Tacrolimus and Single Intraoperative High-dose of Anti-T-lymphocyte Globulins Versus Tacrolimus Monotherapy in Adult Liver Transplantation: One-year Results of an Investigator-driven Randomized Controlled Trial.Iesari S, Ackenine K, et al.
Annals of Surgery, 2018; 268(5): 776-783.
To evaluate whether intra-operative induction with anti-lymphocytic serum is superior to no induction in adult liver transplantation.
Participants were randomized to tacrolimus monotherapy (n=107) or to tacrolimus plus induction with a single, intraoperatively-administered, high dose of rabbit anti-T-lymphocyte globulins (n=105).
206 adult liver transplant recipients (aged >15 years).
The primary endpoint was the attainment of stable liver function with tacrolimus monotherapy, in absence of rejection. Secondary endpoints were incidence of biopsy-proven acute cellular rejection, clinical rejection (ie, requiring treatment), and patient and graft survival. Safety was also assessed.
This single-blind randomized controlled trial from Belgium investigated the use of high-dose ATG with tacrolimus monotherapy following liver transplantation. The investigators found that total immunosuppressive burden, including the proportion of steroid-free patients and the proportion of patients on tacrolimus monotherapy, was the same between arms. There was a trend towards worse graft survival in the ATG group, mainly due to haemodynamic instability and perioperative complications in these patients. These results suggest that the addition of ATG, at least at the high doses used here, does not improve outcomes following liver transplantation; indeed it may be detrimental. It should be noted that recruitment took place over an unusually long period (from 2007-2016), although consecutive patients were recruited.
EudraCT - 2006–004830–34