Abstract
According to the FDA black box warning, everolimus should not be given in combination with anti-thymocyte globulin (ATG) induction therapy (which is given immediately after transplant). The large randomized trials with everolimus and cyclosporine (CsA) showed an increased incidence of infection and infectious mortality when ATG induction was also given. It is believed that the combination of proliferation signal inhibitor (PSI: everolimus or sirolimus) and induction therapy along with calcineurin inhibitor (CNI: CsA or tacrolimus) therapy creates an over immunosuppressed state and a risk for infectious complication. It is not known if PSI started later, between 2-12 months after heart transplant (HTx), with ATG induction therapy is safe. Therefore, we sought to evaluate our patients started on PSI between 2-12 months in the first year to assess for safety.
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