Cardiovascular Parameters to 2 years After Kidney Transplantation Following Early Switch to Everolimus Without Calcineurin Inhibitor Therapy: An Analysis of the Randomized ELEVATE Study.

Background: Mammalian target of rapamycin (mTOR) inhibitors may confer cardioprotective advantages but clinical data are limited. Methods: In the open-label ELEVATE trial, kidney transplant patients were randomized at 10-14 weeks posttransplant to convert from calcineurin inhibitor (CNI) to everolimus or remain on standard CNI therapy. Prespecified endpoints included left ventricular mass index (LVMi) and, in a subpopulation of patients, arterial stiffness as measured by pulse wave velocity (PWV). Results: The mean change in LVMi from randomization was similar with everolimus versus CNI (month 24: -4.37 g/m2.7 versus -5.26 g/m2.7; mean difference 0.89 [p=0.392]). At month 24, LVH was present in 41.7% versus 37.7% of everolimus and CNI patients, respectively. Mean PWV remained stable with both everolimus (mean change from randomization to month 12: -0.24 m/s; month 24: -0.03 m/s) or CNI (month 12: 0.11 m/s; month 24: 0.16 m/s). The change in mean ambulatory night time blood pressure from randomization showed a benefit for diastolic pressure at month 12 (p=0.039) but not month 24. Major adverse cardiac events occurred in 1.1% and 4.2% of everolimus-treated and CNI-treated patients, respectively by month 12 (p=0.018) and 2.3% (8/353) and 4.5% by month 24 (p=0.145). Conclusions: Overall, these data do not suggest a clinically relevant effect on cardiac endpoints following early conversion from CNI to a CNI-free everolimus-based regimen. Copyright (C) 2017 Wolters Kluwer Health, Inc. All rights reserved.

http://ift.tt/2nXPLgZ