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DANCAVAS: Universal CVD Screenings Do Not Reduce Risk of Death in Men

New research suggests increased screenings for subclinical cardiovascular disease did not significantly reduce the risk of mortality in men aged 65-74 years.

A population-based trial of men aged 65-74 years living in 15 Danish municipalities, results of the DANCAVAS trial, which were presented at the European Society of Cardiology (ESC) Congress 2022, suggest an invitation to participate in comprehensive cardiovascular screenings did not significantly reduce the risk of all-cause mortality during a follow-up period lasting a median of 5.6 years.

“Despite remarkable reductions in mortality from cardiovascular disease, it remains the leading cause of death. More than half of cardiovascular disease is avoidable, meaning that successful prevention has a huge potential to improve public health. DANCAVAS investigated whether screening, including imaging, for seven cardiovascular conditions, and treatment if indicated, could prevent death and cardiovascular disease," said Professor Axel Diederichsen, of Odense University Hospital, in a statement.

With a recent emphasis placed on further identification of patients at increased risk who may benefit for further preventive treatments, the Danish Cardiovascular Screening (DANCAVAS) trial was designed as a multicenter, parallel-group, randomized, controlled trial with the intent of comparing outcomes in participants who were invited to undergo comprehensive cardiovascular screening versus a control group of participants who were not invited. With enrollment beginning in September 2014 and concluding in September 2017, investigators enrolled 46,611 men 65-74 years of age living in 15 municipalities in the southern and central regions of Denmark.

In a 1:2 ratio, these individuals were randomized to be invited to undergo a comprehensive screening or not invited for screening of subclinical cardiovascular disease. The screening included noncontrast electrocardiography-gated computed tomography to determine the CAC 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 of interest for the trial was the incidence of all-cause mortality, with outcomes data for the trial were derived from the Danish National Patient Registry and the Danish National Prescription Registry.

After exclusion of 85 men who died or emigrated before being invited to undergo screening, cohorts of 16,736 and 29,790 men were randomized to receive an invitation for screening and to the control group, respectively. Of the 16,736 individuals invited to undergo screening,62.6% (n=10,471) underwent screening. Investigators noted an additional study in women is underway, but power is limited due to the lower prevalence of clinically significant findings on screening and lower incidence of cardiovascular disease.

In intention-to-treat analyses, 12.6% (n=2106) of the invited group and 13.1% (n=3915) of the control group had died during a median follow-up of 5.6 years (HR, 0.95 [95% CI, 0.90-1.00]; P=.06). Further analysis indicated the cumulative incidence of death at 5 years was 10.6% among those who underwent screening compared to 10.9% among those who did not. In analyses stratified by age, investigators noted a greater effect of screening observed for those aged 65-69 years of age, with an 11% reduction in risk of all-cause mortality (HR, 0.89 [95% CI, 0.83-0.96]; P=.004). When assessing other outcomes of interest, investigators observed a hazard ratio of 0.93 (95% CI, 0.86-0.99) for stroke, 0.91 (95% CI, 0.81-1.03) for myocardial infarction, 0.95 (95% CI, 0.61-1.49) for aortic dissection, 0.81 (95% CI, 0.49-1.35) for aortic rupture, and 0.93 (95% CI, 0.89-0.97) for a composite outcome of death, stroke, or myocardial infarction.

In safety and ethical outcome analyses, there were no significant differences observed for the invited group and control group for safety outcomes, including incense of cancer. Investigators also pointed out there was no apparent harm of screening with repost to quality of life, but severe bleeding appeared to be more common in the invited group (6.8% and 6.3%; P=.06).

“We observed a substantial reduction in the combined endpoint of death, stroke or myocardial infarction in elderly men by comprehensive cardiovascular screening. Our results point quite firmly at a screening target age below 70 years," Diederichsen added.

This study, “Five-Year Outcomes of the Danish Cardiovascular Screening (DANCAVAS) Trial,” was presented at ESC Congress 22 and simultaneously published in the New England Journal of Medicine.