High graft protection and low incidences of infections, malignancies and other adverse effects with intra-operative high dose ATG-induction: a single centre cohort study of 760 cases.

Background: In 1990 we introduced the intra-operative single high-dose induction (HDI) with ATG-Fresenius as a novel renal sparing concept. The aim of this analysis was to compare both the long-term patient and graft survival and the incidences of adverse effects in recipients treated with standard triple-drug therapy (TDT) alone or with an additional HDI with ATG-F.

Material And Methods: A total of 760 renal transplant recipients receiving either TDT, consisting of steroids, azathioprine and cyclosporine (n=238) or TDT + 9mg/kg ATG-F intra-operatively (n=522) were included in this retrospective analysis.

Results: Compared to the TDT cohort the graft and patient survival over the entire ten year period was significantly prolonged in the TDT+HDI cohort. In contrast, main adverse effects (TDT+HDI vs. TDT) such as malignancies (4.4 vs. 2.1%), PTLD (0.4 vs. 0.4%), CMV diseases (18.6 vs. 15.5%), Herpes zoster infections (2.9 vs. 1.3%), bacterial pneumonias (3.1 vs. 1.3%) and post-operative thrombocytopenia <50×10³/µl (0.5 vs. 1.3%) did not significantly differ between the two immunosuppressive regimens. Only CMV-IgM seroconversions occurred significantly more in the HDI cohort (39.3 vs. 23.5%). The absolute numbers of CD3, CD4 and CD8 cell counts were significantly reduced in TDT+ATG-F HDI cohort only over a time period of about five days.

Conclusions: This world-wide largest single-centre cohort analysis clearly shows the superiority of the HDI with ATG-F compared to TDT alone in improving long-term graft survival without increasing the risk for infections, malignancies or other adverse effects.