Evidence map›Paper›PMID 38739644›Full record

Trial reportPLoS medicine2024

User-defined outcomes of the Danish cardiovascular screening (DANCAVAS) trial: A post hoc analyses of a population-based, randomised controlled trial.

Axel Cosmus Pyndt Diederichsen, Anna Mejldal, Rikke Søgaard, Jesper Hallas, Jess Lambrechtsen, Flemming Hald Steffensen, Lars Frost, Kenneth Egstrup, Martin Busk, Grazina Urbonaviciene and 3 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in PLoS medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–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 synthesis or guideline pooled it.

  1. Pooled it
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

13 authors.

Axel Cosmus Pyndt DiederichsenDepartment of Cardiology, Odense University Hospital, Odense, Denmark.ORCID 0000-0002-1285-4826
Anna MejldalOpen Patient Data Explorative Network, Department of Clinical Research, Odense University Hospital, Odense, Denmark.ORCID 0000-0002-4612-4338
Rikke SøgaardElite Research Centre for Individualised Medicine, Odense University Hospital, Odense, Denmark.
Jesper HallasDepartment of Clinical Pharmacology, University of Southern Denmark, Odense, Denmark.ORCID 0000-0002-8097-8708
Jess LambrechtsenDepartment of Cardiology, Svendborg Hospital, Svendborg, Denmark.ORCID 0000-0002-9976-9981
Flemming Hald SteffensenDepartment of Cardiology, Lillebaelt Hospital, Vejle, Denmark.ORCID 0000-0003-0252-6631
Lars FrostDepartment of Cardiology, Regional Hospital Central Jutland, Silkeborg, Denmark.ORCID 0000-0001-9215-9796
Kenneth EgstrupDepartment of Cardiology, Svendborg Hospital, Svendborg, Denmark.
Martin BuskDepartment of Cardiology, Lillebaelt Hospital, Vejle, Denmark.
Grazina UrbonavicieneDepartment of Cardiology, Regional Hospital Central Jutland, Silkeborg, Denmark.
Marek KaronDepartment of Medicine, Nykøbing Falster Hospital, Nykøbing Falster, Denmark.ORCID 0000-0002-7592-1256
Lars Melholt RasmussenDepartment of Clinical Biochemistry and Pharmacology, Odense University Hospital, Odense, Denmark.ORCID 0000-0001-5795-4794
Jes Sanddal LindholtDepartment of Cardiothoracic and Vascular Surgery, Odense University Hospital, Odense, Denmark.ORCID 0000-0001-9536-4488

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Danish cardiovascular screening (DANCAVAS) trial, a nationwide trial designed to investigate the impact of cardiovascular screening in men, did not decrease all-cause mortality, an outcome decided by the investigators. However, the target group may have varied preferences. In this study, we aimed to evaluate whether men aged 65 to 74 years requested a CT-based cardiovascular screening examination and to assess its impact on outcomes determined by their preferences. METHODS AND

findingsThis is a post hoc study of the randomised DANCAVAS trial. All men 65 to 74 years of age residing in specific areas of Denmark were randomised (1:2) to invitation-to-screening (16,736 men, of which 10,471 underwent screening) or usual-care (29,790 men). The examination included among others a non-contrast CT scan (to assess the coronary artery calcium score and aortic aneurysms). Positive findings prompted preventive treatment with atorvastatin, aspirin, and surveillance/surgical evaluation. The usual-care group remained unaware of the trial and the assignments. The user-defined outcome was based on patient preferences and determined through a survey sent in January 2023 to a random sample of 9,095 men from the target group, with a 68.0% response rate (6,182 respondents). Safety outcomes included severe bleeding and mortality within 30 days after cardiovascular surgery. Analyses were performed on an intention-to-screen basis. Prevention of stroke and myocardial infarction was the primary motivation for participating in the screening examination. After a median follow-up of 6.4 years, 1,800 of 16,736 men (10.8%) in the invited-to-screening group and 3,420 of 29,790 (11.5%) in the usual-care group experienced an event (hazard ratio (HR), 0.93 (95% confidence interval (CI), 0.88 to 0.98; p = 0.010); number needed to invite at 6 years, 148 (95% CI, 80 to 986)). A total of 324 men (1.9%) in the invited-to-screening group and 491 (1.7%) in the usual-care group had an intracranial bleeding (HR, 1.17; 95% CI, 1.02 to 1.35; p = 0.029). Additionally, 994 (5.9%) in the invited-to-screening group and 1,722 (5.8%) in the usual-care group experienced severe gastrointestinal bleeding (HR, 1.02; 95% CI, 0.95 to 1.11; p = 0.583). No differences were found in mortality after cardiovascular surgery. The primary limitation of the study is that exclusive enrolment of men aged 65 to 74 renders the findings non-generalisable to women or men of other age groups.

conclusionIn this comprehensive population-based cardiovascular screening and intervention program, we observed a reduction in the user-defined outcome, stroke and myocardial infarction, but entail a small increased risk of intracranial bleeding.

trial registrationISRCTN Registry number, ISRCTN12157806 https://www.isrctn.com/ISRCTN12157806.

Indexed as

Cardiovascular DiseasesMass ScreeningAgedDenmarkHumansMaleTomography, X-Ray Computed

Identifiers

PMID38739644
PMCPMC11132442

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.