De novo calcineurin inhibitor free immunosuppression after cardiac transplantation is possible!

Objectives: The aim of this prospective pilot study was to investigate, for the first time since the introduction of cyclosporine, whether de novo calcineurin inhibitor free immunosuppression after HTx is efficacious and can prevent calcineurin inhibitor specific adverse effects. Material and Methods: Eight patients undergoing HTx were included. Immunosuppression consisted of trough level adjusted Sirolimus and Mycophenolate Mofetil. In addition, a 4-day-course of antithmocyte globuline was applied and corticosteroids were given for the first 6 postoperative months only. Target blood trough levels of Sirolimus and mycophenolic acid were in the range of 10–15 ng/mL and 2.5–4.0µg/ml, respectively. Survival data, acute rejection episodes and adverse events with a special emphasis on renal impairment, myelosuppression, hypercholesterolemia, hypertriglyceridemia and infections, were recorded. Results: With a mean follow-up of 8 months, patient survival rate was 100%. Freedom from acute rejection was 75%, the rejection incidence per patient was 0.25. Mean creatinine levels decreased within the first couple of weeks after transplantation and remained stable thereafter (1.1mg/dL). A moderate myelosuppressive effect did not necessitate dose reduction of immunosupressants, intermittently elevated cholesterol- and triglyeride levels decreased over time. Most frequent adverse events were pericardial effusions and peripheral edema. Conclusions: Complete abandonment of calcineurin inhibitor therapy by de novo use of the combination Sirolimus/Mycophenolate Mofetil after cardiac transplantation is safe and effective: Rejection can be completely avoided in the majority of patients and calcineurin inhibitor associated renal impairment does not occur. This regimen should, however, not be used without further evaluation in a lager setting.