Background: Given their adverse effects, there is growing interest in omitting corticosteroids from the initial maintenance immunosuppression (IS) regimen after heart transplant (HT). However, evidence for the efficacy of this strategy is limited.
Hypothesis: Steroid-free and steroid-containing maintenance regimens are associated with comparable outcomes following HT.
Methods: We included patients who received HT between July 2004 and April 2014 and were discharged on an initial maintenance regimen with both tacrolimus and mycophenolic acid, with or without corticosteroids, and with no other IS medications. Patients with rejection or graft failure (death or re-transplant) prior to discharge were excluded. Survival analyses compared outcomes between steroid-free and steroid-treated patients, including time from discharge to graft failure, hospitalization, and infection and rejection requiring hospitalization.
Results: Of 10,080 included patients, 15%, 22%, 11%, and 50% experienced graft failure, infection, rejection, and hospitalization, respectively during the follow-up period (2004 - 2014). Steroid-free regimens were used in 8.2%. Steroid-free patients had lower risks of hospitalization (HR = 0.78, p < 0.0001), infection (HR = 0.56, p < 0.0001), and rejection (HR = 0.66, p = 0.018). There was no significant difference in the risk of graft failure (p = 0.12).
Conclusions: Steroid-free and steroid-treated patients have comparable graft survival after HT and differ with respect to other selected outcomes. Further research will determine whether this stems from differences in efficacy or patient mix. A steroid-free strategy is likely optimal for selected patients.