Between January 1987 and September 1991, 112 operative survivors of heart transplantation were initially immunosuppressed with cyclosporin A and azathioprine without prednisone. Eighty-eight patients (79%) remained on a regimen of double therapy for a mean follow-up of 25 ± 15 months (range, 1 to 54 months), whereas 24 patients (21%) had oral prednisone, 5 mg/day, added to maintenance therapy for persistent or repeated rejection. There were 5 early deaths (4%) because of acute rejection (4 patients) or infection (1 patient). Only 1 patient died late after heart transplantation of chronic rejection. Actuarial survival was 95% ± 2% and 94% ± 3% at 12 and 48 months, respectively. Mean rate of acute rejection was 1.7 ± 1.0 episodes per patient, with a 5% ± 2% freedom from rejection at 48 months. Ten patients (9%) required in-hospital treatment for infection; the actuarial freedom from infectious episodes was 85% ± 4% at 48 months. Actuarial freedom from hypertension was 43% ± 7% at 48 months. At annual catheterization, mean left ventricular ejection fraction was 0.64 ± 0.08 and 0.62 ± 0.05 at 1 year and 4 years, respectively, with evidence of coronary lesions in 8 patients (8%). In conclusion, steroid-free immunosuppression after heart transplantation is associated with a high incidence of acute rejection. However, the excellent medico-term survival and the low incidence of both infection and chronic rejection seem to justify a wider use of such treatment.
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