Everolimus Initiation and Early Calcineurin Inhibitor Withdrawal in Heart Transplant Recipients: A Randomized Trial

Andreassen, Arne K.; Andersson, Bert; Gustafsson, Finn; Eiskjær, Hans; Rådegran, Göran; Gude, Einar; Jansson, Kjell; Solbu, D.; Sigurdardottir, Vilborg; Arora, Satish; Dellgren, Göran; Gullestad, Lars

doi:10.1111/ajt.12809

Cited by 131 publications

(127 citation statements)

References 40 publications

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“…As observed at month 12 (11), echocardiography showed no differences in left ventricular dimensions or systolic function between the two treatment groups at month 36 (Table 4). Plasma levels of NT-proBNP and troponin T showed no statistically significant differences (Table 4).…”

Section: Graft Functionmentioning

confidence: 53%

“…The study design has been described in full previously (11) and is summarized in Figure S1. The current analysis was a continuation of the original SCHEDULE study.…”

Section: Methodsmentioning

confidence: 99%

“…At the end of the 12-month trial, the everolimus-treated patient cohort had significantly better renal function than the control group and significantly lower incidence of CAV, but mild to moderate acute rejection was more frequent after CNI therapy was withdrawn (11). The aim of the current analysis was to provide a longer term assessment of the effect of early everolimus initiation with CNI withdrawal on renal function and on the rate of CAV progression compared with a conventional CNI-based regimen.…”

Section: Introductionmentioning

confidence: 96%

“…In the SCHEDULE (Scandinavian heart transplant everolimus de novo study with early calcineurin inhibitors avoidance) trial, patients were randomized to everolimus with reduced CNI followed by CNI withdrawal at week [7][8][9][10][11] or to a conventional CNI-based regimen. At the end of the 12-month trial, the everolimus-treated patient cohort had significantly better renal function than the control group and significantly lower incidence of CAV, but mild to moderate acute rejection was more frequent after CNI therapy was withdrawn (11).…”

Section: Introductionmentioning

confidence: 99%

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Everolimus Initiation With Early Calcineurin Inhibitor Withdrawal in De Novo Heart Transplant Recipients: Three-Year Results From the Randomized SCHEDULE Study

Andreassen

Andersson

Gustafsson

et al. 2016

American Journal of Transplantation

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In a randomized, open‐label trial, de novo heart transplant recipients were randomized to everolimus (3–6 ng/mL) with reduced‐exposure calcineurin inhibitor (CNI; cyclosporine) to weeks 7–11 after transplant, followed by increased everolimus exposure (target 6–10 ng/mL) with cyclosporine withdrawal or standard‐exposure cyclosporine. All patients received mycophenolate mofetil and corticosteroids. A total of 110 of 115 patients completed the 12‐month study, and 102 attended a follow‐up visit at month 36. Mean measured GFR (mGFR) at month 36 was 77.4 mL/min (standard deviation [SD] 20.2 mL/min) versus 59.2 mL/min (SD 17.4 mL/min) in the everolimus and CNI groups, respectively, a difference of 18.3 mL/min (95% CI 11.1–25.6 mL/min; p < 0.001) in the intention to treat population. Multivariate analysis showed treatment to be an independent determinant of mGFR at month 36. Coronary intravascular ultrasound at 36 months revealed significantly reduced progression of allograft vasculopathy in the everolimus group compared with the CNI group. Biopsy‐proven acute rejection grade ≥2R occurred in 10.2% and 5.9% of everolimus‐ and CNI‐treated patients, respectively, during months 12–36. Serious adverse events occurred in 37.3% and 19.6% of everolimus‐ and CNI‐treated patients, respectively (p = 0.078). These results suggest that early CNI withdrawal after heart transplantation supported by everolimus, mycophenolic acid and steroids with lymphocyte‐depleting induction is safe at intermediate follow‐up. This regimen, used selectively, may offer adequate immunosuppressive potency with a sustained renal advantage.

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Section: Graft Functionmentioning

confidence: 53%

“…The study design has been described in full previously (11) and is summarized in Figure S1. The current analysis was a continuation of the original SCHEDULE study.…”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 96%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Everolimus Initiation With Early Calcineurin Inhibitor Withdrawal in De Novo Heart Transplant Recipients: Three-Year Results From the Randomized SCHEDULE Study

Andreassen

Andersson

Gustafsson

et al. 2016

American Journal of Transplantation

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show abstract

“…In this issue of the journal, Andreassen and colleagues (1) report on the Scandinavian heart transplant everolimus de novo study with early calcineurin inhibitor avoidance (SCHEDULE) Trial which randomized 115 de novo heart transplant patients to low exposure everolimus (EVL) with reduced-exposure cyclosporine (CSA; CSA withdrawn after 7-11 weeks) or standard-exposure CSA both with mycophenolate mofetil (MMF) and corticosteroids. They report that the EVL group had markedly improved renal function with attenuation of the development of cardiac allograft vasculopathy (CAV) as measured by first-year intravascular ultrasound (IVUS).…”

Section: Received and Revised 08 April 2014 Accepted For Publicationmentioning

confidence: 99%

Everolimus in Heart Transplantation: Does It Finally Have a Home?

Kobashigawa¹,

Zuckermann

2014

American Journal of Transplantation

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Cardiac Allograft Vasculopathy

Mazur,

Eisen

2023

Textbook of Transplantation and Mechanical Support for End‐Stage Heart and Lung Disease

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Everolimus Initiation and Early Calcineurin Inhibitor Withdrawal in Heart Transplant Recipients: A Randomized Trial

Cited by 131 publications

References 40 publications

Everolimus Initiation With Early Calcineurin Inhibitor Withdrawal in De Novo Heart Transplant Recipients: Three-Year Results From the Randomized SCHEDULE Study

Everolimus Initiation With Early Calcineurin Inhibitor Withdrawal in De Novo Heart Transplant Recipients: Three-Year Results From the Randomized SCHEDULE Study

Everolimus in Heart Transplantation: Does It Finally Have a Home?

Cardiac Allograft Vasculopathy

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