Preliminary Results of a Prospective Randomized Study of Cyclosporine Versus Tacrolimus in the Development of Cardiac Allograft Vasculopathy at 1 Year After Heart Transplantation

Abstract Introduction and aims Cardiac allograft vasculopathy (CAV) is the leading cause of death after the first year post–heart transplantation (HT). Numerous factors have been implicated in the development of CAV. The aim of this prospective randomized study was to assess the impact of cyclosporine (CsA) and tacrolimus (Tac) on the development of CAV. Materials and methods From November 2006 to October 2008, 49 HT patients in our center were randomized to receive CsA or Tac. The additional treatment for all patients consisted of daclizumab induction and maintenance treatment with mycophenolate mofetil (1 g/12 hours) and steroids (withdrawal was not attempted). Thirteen patients died before coronary arteriography plus intravascular ultrasound of the left anterior descending artery was performed at 1 year after HT. Hence, the final number of patients included was 36 (18 per group). We considered significant CAV to be the presence of intimal proliferation >1 mm and/or >0.5 mm in 180°. The statistical methods were Student t and chi-square tests. Results There were no differences in baseline characteristics between the two groups. Nor were there significant differences in maximum intimal proliferation between the groups (CsA 0.65 ± 0.29 vs Tac 0.82 ± 0.51 mm; P = .292) or in the development of significant CAV when both criteria were combined (CsA 31.6% vs Tac 38.9%; P = .642). Conclusions One year after HT, no differences were detected in the development of significant CAV according to the type of calcineurin inhibitor used when combined with daclizumab induction and maintenance treatment with mycophenolate mofetil and steroids.