User-defined outcomes of the Danish cardiovascular screening (DANCAVAS) trial: A post hoc analyses of a population-based, randomised controlled trial.

Background: The Danish cardiovascular screening (DANCAVAS) trial, a nationwide trial designed to investigate the impact of cardiovascular screening in men, did not decrease all-cause mortality, an outcome decided by the investigators. However, the target group may have varied preferences. In this study, we aimed to evaluate whether men aged 65 to 74 years requested a CT-based cardiovascular screening examination and to assess its impact on outcomes determined by their preferences. Methods and findings: This is a post hoc study of the randomised DANCAVAS trial. All men 65 to 74 years of age residing in specific areas of Denmark were randomised (1:2) to invitation-to-screening (16,736 men, of which 10,471 underwent screening) or usual-care (29,790 men). The examination included among others a non-contrast CT scan (to assess the coronary artery calcium score and aortic aneurysms). Positive findings prompted preventive treatment with atorvastatin, aspirin, and surveillance/surgical evaluation. The usual-care group remained unaware of the trial and the assignments. The user-defined outcome was based on patient preferences and determined through a survey sent in January 2023 to a random sample of 9,095 men from the target group, with a 68.0% response rate (6,182 respondents). Safety outcomes included severe bleeding and mortality within 30 days after cardiovascular surgery. Analyses were performed on an intention-to-screen basis. Prevention of stroke and myocardial infarction was the primary motivation for participating in the screening examination. After a median follow-up of 6.4 years, 1,800 of 16,736 men (10.8%) in the invited-to-screening group and 3,420 of 29,790 (11.5%) in the usual-care group experienced an event (hazard ratio (HR), 0.93 (95% confidence interval (CI), 0.88 to 0.98; p = 0.010); number needed to invite at 6 years, 148 (95% CI, 80 to 986)). A total of 324 men (1.9%) in the invited-to-screening group and 491 (1.7%) in the usual-care group had an intracranial bleeding (HR, 1.17; 95% CI, 1.02 to 1.35; p = 0.029). Additionally, 994 (5.9%) in the invited-to-screening group and 1,722 (5.8%) in the usual-care group experienced severe gastrointestinal bleeding (HR, 1.02; 95% CI, 0.95 to 1.11; p = 0.583). No differences were found in mortality after cardiovascular surgery. The primary limitation of the study is that exclusive enrolment of men aged 65 to 74 renders the findings non-generalisable to women or men of other age groups. Conclusion: In this comprehensive population-based cardiovascular screening and intervention program, we observed a reduction in the user-defined outcome, stroke and myocardial infarction, but entail a small increased risk of intracranial bleeding. Trial registration: ISRCTN Registry number, ISRCTN12157806https://www.isrctn.com/ISRCTN12157806. In this post-hoc analysis of the DANCAVAS trial, Axel Diederichsen and colleagues explore how cardiovascular screening impacts on outcomes as defined by patients themselves. Author summary: Why was this study done?: Stroke and heart attack remain a prevalent cause of decreased quality of life and premature death. Coronary atherosclerosis serves as an important risk modifier and is easily identifiable by cardiac imaging. Despite this, screening for cardiovascular disease by cardiac CT in the Danish cardiovascular screening (DANCAVAS) trial did not lead to a decrease in death from cardiovascular causes. However, it is essential to recognise that patients may have preferences other than death, and these preferences play a critically important role in informed and shared decision-making between caregivers and patients. What did the researchers do and find?: The DANCAVAS trial included men aged 65 to 74 from specific areas of Denmark, with some receiving invitations to screening (16,736 men) and others receiving usual care (29,790 men). Patients with significant atherosclerosis were treated with atorvastatin, aspirin, and underwent surveillance or surgery in case of aneurysms. Here, the study outcomes were determined based on patient preferences, which were assessed through a survey of a random sample of 9,095 men aged 65 to 74. The surveyed men expressed a preference for preventing stroke and heart attack over death. Screening reduced the absolute risk of stroke and heart attack by 0.7%, but it also increased the risk of intracranial haemorrhage by 0.2%. What do these findings mean?: The DANCAVAS trial met patient preferences, but the benefits were modest and accompanied by a slight increase in the risk of intracranial haemorrhage. These data suggest that there is limited benefit to the widespread implementation of cardiovascular screening programmes. The trial specifically targeted men aged 65 to 74, meaning the findings cannot be generalised to women or men outside this age group. Future cardiovascular screening programs should encompass both sexes and accommodate patient preferences. Additionally, they might consider excluding aspirin from the intervention arm. [ABSTRACT FROM AUTHOR]