Open AccessLong‐term outcomes of thoracic transplant recipients following conversion to everolimus with reduced calcineurin inhibitor in a multicenter, open‐label, randomized trial
Author(s) -
Gullestad Lars,
Eiskjaer Hans,
Gustafsson Finn,
Riise Gerdt C.,
Karason Kristjan,
Dellgren Göran,
Rådegran Göran,
Hansson Lennart,
Gude Einar,
Bjørtuft Øystein,
Jansson Kjell,
Schultz Hans Henrik,
Solbu Dag,
Iversen Martin
Publication year - 2016
Publication title -
transplant international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.998
H-Index - 82
eISSN - 1432-2277
pISSN - 0934-0874
DOI - 10.1111/tri.12783
Subject(s) - everolimus , medicine , calcineurin , randomization , urology , renal function , lung transplantation , heart transplantation , transplantation , randomized controlled trial , surgery , gastroenterology
Summary The NOCTET study randomized 282 patients ≥1 year after heart or lung transplantation to continue conventional calcineurin inhibitor (CNI) therapy or to start everolimus with reduced‐exposure CNI. Last follow‐up, at ≥5 years postrandomization (mean: 5.6 years) was attended by 72/140 everolimus patients (51.4%) and 91/142 controls (64.1%). Mean measured GFR remained stable in the everolimus group from randomization (51.3 ml/min) to last visit (51.4 ml/min) but decreased in controls (from 50.5 ml/min to 45.3 ml/min) and was significantly higher with everolimus at last follow‐up ( P = 0.004). The least squares mean (SE) change from randomization was −1.5 (1.7)ml/min with everolimus versus −7.2 (1.7)ml/min for controls (difference: 5.7 [95% CI 1.7; 9.6]ml/min; P = 0.006). The difference was accounted for by heart transplant patients (difference: 6.9 [95% 2.3; 11.5]ml/min; P = 0.004). Lung transplant patients showed no between‐group difference at last follow‐up. Rates of rejection, death, and major cardiac events were similar between groups, as was graft function. Pneumonia was more frequent with everolimus (18.3% vs. 6.4%). In conclusion, introducing everolimus in maintenance heart transplant patients, with reduced CNI, achieves a significant improvement in renal function which is maintained for at least 5 years, but an early renal benefit in lung transplant patients was lost. Long‐term immunosuppressive efficacy was maintained.