Failed Prednisone Taper off after Heart Transplant: Is There a Price To Be Paid?

Abstract

Purpose A prednisone taper off protocol (PTOP) is is often initiated in heart transplant recipients 6 months post transplant to avoid the long-term adverse effects of steroid therapy. There have been no large randomized trials of steroid weaning as the benefits of steroid free immunosuppression have been assumed. The purpose of this study was to compared the long-term outcomes of patients who underwent PTOP with the outcomes of patients who did not tolerate PTOP or those who were not candidates. Methods and Materials We evaluated 577 patients transplanted between 1994 and 2010 who underwent PTOP at 6 months post-transplant. Patients who successfully completed PTOP (n=530), initiated but did not complete PTOP (n=47) and a control group (heart transplant patients who did not qualify for PTOP, n=326) were assessed for subsequent 5-year survival, freedom from cardiac allograft vasculopathy (CAV) and non-fatal major adverse cardiac events (NF-MACE; myocardial infarction, heart failure, percutaneous coronary intervention, stroke). Results Prednisone withdrawal beginning at 6 months after transplant was successful in 530/577 (92%) patients. PTOP failed (n=47) due to rejection or significant steroid withdrawal side effects. Successful PTOP patients had significantly higher 5-year survival compared with failed PTOP patients and control patients, and significantly higher freedom from NF-MACE than control patients. ( Table ) Conclusions PTOP at 6-months after heart transplant is successful in the majority of patients and confers good prognosis. Patients who fail PTOP have worse survival, and it is not clear if PTOP failure is a marker or cause of poor outcomes. A randomized trial of PTOP is warranted. Patients with 1-Year conditional survival transplanted between 1994 and 2010 Outcomes Prednisone Wean Success (n=530) Prednisone Wean Fail (n=47) No Prednisone Wean (n=326) 5-Year Actuarial Survival 94% 81%* 83%* 5-Year Freedom from CAV 75% 64% 73% 5-Year Freedom from NF-MACE 89% 81% 81% * * p