Photopheresis for the prevention of rejection in cardiac transplantation

Background Photopheresis is an immunoregulatory technique in which lymphocy tes are reinfused after exposure to a photoactive compound (methox-salen) a nd ultraviolet A light. We performed a preliminary study to assess the safe ty and efficacy of photopheresis in the prevention of acute rejection of ca rdiac allografts. Methods A total of 60 consecutive eligible recipients of primary cardiac tr ansplants were randomly assigned to standard triple-drug immunosuppressive therapy (cyclosporine, azathioprine, and prednisone) alone or in conjunctio n with photopheresis. The photopheresis group received a total of 24 photop heresis treatments, each pair of treatments given on two consecutive days, during the first six months after transplantation. The regimen for maintena nce immunosuppression, the definition and treatment of rejection episodes, the use of prophylactic antibiotics, and the schedule for cardiac biopsies were standardized among all 12 study centers. All the cardiac-biopsy sample s were graded in a blinded manner at a central pathology laboratory. Plasma from the subgroup of 34 patients (57 percent) who were enrolled at the nin e U.S. centers was analyzed by polymerase-chain-reaction amplification for cytomegalovirus DNA. Results After six months of follow-up, the mean (+/-SD) number of episodes of acute rejection per patient was 1.44+/-1.0 in the standard-therapy group , as compared with 0.91+/-1.0 in the photopheresis group (P=0.04). Signific antly more patients in the photopheresis group had one rejection episode or none (27 of 33) than in the standard-therapy group (14 of 27), and signifi cantly fewer patients in the photopheresis group had two or more rejection episodes (6 of 33) than in the standard-therapy group (13 of 27, P=0.02). T here was no significant difference in the time to a first episode of reject ion, the incidence of rejection associated with hemodynamic compromise, or survival at 6 and 12 months. Although there were no significant differences in the rates or types of infection, cytomegalovirus DNA was detected signi ficantly less frequently in the photopheresis group than in the standard-th erapy group (P=0.04). Conclusions In this pilot study, the addition of photopheresis to triple-dr ug immunosuppressive therapy significantly decreased the risk of cardiac re jection without increasing the incidence of infection. (N Engl J Med 1998;3 39:1744-51.) (C) 1998, Massachusetts Medical Society.