BACKGROUND: A prednisone taper off protocol 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 prednisone taper off protocol with the outcomes of patients who did not tolerate prednisone taper off protocol or those who were not candidates.
METHODS: We evaluated 577 patients transplanted between 1994 and 2010 who underwent prednisone taper off protocol at 6 months post-transplant. Patients who successfully completed prednisone taper off protocol (n=530), initiated but did not complete prednisone taper off protocol (n=47) and a control group (heart transplant patients who did not qualify for prednisone taper off protocol, 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. Prednisone taper off protocol failed (n=47) due to rejection or significant steroid withdrawal side effects. Successful prednisone taper off protocol patients had significantly higher 5-year survival compared with failed prednisone taper off protocol patients and control patients, and significantly higher freedom from NF-MACE than control patients.
|Outcomes in Patients with 1-Year Conditional Survival||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%*|
CONCLUSION: Prednisone taper off protocol at 6-months after heart transplant is successful in the majority of patients and confers good prognosis. Patients who fail prednisone taper off protocol have worse survival, and it is not clear if prednisone taper off protocol failure is a marker or cause of poor outcomes. A randomized trial of prednisone taper off protocol is warranted.
Patel, J.: Grant/Research Support, Alexion Pharmaceuticals. Kobashigawa, J.: Grant/Research Support, Novartis Pharma, Other, Novartis Pharma, Data Safety Monitoring Board.
To cite this abstract in AMA style:Patel J, Kittleson M, Rafiei M, Osborne A, Chang D, Czer L, Kobashigawa J. Potential Downfall of Failed Prednisone Wean after Heart Transplant [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/potential-downfall-of-failed-prednisone-wean-after-heart-transplant/. Accessed June 13, 2021.
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