Ten-year results of a randomized trial comparing tacrolimus versus cyclosporine A in combination with mycophenolate mofetil after heart transplantation.
Guethoff S, Meiser BM, et al.Transplantation 2013; 95(4): 629-634.
Aims
To investigate the long term results of immunosuppressive regimes by comparing either tacrolimus (TAC) or cyclosporine A (CSA) with mycophenolate mofetil (MMF) and steroids after heart transplantation.
Interventions
Patients received TAC or CSA with MMF and steroids, following heart transplantation. Calcineurin inhibitors and MMF were adjusted to target levels (TAC: month 0-6=13-15mg/mL, month 7-12=10-12mg/mL, second year=8-10 mg/mL, third to fourth year=6-8mg/mL, fifth to tenth year=4-7mg/mL. CSA: month 0-6=200-300mg/mL, month 7-24=150-200mg/mL, third to tenth year=100-150mg/mL. Mycophenolic acid: month 0-6=2.5-4.0µg/mL, month 7 to tenth year:1.5-2.5µg/mL).
Participants
60 adult orthotopic heart transplant recipients.
Outcomes
The outcomes for this study included patient survival, acute rejection and cardiac allograft vasculopathy based on coronary angiography.
Follow-up
10 years.
CET Conclusions
This paper reports the ten-year follow up of a trial comparing tacrolimus with cyclosporine in heart transplantation. There was no difference in overall survival, although the study was probably too small to demonstrate anything but the largest of differences in this outcome. Tacrolimus was associated with significantly less acute rejection, less treatment failure and less cardiac allograft vasculopathy. There was no difference in CMV titres, malignancy or incidence of diabetes. Cyclosporine was associated with higher serum creatinine at five-year follow up but this was not bourne out at ten years.
Data analysis
Per protocol analysis
Quality notes
Previously assessed Meiser BM, Groetzner J et al. Tacrolimus or cyclosporine: which is the better partner for mycophenolate mofetil in heart transplant recipients? Transplantation 2004; 78:591.
Trial registration
Not reported.