Hot Line 5: DANCAVAS 2
31 Aug 2025
Hot Line ESC Congress 2025 No reduction in death following an invitation to undergo comprehensive CV screening in men aged 60 to 64 years
Professor Axel Diederichsen (Odense University Hospital - Odense, Denmark) explained: “We have previously shown in the population-based DANCAVAS trial that while inviting men aged 65 to 74 years to undergo cardiovascular (CV) 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.1 The DANCAVAS 2 trial investigated population-based screening in even younger men – aged between 60 and 64 years – to see if death could be significantly reduced.”
All men aged 60–64 years living in 18 municipalities in Denmark were randomised 1:4 to receive an invitation to attend screening for subclinical CV disease (CVD) (invited group) or not to receive an invitation for screening (control group). Participants in the control group were not aware of the trial. Intention-to-treat (ITT) analyses were performed which compared control vs. all invited participants, whether or not they attended screening. Screening included non-contrast ECG-gated CT for coronary-artery calcium, aneurysms and atrial fibrillation detection, and ankle-brachial blood-pressure, circulating lipids and HbA1c measurements. Statins and/or antithrombotics were prescribed where appropriate. 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%). An antithrombotic was initiated in 33.5% of the invited group vs. 15.9% in the control group, while the statin initiation rate was 44.3% and 30.3%, respectively.
In ITT analyses, after a median follow-up of 7.0 years, 9.3% of men in the invited group and 9.9% of men in the control group had died (hazard ratio [HR] 0.94; 95% CI 0.86 to 1.03; p=0.169).
Major adverse CV 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). 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%; p=0.097) and gastrointestinal bleeding (4.8% vs. 4.1%; p=0.014).
Putting the findings into context, Prof. Diederichsen noted: “The non-significant 6% mortality reduction in men aged 60–64 years in DANCAVAS 2 was less than the 11% reduction observed in the subgroup aged 65–69 years in DANCAVAS.1 The results may have been affected by those who were invited but did not attend screening. An important observation was the increase in severe bleeding 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.”
References
- Lindholt JS, et al. N Engl J Med. 2022;387:1385–1394.
