Pii: S1010-7940(01)00672-8

Objective: The purpose of this retrospective study is to review our experience with tacrolimus as a rescue immunosuppressant for heart transplant recipients with refractory rejection or cyclosporine intolerance. Methods: From June 1995 to November 1998, 15 cardiac transplant recipients were converted from our standard cyclosporine-based immunosuppressive regimen to a tacrolimus-based treatment. Each patient had been treated with cyclosporine, azathioprine and steroids. Six were switched to tacrolimus for persistent rejection, four for recurrent acute rejection and ®ve for severe debilitating side-effects attributed to cyclosporine. All ten patients converted to tacrolimus because of rejection had been treated with high-dose methylprednisolone intravenously and four had also received anti-lymphocyte globulin (ALG; one patient) or anti-thymocyte globulin (ATG; three patients) preparations. Results: The time between transplantation and conversion to tacrolimus ranged from 44 to 1866 (median, 380) days. The range of follow-up after conversion was 84±1379 (median, 806) days. Eleven patients are alive with a follow-up period of 764 ^ 435 (median, 820) days. Four patients died between 90 and 930 (median, 464) days after conversion. The average number of episodes of acute rejection/recipient decreased from 2.1 ^ 1.6 on the cyclosporine regimen to 0.2 ^ 0.4 on the tacrolimus regimen (P , 0:001). When the incidence of acute rejection was normalized for follow-up times (episodes/100 patientdays), the results were 1.1 ^ 1.4 and 0.07 ^ 0.2, respectively (P , 0:01). The persistent/recurrent rejection resolved in all ten patients who were converted to tacrolimus. None of the ®ve cyclosporine intolerant patients converted to tacrolimus experienced rejection after the changeover. Conclusions: In our experience, conversion from a cyclosporine-based to a tacrolimus-based maintenance immunosuppression has been shown to be an effective and safe approach to the management of patients with persistent or recurrent cardiac allograft rejection or those with cyclosporine intolerance. q 2001 Elsevier Science B.V. All rights reserved.