | |||
CsA (vs. tacrolimus) | 1.9 | 0.91–3.95 | 0.085 | - | - | - |
NODAT | 2.80 | 1.24–6.32 | 0.013 | 2.88 | 1.03–8.10 | 0.045 |
CMV disease | 0.046 | 0.01–14.33 | 0.686 | 0.15 | 0.01–41.48 | 0.712 |
MIA factors | ||||||
Albumin (lowest quartile vs. others) | 2.04 | 0.98–4.24 | 0.056 | 2.33 | 1.11–4.88 | 0.026 |
CRP (highest quartile vs. others) | 1.89 | 0.94–3.82 | 0.075 | 1.55 | 0.75–3.20 | 0.237 |
Previous history of vascular diseasea | 6.41 | 3.09–13.33 | <0.001 | 2.61 | 1.08–6.27 | 0.033 |
MIA scorea | ||||||
0 | Reference | Reference | ||||
2 | 1.17 | 0.45–3.05 | 0.742 | 2.14 | 0.77–5.96 | 0.147 |
4 | 2.51 | 0.79–8.03 | 0.121 | 1.86 | 0.39–8.73 | 0.436 |
6 | 5.23 | 1.76–15.53 | 0.003 | 2.93 | 0.90–9.54 | 0.075 |
8 | 7.53 | 2.28–24.85 | 0.001 | 3.11 | 0.73–13.29 | 0.125 |
10 | 32.96 | 7.30–148.94 | <0.001 | 34.29 | 8.29–141.84 | <0.001 |
Group by MIA scorea | ||||||
0 | Reference | Reference | ||||
2–4 | 1.33 | 0.56–3.16 | 0.517 | 2.05 | 0.79–5.35 | 0.142 |
6 | 5.28 | 1.78–15.68 | 0.003 | 3.06 | 0.94–9.99 | 0.063 |
8–10 | 11.18 | 4.12–30.33 | <0.001 | 6.12 | 1.84–20.32 | 0.003 |
MIA score 0 | MIA score 2 | MIA score 4 | MIA score 6 | MIA score 8 | MIA score 10 | Total | |
---|---|---|---|---|---|---|---|
(n = 731) | (n = 398) | (n = 104) | (n = 67) | (n = 39) | (n = 9) | (N = 1348) | |
Albumin lower quartile (%)a | 0 | 191 (48.0) | 104 (100) | 0 | 24 (61.5) | 9 (100) | 335 (24.3) |
CRP upper quartile (%)a | 0 | 207 (52.0) | 104 (100) | 0 | 15 (38.5) | 9 (100) | 340 (24.9) |
Atherosclerosis (%)a | 0 | 0 | 0 | 67 (100) | 39 (100) | 9 (100) | 116 (8.5) |