Everolimus Versus Mycophenolate Mofetil in Heart Transplantation: A Randomized, Multicenter Trial

Eisen, H. J. and Kobashigawa, J. and Starling, R. C. and Pauly, D. F. and Kfoury, A. and Ross, H. and Wang, S. -S. and Cantin, B. and Van Bakel, A. and Ewald, G. and Hirt, S. and Lehmkuhl, H. and Keogh, A. and Rinaldi, M. and Potena, L. and Zuckermann, A. and Dong, G. and Cornu-Artis, C. and Lopez, P. (2013) Everolimus Versus Mycophenolate Mofetil in Heart Transplantation: A Randomized, Multicenter Trial. AMERICAN JOURNAL OF TRANSPLANTATION, 13 (5). pp. 1203-1216. ISSN 1600-6135, 1600-6143

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Abstract

In an open-label, 24-month trial, 721 de novo heart transplant recipients were randomized to everolimus 1.5 mg or 3.0 mg with reduced-dose cyclosporine, or mycophenolate mofetil (MMF) 3 g/day with standard-dose cyclosporine (plus corticosteroids +/- induction). Primary efficacy endpoint was the 12-month composite incidence of biopsy-proven acute rejection, acute rejection associated with hemodynamic compromise, graft loss/retransplant, death or loss to follow-up. Everolimus 1.5 mg was noninferior to MMF for this endpoint at month 12 (35.1% vs. 33.6%; difference 1.5% [97.5% CI: 7.5%, 10.6%]) and month 24. Mortality to month 3 was higher with everolimus 1.5 mg versus MMF in patients receiving rabbit antithymocyte globulin (rATG) induction, mainly due to infection, but 24-month mortality was similar (everolimus 1.5 mg 10.6% [30/282], MMF 9.2% [25/271]). Everolimus 3.0 mg was terminated prematurely due to higher mortality. The mean (SD) 12-month increase in maximal intimal thickness was 0.03 (0.05) mm with everolimus 1.5 mg versus 0.07 (0.11) mm with MMF (p < 0.001). Everolimus 1.5 mg was inferior to MMF for renal function but comparable in patients achieving predefined reduced cyclosporine trough concentrations. Nonfatal serious adverse events were more frequent with everolimus 1.5 mg versus MMF. Everolimus 1.5 mg with reduced-dose cyclosporine offers similar efficacy to MMF with standard-dose cyclosporine and reduces intimal proliferation at 12 months in de novo heart transplant recipients.

Item Type: Article
Uncontrolled Keywords: CARDIAC ALLOGRAFT VASCULOPATHY; CYTOMEGALOVIRUS-INFECTION; INTERNATIONAL SOCIETY; LUNG TRANSPLANTATION; ACUTE REJECTION; RECIPIENTS; CYCLOSPORINE; NOMENCLATURE; PREVENTION; SIROLIMUS; Cardiac allograft vasculopathy; cyclosporine; everolimus; heart transplantation; mycophenolate mofetil; randomized
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Herz-, Thorax- und herznahe Gefäßchirurgie
Depositing User: Dr. Gernot Deinzer
Date Deposited: 15 Apr 2020 13:17
Last Modified: 15 Apr 2020 13:17
URI: https://pred.uni-regensburg.de/id/eprint/16734

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