DANCAVAS 2 and ABC-AF Trials Explore Personalized Treatments For CV Prevention

New research exploring the potential of personalized treatments to detect and prevent cardiovascular disease was part of a prevention-focused hot line Session at ESC Congress 2025.

In the population-based DANCAVAS 2 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.

Researchers randomized 31,268 men in a 1:4 ratio to receive an invitation to attend screening for subclinical cardiovascular disease or not. Of the invited group, 3,720 attended and were screened (62.6%).

Screening included non-contrast ECG-gated 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 hypercholesterolemia. 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, study investigators said 33.5% of the invited group initiated an antithrombotic agent compared with 15.9% in the control group. The initiation rate of statins was 44.3% and 30.3% in the invited group vs. the control group, respectively. After a median follow-up of 7, 9.3% of men in the invited group compared with 9.9% of the men in the control group had died. The percentages of major adverse cardiovascular events and cardiovascular disease-related death were similar across both groups. However, researchers observed a significantly higher incidence of severe bleeding in the invited group vs. control group (6.0% vs. 5.1%).

"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," said Principal Investigator Axel Cosmus Pyndt Diederichsen, PhD. "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."

He added that further studies in women and different age groups may help to define if there is a cohort of individuals that derives mortality benefit from this population-based cardiovascular screening.

In the ABC-AF trial, researchers evaluated whether tailoring of treatment recommendations based on patients' ABC-AF risk scores could improve clinical outcomes as compared with usual guideline-based care. "While novel biomarker-based risk scores have been validated in different populations, the clinical utility of risk scores to guide treatment decisions and improve clinical outcomes has rarely been prospectively evaluated," said Principal Investigator Jonas Oldgren, MD, PhD.

Researchers randomized 3,933 patients in Sweden (median age of 74 years/33.6% women) to either an ABC-AF risk score-guided treatment strategy or to standard of care. Enrollment was prematurely terminated owing to safety concerns with a trend towards higher mortality in patients with CHA2DS2-VASc scores of >3.

Over a median follow-up of 2.6 years, the primary outcome – a composite of stroke or death – occurred at a similar rate between the groups. Broken out, there were also no significant differences between the two groups in terms of stroke rate, death or major bleeding events.

"We found no benefit of individually tailored, multidimensional treatment recommendations based on ABC-AF-stroke and ABC-AF-bleeding risk scores compared with usual guideline-based care in this study population who had lower-than-expected event rates," said Oldgren. "Due to premature termination of recruitment, the study was underpowered for its primary objective, but we will continue to follow-up randomized patients to assess any long-term effects."

Resources

Clinical Topics: Arrhythmias and Clinical EP, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: ESC Congress, ESC25, Secondary Prevention, Arrhythmias, Cardiac