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North American Results from the Multicenter Randomized Trial of Everolimus vs Mycophenolate Mofetil in Heart Transplantation
Journal article   Open access   Peer reviewed

North American Results from the Multicenter Randomized Trial of Everolimus vs Mycophenolate Mofetil in Heart Transplantation

J. Kobashigawa, D. Pauly, H. Ross, A. Kfoury, A. Van Bakel, D. Patel, A. Wiland, P. Lopez, A. Balfour, R. Starling, …
The Journal of heart and lung transplantation, v 32(4), pp S201-S201
Apr 2013
DOI: https://doi.org/10.1016/j.healun.2013.01.496
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https://doi.org/10.1016/j.healun.2013.01.496View
Published, Version of Record (VoR)Maybe Open Access (Publisher Bronze),  Open

Abstract

Final 24-month (M) results of a randomized, open-label, multinational study (A2310) comparing efficacy and safety of everolimus (EVR) with mycophenolate mofetil (MMF) in de novo heart transplant recipients (HTxR) have been reported. HTxR in North America (NA) compared to Non- North America (Non) had increased incidence of diabetes, hypertension, hyperlipidemia, high body mass index; and greater ventricular assist device use and a different pattern of induction therapy use. Therefore, we studied NA outcomes for efficacy and renal function from the A2310 study. In NA, HTxR were randomized to 1.5mg (N=155) or 3mg/day (N=99) EVR (target C0: 3-8 or 6-12ng/mL) w/reduced-dose cyclosporine (rdCsA) or 3g/day MMF w/standard-dose CsA (sdCsA) (N=157) + steroids +/- induction. The EVR 3mg arm was prematurely terminated due to higher mortality. The 24M analysis assessed composite efficacy failure (CEF), renal function (eGFR) and adverse events (AE). 48% of NA HTxR (vs. 15% NON) did not receive induction therapy; and 17% NA (vs. 46% NON) received thymoglobulin. At 24M, EVR 1.5mg was comparable to MMF for CEF, but inferior for renal function. The mean difference in eGFR at 24M was -6.5mL/min (97.5% CI: -14.5, 1.4) in favor of MMF. Results were similar to the A2310 study as a whole. Despite NA differences in baseline demographics especially use of no induction and less thymoglobulin, de novo use of EVR 1.5mg + rdCsA provided good efficacy, comparable to MMF + sdCsA. Final results of this study appear to be applicable to NA heart transplant patients. Efficacy and renal function at 24M for NA patientsParameter, n (%)EVR 1.5mg (N=155)MMF (N=157)Composite efficacy failure54 (34.8)*65 (41.4)Acute rejection with hemodyamic compromise8 (5.2)10 (6.4)BPAR ≥ 3a (2R)38 (24.5)46 (29.3)Death12 (7.7)12 (7.6)Graft loss/re-transplant3 (1.9)4 (2.5)Loss to follow-up3 (1.9)8 (5.1)Mean eGFR (MDRD), mL/min/1.73m²58.765.3*<0.001 for comparability to MMF

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Collaboration types
Industry collaboration
Domestic collaboration
International collaboration
Web of Science research areas
Cardiac & Cardiovascular Systems
Respiratory System
Surgery
Transplantation
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