Effect of Everolimus on Cardiovascular Parameters in De Novo Kidney Transplant Recipients: 12-Month Results from the ELEVATE Study

H. Holdaas,¹ M. van der Giet,¹ J. de Fijter,¹ A. Speziale,² C. Escrig,² G. Junge,² Z. Wang,³ J. Cruzado.¹

¹For the ELEVATE Study, Oslo, Norway
²Novartis, Basel, Switzerland
³Novartis Corporation, East Hanover, NJ.

Meeting: 2015 American Transplant Congress

Abstract number: A174

Keywords: Immunosuppression, Kidney transplantation

Session Information

Session Name: Poster Session A: Kidney: Cardiovascular and Metabolic

Session Type: Poster Session

Date: Saturday, May 2, 2015

Session Time: 5:30pm-7:30pm

Presentation Time: 5:30pm-7:30pm

Location: Exhibit Hall E

Background: Long-term exposure to calcineurin inhibitors (CNIs) contributes to an unfavorable cardiovascular (CV) risk profile, including inferior renal allograft function and premature graft loss with vascular lesions, glomerulosclerosis and, interstitial fibrosis and tubular atrophy (IF/TA). We present here the 12-month (M12) data on CV parameters from the ELEVATE study (NCT01114529), which compared an early switch from a CNI to everolimus (EVR)-based regimen with continued CNI therapy in de novo kidney transplant recipients (KTxR) vs standard CNI.

Methods: In this 24M, multicenter, open-label study, de novo KTxR were randomized (RND) after 10-14 weeks to EVR (C0 6–10g/mL) or continued standard CNI (C0, tacrolimus: 5–10ng/mL, cyclosporine: 100–250ng/mL); all patients received enteric-coated mycophenolate sodium and steroids. Change in arterial pulse wave velocity (PWV) from RND to M12 was assessed by pulse wave blood monitoring. In addition, 24-hour blood pressure monitoring was also performed. Here we present data of patients for which both RND and M12 LVMi values were available.

Results: Overall, mean PWV at RND for all patients was assessed in 94 EVR (7.81m/s) and 123 CNI patients (7.64m/s). At M12, mean PWV (m/s) for all patients changed to 7.55 for EVR (n=84) and 7.73 for CNI (n=115). For patients with LVH, mean PWV was assessed in 47 EVR (40.42% concentric and 59.58% eccentric) and 68 CNI (48.53% concentric and 51.47% eccentric) patients at RND, and in 40 EVR (40% concentric and 60% eccentric) and 63 CNI (46.03% concentric and 53.97% eccentric) patients at M12. For patients with LVH, difference between the mean PWV (m/s) was -0.33 in EVR and +0.12 in CNI groups. The stratification by concentric and eccentric LVH showed greater change in pulse wave velocity in EVR vs CNI groups for concentric LVH (difference between mean: -1.07m/s vs +0.35m/s), while marginal changes were observed for the eccentric LVH (difference in mean: +0.14m/s vs -0.07m/s). No significant difference was noted with both systolic and diastolic blood pressure across the groups.

Conclusion: Nine months after CNI conversion, these analyses show a favorable trend in vascular flexibility with EVR compared with CNI. Blood pressure, a known modulator for PWV, showed no changes between the two treatment groups.

To cite this abstract in AMA style:

Holdaas H, Giet Mvander, Fijter Jde, Speziale A, Escrig C, Junge G, Wang Z, Cruzado J. Effect of Everolimus on Cardiovascular Parameters in De Novo Kidney Transplant Recipients: 12-Month Results from the ELEVATE Study [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/effect-of-everolimus-on-cardiovascular-parameters-in-de-novo-kidney-transplant-recipients-12-month-results-from-the-elevate-study/. Accessed May 16, 2025.

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