Clinical transplantation · 2024
The Effect of Everolimus Versus Calcineurin Inhibitors on Quality of Life 10-12 Years After Heart Transplantation: The Results of a Randomized Controlled Trial (SCHEDULE Trial).
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Grov Ingelin, Authen Anne Relbo, Arora Satish, Bergh Niklas, Rolid Katrine, Gustafsson Finn, Eiskjær Hans, Rådegran Göran, Gude Einar, Andreassen Arne K, Halden Thea, Broch Kaspar, Gullestad Lars, SCHEDULE investigators
Аннотация
BACKGROUND: Calcineurin inhibitors (CNIs) are associated with long-term complications after heart transplantation (HTx). Everolimus (EVR)-based immunosuppression allows for CNI withdrawal. We used data from The Scandinavian heart transplant everolimus de novo study with early CNI avoidance (SCHEDULE) trial to assess whether health-related quality of life (HRQoL) differed between patients on long-term treatment with EVR versus a CNI-based regimen.
METHODS: In SCHEDULE, we randomized 115 patients (mean age 51 ± 13 years, 27% women) to cyclosporine (CNI group; n = 59), or early introduction of EVR and cyclosporine withdrawal within 11 weeks of HTx (EVR group; n = 56). The primary endpoint was the glomerular filtration rate. We used the Short Form-36 (SF-36v2), the EuroQoL visual analogue scale (EQ VAS), and the Beck Depression Inventory (BDI) to assess HRQoL. We re-evaluated the participants after 10-12 years.
RESULTS: Seventy-eight patients attended follow-up at a median of 11 years after HTx. The SF-36 physical component summary score increased from 32 ± 10 pre-HTx to 44 ± 12 11 years after HTx (p < 0.01) in the EVR group and from 33 ± 9 to 44 ± 11 (p < 0.01) with CNI. The mental component summary score increased from 46 ± 12 to 53 ± 13 (EVR); p = 0.04 and from 38 ± 13 to 49 ± 13 (CNI); p < 0.01. Similar improvements were observed regarding EQ-VAS and the BDI. There were no significant between-group differences for either measure of HRQoL.
CONCLUSIONS: In heart transplant recipients, an EVR-based immunosuppressive strategy resulted in similar long-term improvements in HRQoL as treatment with a CNI-based regimen.
METHODS: In SCHEDULE, we randomized 115 patients (mean age 51 ± 13 years, 27% women) to cyclosporine (CNI group; n = 59), or early introduction of EVR and cyclosporine withdrawal within 11 weeks of HTx (EVR group; n = 56). The primary endpoint was the glomerular filtration rate. We used the Short Form-36 (SF-36v2), the EuroQoL visual analogue scale (EQ VAS), and the Beck Depression Inventory (BDI) to assess HRQoL. We re-evaluated the participants after 10-12 years.
RESULTS: Seventy-eight patients attended follow-up at a median of 11 years after HTx. The SF-36 physical component summary score increased from 32 ± 10 pre-HTx to 44 ± 12 11 years after HTx (p < 0.01) in the EVR group and from 33 ± 9 to 44 ± 11 (p < 0.01) with CNI. The mental component summary score increased from 46 ± 12 to 53 ± 13 (EVR); p = 0.04 and from 38 ± 13 to 49 ± 13 (CNI); p < 0.01. Similar improvements were observed regarding EQ-VAS and the BDI. There were no significant between-group differences for either measure of HRQoL.
CONCLUSIONS: In heart transplant recipients, an EVR-based immunosuppressive strategy resulted in similar long-term improvements in HRQoL as treatment with a CNI-based regimen.