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).
Grov, I., et al.Clinical Transplantation 2024; 38(11): e70028.
Aims
The aim of this follow-up study of the SCHEDULE trial was to compare health-related quality of life (HRQoL) in heart transplant patients treated long-term with everolimus (EVR) versus a calcineurin inhibitors (CNI)-based regimen.
Interventions
Participants were randomised to either the EVR group or the CNI group.
Participants
115 de novo adult heart transplant recipients.
Outcomes
The main outcomes of interest were HRQoL or predictors of HRQoL following heart transplantation, renal function, adverse events and survival.
Follow-up
12 years posttransplantation
CET Conclusions
This manuscript reports a follow-up study of the SCHEDULE trial, which randomised 115 heart transplant recipients to cyclosporine or early substitution of cyclosporine with everolimus. Quality of life was reassessed in 78 patients 10-12 years post heart transplant using generic QOL instruments. In general, improvements in physical and mental components were seen in both groups, with no differences between groups. Whilst significant differences in QOL by randomisation group are perhaps not expected, this kind of longitudinal data in a large cohort of cardiac transplant recipients provides useful insights into quality-of-life improvements seen with transplantation in the long-term. The authors use both intent-to-treat and per-protocol analyses, with no differences seen between the two.
Trial registration
ClinicalTrials.gov - NCT01266148