Key take-aways
- Many cases of cardiovascular disease are preventable through early detection and intervention.
- In the DANCAVAS 2 population-based trial, being invited to undergo comprehensive cardiovascular screening did not significantly reduce the incidence of death among men aged 60 to 64 years compared with no invitation.
- A higher incidence of severe bleeding in those invited for screening suggests aspirin should be used very selectively for primary prevention.
- Further studies in women and different age groups may help to define if there is a cohort of individuals that derives mortality benefit from population-based cardiovascular screening.
Madrid, Spain – 30 August 2025: An invitation to attend a comprehensive screening examination for the early signs of cardiovascular disease (CVD) did not reduce all-cause death among men aged 60 to 64 years, according to late-breaking research presented in a Hot Line session today at ESC Congress 2025.1
It has been estimated that 80% of cardiac events and strokes are preventable, around half of these through early detection and intervention.2 Population screening is one approach to identify individuals with early signs of CVD, but there is limited evidence that it provides benefits in terms of reducing deaths.
Principal Investigator of the DANCAVAS 2 trial, Professor Axel Cosmus Pyndt Diederichsen from Odense University Hospital, Odense, Denmark, said: “We have previously shown in the population-based DANCAVAS 1 trial that while inviting men aged 65 to 74 years to undergo cardiovascular screening did not significantly reduce the incidence of death overall, there appeared to be a reduction in a subgroup of men aged 65 to 69 years.3 We designed the DANCAVAS 2 trial to investigate the effects of population-based screening in even younger men – aged between 60 and 64 years – to see if death could be significantly reduced.”
The population-based, parallel-group, randomised controlled DANCAVAS 2 trial included all men aged 60–64 years living in 18 municipalities in Denmark from August 2017 to November 2018 without any exclusion criteria. They were randomised 1:4 to receive an invitation to attend screening for subclinical CVD (the invited group) or not to receive an invitation for screening (the control group). Participants in the control group were blinded and were not aware of the trial. Intention-to-treat analyses were performed which compared control vs. all invited participants, whether or not they attended screening.
Screening included non-contrast ECG-gated computed tomography (CT) 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 hypercholesterolaemia. Statins and/or an antithrombotic agent (aspirin or clopidogrel) were prescribed based on the results of the screening tests. The primary outcome was death from any cause.
In total, 31,268 participants were randomised: 25,322 to the control arm and 5,946 to the invited arm, of whom 3,720 attended and were screened (62.6%). In total, 33.5% of the invited group initiated an antithrombotic agent compared with 15.9% in the control group, while the initiation rate of statins was 44.3% and 30.3%, respectively.
In intention-to-treat analyses, after a median follow-up of 7.0 years, 9.3% of men in the invited group and 9.9% men in the control group had died (hazard ratio [HR] 0.94; 95% confidence interval [CI] 0.86 to 1.03; p=0.169).
Major adverse cardiovascular events (CVD-related death, stroke or acute myocardial infarction) occurred in 10.2% of participants in the invited group vs. 10.6% in the control group (HR 0.96; 95% CI 0.88 to 1.04), while 1.8% of participants in both groups experienced major adverse lower limb events (HR 1.01; 95% CI 0.82 to 1.24). CVD-related death occurred in 2.1% of participants in the invited group vs. 2.3% in the control group (HR 0.92; 95% CI 0.76 to 1.11).
There was a significantly higher incidence in the invited group vs. control group of severe bleeding (6.0% vs. 5.1%; HR 1.18; 95% CI 1.05 to 1.32; p=0.007). This included intracranial bleeding (1.4% vs. 1.1%; HR 1.23; 95% CI 0.96 to 1.58; p=0.097) and gastrointestinal bleeding (4.8% vs. 4.1%; HR 1.18; 95% CI 1.03 to 1.34; p=0.014), respectively.
In post hoc per-protocol analyses, attending screening reduced mortality by 17% (95% CI 2% to 29%; p=0.029), while there was no significant difference in major adverse cardiovascular events.
Putting the findings into context, Professor Diederichsen noted: “The non-significant 6% reduction in death in men aged 60–64 years in the DANCAVAS 2 trial was less than the 11% reduction observed in the subgroup of men aged 65–69 years in the DANCAVAS 1 trial.3 The results may have been affected by those who were invited but did not attend screening. We could also speculate that screening slightly older individuals – around 67 years old – may be more beneficial. An important observation was the increase in severe bleeding seen in the invited group, which was likely due to higher aspirin intake and indicates that aspirin should be used very selectively for primary prevention in men aged 60–64 years, even in patients with coronary calcifications.” Regarding next steps, he concluded: “We included only men in DANCAVAS 2 because of a higher prevalence of screening findings in an earlier pilot study, but future population-based studies are warranted in women.”
ENDS