Evidence map›Paper›PMID 39575520›Full record

Trial reportClinical transplantation2024

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, Anne Relbo Authen, Satish Arora, Niklas Bergh, Katrine Rolid, Finn Gustafsson, Hans Eiskjær, Göran Rådegran, Einar Gude, Arne K Andreassen and 4 more

Abstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Clinical transplantation, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Ingelin GrovDepartment of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Anne Relbo AuthenDepartment of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Satish AroraDepartment of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.ORCID https://orcid.org/0000-0002-1743-9293
Niklas BerghDepartment of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
Katrine RolidThe Research Council of Norway, Lysaker, Norway.
Finn GustafssonDepartment of Cardiology, Copenhagen University Hospital, Copenhagen, Denmark.
Hans EiskjærDepartment of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Göran RådegranThe Haemodynamic Lab, The section for Heart Failure and Valvular Disease, VO. Heart and Lung Medicine, Department of Clinical Sciences Lund, Cardiology, Skåne University Hospital, Lund University, Lund, Sweden.
Einar GudeDepartment of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Arne K AndreassenDepartment of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Thea HaldenNovartis Norge AS, Oslo, Norway.
Kaspar BrochDepartment of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Lars GullestadDepartment of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.ORCID https://orcid.org/0000-0002-5932-6641
SCHEDULE investigators

Funding

Novartis Norway
6 · The paper itself

Abstract

backgroundCalcineurin 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.

methodsIn 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.

resultsSeventy-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.

conclusionsIn heart transplant recipients, an EVR-based immunosuppressive strategy resulted in similar long-term improvements in HRQoL as treatment with a CNI-based regimen.

Indexed as

Calcineurin InhibitorsEverolimusHeart TransplantationImmunosuppressive AgentsAdultFemaleFollow-Up StudiesGlomerular Filtration RateGraft RejectionGraft SurvivalHumansMaleMiddle AgedPostoperative ComplicationsPrognosisQuality of LifeCalcineurin InhibitorsEverolimusImmunosuppressive Agentscalcineurin inhibitorscyclosporineeverolimushealth‐related quality of lifeheart transplantationimmunosuppressionquality of life

Identifiers

PMID39575520
PMCPMC11582939

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.