Thymoglobulin induction and steroid avoidance in cardiac transplantation: results of a prospective, randomized, controlled study

:  Background:  Chronic use of corticosteroids (CS) following transplantation is associated with significant long-term morbidities. Minimizing exposure to CS to improve long-term outcomes, without compromising allograft function, remains an important goal in transplantation. Objectives:  This single-center, prospective, randomized, open-label study was designed to evaluate the efficacy of Thymoglobulin® as part of a CS-sparing regimen in cardiac transplantation. Methods:  Thirty-two low-risk cardiac transplant patients were randomized in a 1:1 ratio to receive either a Thymoglobulin-based CS-avoidance regimen (CS-avoidance group; n = 16) or a long-term CS-based regimen with no antibody induction (control group; n = 16). Pulse CS therapy was used for the treatment of acute cellular rejection in both groups. Results:  Baseline characteristics were similar between groups. At one yr, there was no significant difference in the mean incidence of acute cellular rejection (≥3A) episodes between the CS-avoidance and control groups, 0.81 ± 1.05 and 1.07 ± 1.03, respectively. Importantly, the CS-avoidance patients had significant improvement in muscle strength and less bone loss compared with the control patients during the first six months post-transplant. Conclusions:  CS-avoidance regimen with Thymoglobulin induction appeared to be safe and effective in cardiac transplantation. Further studies are required to demonstrate the long-term safety and benefits of such a regimen.