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Randomized Controlled Trial
. 2024 Nov;38(11):e70028.
doi: 10.1111/ctr.70028.

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)

Ingelin Grov  1 , Anne Relbo Authen  1 , Satish Arora  1 , Niklas Bergh  2   3 , Katrine Rolid  4 , Finn Gustafsson  5 , Hans Eiskjær  6 , Göran Rådegran  7 , Einar Gude  1 , Arne K Andreassen  1 , Thea Halden  8 , Kaspar Broch  1   9 , Lars Gullestad  1   9 ; SCHEDULE investigators
Affiliations
Randomized Controlled Trial

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)

Ingelin Grov et al. Clin Transplant. 2024 Nov.

Abstract

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.

Keywords: calcineurin inhibitors; cyclosporine; everolimus; health‐related quality of life; heart transplantation; immunosuppression; quality of life.

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Conflict of interest statement

This is a long‐term follow‐up study of the randomized SCHEDULE‐trial performed in collaboration with Novartis where Novartis provided some financial support. Finn Gustafsson receives advisor fees from Abbott, Bayer, Carmat, Impulse Dynamics, Novartis, and Pfizer and speaker fees from AstraZeneca, Boehringer Ingelheim, and Orion Pharma. Kaspar Broch has received lecture fees from Amgen, AstraZeneca, Bayer, Boehringer, Novartis, Novo Nordisk, Pfizer, Pharmacosmos, and Vifor Pharma. Lars Gullestad has received lecture fees from Novartis, Boehringer Ingelheim, and AstraZeneca. Einar Gude has received lecture fees from Pfizer, Merck Sharp and Dohme, and Novartis. Niklas Bergh is currently employed as Senior Medical Director at AstraZeneca, Mölndal, Sweden. Thea Halden is an employee at Novartis Norge AS. The other authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Trial participant randomization and follow‐up. ITT, intention‐to‐treat population; PP, per‐protocol population.
FIGURE 2
FIGURE 2
SF‐36 physical component score (PCS), SF‐36 mental component score (MPCS), EQ‐visual analogue scale, and Beck Depression Inventory (BDI) during the study.
See this image and copyright information in PMC

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