Coronary Heart Disease (CHD) remains a major cause of morbidity and mortality worldwide. The aim is to describe the rationale, study design, and first results of the Dutch Risk Or Benefit IN Screening for CArdiovascular disease (ROBINSCA) trial, the first population-based randomised-controlled Computed-Tomography screening trial for cardiovascular disease, powered to detect a benefit of 15% reduced CHD-morbidity and mortality.
Addresses of men (aged 45-74 years) and women (aged 55-74 years) were obtained (n=394,058) from the population registry. All received a mailing with an information brochure, a questionnaire and waist measurement tape and an informed consent form. Asymptomatic people with an expected high-risk for developing CHD were randomised (1:1:1) to one of the study arms: intervention arm A (screening by traditional risk factors), intervention arm B (screening by Coronary Artery Calcium scoring only) or the control arm (usual care).
A total of 87,866 (22.3%) people responded to the questionnaire, of which 43,447 (49.4%) were randomised to intervention arm A (n=14,478 (33.3%)), intervention arm B (n=14,450 (33.3%)), or the control arm (n=14,519 (33.4%)). Screening was completed in August 2018. In intervention arm A, 12,184 (84.2%) were screened and in 54.9% risk reducing treatment by the general practitioner was advised. In intervention arm B, 12,950 (89.6%) were screened and only 24% were advised to receive risk reducing treatment.
CHD-related morbidity and mortality will be measured at 5-year of follow-up. Evidence for net-effectiveness of population-based screening for cardiovascular risk in an asymptomatic population will possibly enable large health gains.