DANCAVAS 2: Invitation to screening alone is not sufficient for outcome benefit

An invitation to cardiovascular screening did not reduce all-cause mortality in men aged 60-64. However, the study found that screening invitations were linked to an increased risk of major bleeding, likely driven by the administration of aspirin among screened patients.

The DANCAVAS 2 trial (NCT03946410) randomised 31,268 Danish men aged 60-64 in a 1:4 ratio to an invitation for cardiovascular screening or no invitation. The screening comprised an ECG-gated non-contrast CT scan, four-limb blood pressure measurements, and blood sampling. The primary outcome was all-cause mortality. Prof. Axel Diederichsen (University of Southern Denmark, Denmark) presented the key findings.

After 7 years of follow-up, there was no difference in all-cause mortality between the invited group (9.33%) and the non-invited group (9.91%; HR 0.94; 95% CI 0.86-1.03; P=0.17) [1]. There was, however, an increased risk of major bleeding among participants in the invitation group (HR 1.18; 95% CI 1.05-1.32; P=0.007). “This elevated bleeding risk is likely caused by aspirin prescription among screened participants,” explained Prof. Diederichsen.

The per-protocol analysis, which included only individuals who actually underwent screening, showed an absolute risk reduction of 0.9% and a relative risk reduction of 17% in all-cause mortality compared with participants who did not undergo screening (95% CI 2%-29%). Nevertheless, this analysis revealed an increased absolute risk of 1.4% and a relative risk of 37% (95% CI, 16%-61%) of major bleeding in those who underwent screening.

“Invitation to cardiovascular screening did not reduce all-cause mortality among men aged 60-64,” concluded Prof. Diederichsen. “We did, however, observe an increase in major bleedings in the invitation group, indicating that we need to be careful with the administration of aspirin.” Notably, bleeding in the per-protocol analysis was also associated with a reduction in all-cause mortality.

1. Diederichsen ACP, et al. DANCAVAS 2: Screening and intervention to prevent cardiovascular disease and death. Hotline 5, ESC Congress 2025, 29 August – 1 September, Madrid, Spain.

Copyright ©2025 Medicom Publishing Group

 



Posted on 7 November 202510 November 2025