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Original ArticleFree Preview

Five-Year Outcomes of the Danish Cardiovascular Screening (DANCAVAS) Trial

List of authors.
  • Jes S. Lindholt, M.D., D.M.Sc.,
  • Rikke Søgaard, Ph.D.,
  • Lars M. Rasmussen, M.D., D.M.Sc.,
  • Anne Mejldal, Ph.D.,
  • Jess Lambrechtsen, Ph.D.,
  • Flemming H. Steffensen, Ph.D.,
  • Lars Frost, M.D., D.M.Sc.,
  • Kenneth Egstrup, M.D., D.M.Sc.,
  • Grazina Urbonaviciene, Ph.D.,
  • Martin Busk, Ph.D.,
  • and Axel Cosmus Pyndt Diederichsen, Ph.D.

Abstract

Background

Limited data suggest a benefit of population-based screening for cardiovascular disease with respect to the risk of death.

Methods

We performed a population-based, parallel-group, randomized, controlled trial involving men 65 to 74 years of age living in 15 Danish municipalities. The participants were randomly assigned in a 1:2 ratio to undergo screening (the invited group) or not to undergo screening (the control group) for subclinical cardiovascular disease. Randomization was based on computer-generated random numbers and stratified according to municipality. Only the control group was unaware of the trial-group assignments. Screening included noncontrast electrocardiography-gated computed tomography to determine the coronary-artery calcium score and to detect aneurysms and atrial fibrillation, ankle–brachial blood-pressure measurements to detect peripheral artery disease and hypertension, and a blood sample to detect diabetes mellitus and hypercholesterolemia. The primary outcome was death from any cause.

Results

A total of 46,611 participants underwent randomization. After exclusion of 85 men who had died or emigrated before being invited to undergo screening, there were 16,736 men in the invited group and 29,790 men in the control group; 10,471 of the men in the invited group underwent screening (62.6%). In intention-to-treat analyses, after a median follow-up of 5.6 years, 2106 men (12.6%) in the invited group and 3915 men (13.1%) in the control group had died (hazard ratio, 0.95; 95% confidence interval [CI], 0.90 to 1.00; P=0.06). The hazard ratio for stroke in the invited group, as compared with the control group, was 0.93 (95% CI, 0.86 to 0.99); for myocardial infarction, 0.91 (95% CI, 0.81 to 1.03); for aortic dissection, 0.95 (95% CI, 0.61 to 1.49); and for aortic rupture, 0.81 (95% CI, 0.49 to 1.35). There were no significant between-group differences in safety outcomes.

Conclusions

After more than 5 years, the invitation to undergo comprehensive cardiovascular screening did not significantly reduce the incidence of death from any cause among men 65 to 74 years of age. (Funded by the Southern Region of Denmark and others; DANCAVAS ISRCTN Registry number, ISRCTN12157806.)

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Funding and Disclosures

Supported by the Southern Region of Denmark, the Danish Heart Foundation, and the Danish Independent Research Councils.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

This article was published on August 27, 2022, at NEJM.org.

A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.

Author Affiliations

From the Departments of Cardiac, Thoracic, and Vascular Surgery (J.S.L., R.S.), Clinical Biochemistry and Pharmacology (L.M.R.), and Cardiology (A.C.P.D.), Elite Research Center for Individualized Medicine in Arterial Diseases, and the Open Patient Data Explorative Network (A.M.), Odense University Hospital, Clinical Institute, University of Southern Denmark (R.S.), Odense, the Department of Cardiology, Odense University Hospital, Svendborg (J.L., K.E.), the Department of Cardiology, Lillebaelt Hospital, Vejle (F.H.S., M.B.), and the Department of Cardiology, Diagnostic Center, Regional Hospital Silkeborg, Silkeborg (L.F., G.U.) — all in Denmark.

Dr. Lindholt can be contacted at or at the Department of Cardiac, Thoracic, and Vascular Surgery, Odense University Hospital, J.B. Winsløv Vej 4, DK-5000 Odense, Denmark.