Outcomes of cardiovascular screening in men aged 60–64 years: the DANCAVAS II trial

Background and aims Limited data suggest a benefit of population-based screening for cardiovascular disease (CVD) with respect to mortality. Methods A population-based, parallel-randomized controlled trial of Danish men aged 60-64 years randomized 1:4 to invitation to screening for subclinical CVD or no invitation (control group) were performed. Allocation was based on computer-generated random numbers and stratified on municipality. Only the control group was blinded. The screening included coronary artery calcification score, aneurysms, atrial fibrillation, peripheral arterial disease, hypertension, diabetes mellitus and hypercholesterolemia. Intervention included statin, aspirin and surveillance. The primary outcome was all-cause mortality. Results 31,268 participants were randomized; 25,322 men in the control arm and 5,946 in the invited arm, of whom 3,720 attended and were screened (62·6%). In intention-to-treat analyses, after a median follow-up of 7·0 years, 555 (9.3%) men in the intervention group and 2,509 (9·9%) men in the control group had died; hazard ratio (HR) = 0.94 (95% CI: 0·86;1·03), p=0·169. Major adverse cardiovascular events (MACE) were registered in 606 (10·2%) versus 2,682 (10·6%) (HR=0·96 [95% CI 0·88;1.04]; p=0·319). Severe bleedings were significantly more common in the invited-to-screening group (6·0% versus 5·1%; HR=1·18 [95% CI 1·05;1·32]; p=0·007). This included intracranial (HR=1·23 (95% CI 0·96;1·58); p=0·097) and gastrointestinal bleedings (HR=1·18; (95% CI 1·03;1·34) p=0·014), respectively. Conclusions Invitation to a comprehensive CT-based screening for subclinical CVD did not decrease death over 7 years among men aged 60–64 years but did increase severe bleeding. Because the trial was powered for events over 10 years, further follow-up is needed. Clinicaltrials.gov number: NCT03946410