Incidence and severity of acute cardiac allograft rejection with two different low-dose cyclosporine maintenance protocols.

Currently cyclosporine (CyA) represents the main immunosuppressive agent used after cardiac transplantation and usually is administered in combination with prednisone and/or azathioprine for prevention of graft rejection. From March, 1984, to August, 1987, 53 patients underwent orthotopic heart transplantation for terminal-stage heart disease at the Second Department of Surgery, University of Vienna. All patients received CyA in increasing dosage (3 mg/kg to 6-10 mg/kg) postoperatively according to renal function, obtaining a trough high-pressure liquid chromatographic whole-blood target level of 200 to 400 ng/ml at the end of the first week. CyA was subsequently tapered to 100 to 150 ng/ml after 6 months. From March, 1984, through April, 1986, maintenance immunosuppression was carried out with a double-drug regimen of CyA and azathioprine. Since May, 1986, a triple-drug schedule was applied with CyA, azathioprine, and prednisone. Under triple-drug therapy, the incidence of mild, moderate (p less than 0.0001), and severe (p = 0.05) allograft rejection proven by endomyocardial biopsy decreased significantly with a corresponding increase of absent (p less than 0.0001) rejection. Freedom from moderate, severe, and lethal graft rejection, number of rejection episodes per patient after 1 year (double drug, 1.0, versus triple drug, 2.5), and patient survival disclosed significant improvement for recipients of the triple-drug regimen. Both groups had the same incidence of infectious complications; freedom from death by infection after 1 year was 90% versus 91% (double versus triple drug, p = 0.20).(ABSTRACT TRUNCATED AT 250 WORDS)