Long-term results in heart transplant recipients receiving tacrolimus based immunosuppression

Introduction: The aim of this study was to analyse the impact of tacrolimus-based immunosuppression on outcome after heart transplantation with special regard towards long-term side effects, since our center has experience with tacrolimus after HTx since 1993. Methods: The records of 361 heart transplant recipients who were assigned to former clinical trials (1993–2006, mean age 48±16.9 years, mean follow-up 7.2±3.8 years) were analysed retrospectively. Group 1 (n=226) received tacrolimus/azathioprin or tacrolimus/mycophenolatemofetil, group 2 (n=135) cyclosporin/azathioprin or cyclosporin/mycophenolatemofetil for maintenance immunosuppression. Outcome parameters such as survival, transplant vasculopathy, rejection, renal function, diabetes and hyperlipidemia were documented up to 13 years after HTx. Kaplan Meier survival estimates, log-rank test, t-test and multivariate Cox-regression models were used for statistical data-analysis. Results: Survival after 1-, 5- and 10 years was 93.8%, 87.6% and 78.1% in group 1 vs. 93.3%, 83.5% and 67% in group 2 (p=0.06). Freedom from transplant vasculopathy at 5 and 10 years was 84.1% and 76.3% vs. 84.0% and 63.4% in group 2 (p=0.21). Freedom from rejection in tacrolimus patients was 68.8% at 1 year and 60.4% at 10 years vs. 44.9% and 36.1% in the cyclosporin group (p<0.001). Hypercholesterinaemia occurred significantly more often in cyclosporin treated patients while there was a trend towards more frequent manifestations of post-transplant diabetes mellitus in the tacrolimus group. Renal function revealed no significant differences even after 10 years. Conclusion: There was superior prevention from acute rejection and a trend towards a favorable survival using tacrolimus-based immunosuppression after HTx.