Does short-course induction with OKT3 improve outcome after heart transplantation? A randomized trial.

OKT3 is often used routinely for induction immunotherapy or selectively to avoid acute cyclosporine nephrotoxicity in heart transplant recipients at high risk for immediate postoperative kidney failure. It has not been shown in a randomized trial to be useful in patients at low risk for early kidney failure. We randomized 30 patients with a serum creatinine level of less than 1.4 mg/dl before heart transplantation to be treated with triple-drug immunotherapy with cyclosporine, which was started before surgery, (group 1) or to be treated with OKT3 for 4 to 6 days after surgery with oral cyclosporine, which was started between days 2 and 4, after renal function had stabilized (group 2). Follow-up for 6 months revealed no significant differences in the total number of rejection episodes, total number of infections, or in the serum creatinine level. Four patients in group 1 and five patients in group 2 have had no rejection. OKT3 showed a trend to delay time to first rejection (p = 0.10), as has been reported for the 14-day induction course of OKT3. A short course of OKT3 induction in heart transplant recipients at low risk for immediate postoperative kidney failure prolongs the time to first rejection for most patients but does not appear to reduce the total incidence of rejection in the first 6 months after heart transplantation.

RCT Entities:   Population Interventions Outcomes