The Effect of Everolimus Initiation and Calcineurin Inhibitor Elimination on Cardiac Allograft Vasculopathy in De Novo Recipients: One‐Year Results of a Scandinavian Randomized Trial. Issue 7 (17th March 2015)

• Record Type: Journal Article
• Authors: Arora, S.; Andreassen, A. K.; Andersson, B.; Gustafsson, F.; Eiskjær, H.; Bøtker, H. E.; Rådegran, G.; Gude, E.; Ioanes, D.; Solbu, D.; Sigurdardottir, V.; Dellgren, G.; Erikstad, I.; Solberg, O. G.; Ueland, T.; Aukrust, P.; Gullestad, L.; on behalf of the SCHEDULE (SCandinavian HEart transplant everolimus De novo stUdy with earLy calcineurin inhibitors avoidancE) Investigators
• Is Part Of: American journal of transplantation. Volume 15:Issue 7(2015:Jul.)
• Page Start: 1967
• Page End: 1975
• Publication Date: 2015-03-17
• Subjects: Transplantation of organs, tissues, etc -- Periodicals; 617.95
• DOI: 10.1111/ajt.13214
• Languages: English
• ISSNs: 1600-6135

Abstract

<abstract abstract-type="main" xml:lang="en"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="ajt13214-sec-0001" sec-type="section"> <p>Early initiation of everolimus with calcineurin inhibitor therapy has been shown to reduce the progression of cardiac allograft vasculopathy (CAV) in <italic>de novo</italic> heart transplant recipients. The effect of <italic>de novo</italic> everolimus therapy and early total elimination of calcineurin inhibitor therapy has, however, not been investigated and is relevant given the morbidity and lack of efficacy of current protocols in preventing CAV. This 12‐month multicenter Scandinavian trial randomized 115 <italic>de novo</italic> heart transplant recipients to everolimus with complete calcineurin inhibitor elimination 7–11 weeks after HTx or standard cyclosporine immunosuppression. Ninety‐five (83%) patients had matched intravascular ultrasound examinations at baseline and 12 months. Mean (± SD) recipient age was 49.9 ± 13.1 years. The everolimus group (n = 47) demonstrated significantly reduced CAV progression as compared to the calcineurin inhibitor group (n = 48) (ΔMaximal Intimal Thickness 0.03 ± 0.06 and 0.08 ± 0.12 mm, ΔPercent Atheroma Volume 1.3 ± 2.3 and 4.2 ± 5.0%, ΔTotal Atheroma Volume 1.1 ± 19.2 mm<sup>3</sup> and 13.8 ± 28.0 mm<sup>3</sup> [all p‐values ≤ 0.01]). Everolimus patients also had a significantly greater decline in levels of soluble tumor necrosis factor receptor‐1 as compared to the calcineurin inhibitor group (p = 0.02). These preliminary results suggest that an everolimus‐based CNI‐free can potentially be considered in suitable <italic>de novo</italic> HTx recipients.</p> </sec> </abstract>