Everolimus initiation and early calcineurin inhibitor withdrawal in heart transplant recipients: a randomized trial.

Andreassen, A K; Andersson, B; Gustafsson, F; Eiskjaer, H; Radegran, G; Gude, E; Jansson, K; Solbu, D; Sigurdardottir, Vilborg; Arora, S; Dellgren, G; Gullestad, L (2014). Everolimus initiation and early calcineurin inhibitor withdrawal in heart transplant recipients: a randomized trial. American journal of transplantation, 14(8), pp. 1828-1838. Wiley-Blackwell 10.1111/ajt.12809

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In a randomized, open-label trial, everolimus was compared to cyclosporine in 115 de novo heart transplant recipients. Patients were assigned within 5 days posttransplant to low-exposure everolimus (3–6 ng/mL) with reduced-exposure cyclosporine (n = 56), or standard-exposure cyclosporine (n = 59), with both mycophenolate mofetil and corticosteroids. In the everolimus group, cyclosporine was withdrawn after 7–11 weeks and everolimus exposure increased (6–10 ng/mL). The primary efficacy end point, measured GFR at 12 months posttransplant, was significantly higher with everolimus versus cyclosporine (mean ± SD: 79.8 ± 17.7 mL/min/1.73 m2 vs. 61.5 ± 19.6 mL/min/1.73 m2; p < 0.001). Coronary intravascular ultrasound showed that the mean increase in maximal intimal thickness was smaller (0.03 mm [95% CI 0.01, 0.05 mm] vs. 0.08 mm [95% CI 0.05, 0.12 mm], p = 0.03), and the incidence of cardiac allograft vasculopathy (CAV) was lower (50.0% vs. 64.6%, p = 0.003), with everolimus versus cyclosporine at month 12. Biopsy-proven acute rejection after weeks 7–11 was more frequent with everolimus (p = 0.03). Left ventricular function was not inferior with everolimus versus cyclosporine. Cytomegalovirus infection was less common with everolimus (5.4% vs. 30.5%, p < 0.001); the incidence of bacterial infection was similar. In conclusion, everolimus-based immunosuppression with early elimination of cyclosporine markedly improved renal function after heart transplantation. Since postoperative safety was not jeopardized and development of CAV was attenuated, this strategy may benefit long-term outcome.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Sigurdardottir, Vilborg

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1600-6135

Publisher:

Wiley-Blackwell

Language:

English

Submitter:

Vilborg Sigurdardottir

Date Deposited:

25 Feb 2016 11:40

Last Modified:

25 Feb 2016 12:56

Publisher DOI:

10.1111/ajt.12809

PubMed ID:

25041227

BORIS DOI:

10.7892/boris.76005

URI:

https://boris.unibe.ch/id/eprint/76005

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