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

Limited data suggest a benefit of population-based screening for cardiovascular disease (CVD) with respect to mortality.

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 hypercholesterolaemia. Intervention included statin, aspirin, and surveillance. The primary outcome was all-cause mortality.

A total of 31 268 participants were randomized, 25 322 men in the control arm and 5946 in the invited arm, of whom 3720 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 2509 (9.9%) men in the control group had died; {hazard ratio [HR] = .94 [95% confidence interval (CI)]: .86; 1.03}; P = .169. Major adverse cardiovascular events were registered in 606 (10.2%) vs 2682 (10.6%) [HR = .96 (95% CI: .88; 1.04); P = .319]. Severe bleedings were significantly more common in the invited-to-screening group [6.0% vs 5.1%; HR = 1.18 (95% CI: 1.05; 1.32); P = .007]. In a simulated per-protocol analysis, attending screening reduced mortality by 17% (95% CI: 25; 29%)

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.