Objective: The purpose of this retrospective study is to review our experie
nce with tacrolimus as a rescue immunosuppressant for heart transplant reci
pients with refractory rejection or cyclosporine intolerance. Methods: From
June 1995 to November 1998, 15 cardiac transplant recipients were converte
d from our standard cyclosporine-based immunosuppressive regimen to a tacro
limus-based treatment. Each patient had been treated with cyclosporine, aza
thioprine and steroids. Six were switched to tacrolimus for persistent reje
ction, four for recurrent acute rejection and five for severe debilitating
side-effects attributed to cyclosporine. All ten patients converted to tacr
olimus because of rejection had been treated with high-dose methylprednisol
one 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 ra
nged from 44 to 1866 (median, 380) days. The range of follow-up after conve
rsion was 84-1379 (median, 806) days. Eleven patients are alive with a foll
ow-up period of 764 +/- 435 (median, 820) days. Four patients died between
90 and 930 (median, 464) days after conversion. The average number of episo
des of acute rejection/recipient decreased from 2.1 +/- 1.6 on the cyclospo
rine 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 patient-days), the results were 1.1 +/- 1.4 and 0.07 +/- 0.2, respectiv
ely (P < 0.01). The persistent/recurrent rejection resolved in all ten pati
ents who were converted to tacrolimus. None of the five cyclosporine intole
rant patients converted to tacrolimus experienced rejection after the chang
eover. Conclusions: In our experience, conversion from a cyclosporine-based
to a tacrolimus-based maintenance immunosuppression has been shown to be a
n effective and safe approach to the management of patients with persistent
or recurrent cardiac allograft rejection or those with cyclosporine intole
rance. (C) 2001 Elsevier Science B.V. All rights reserved.