Aims Screening for a high cardiovascular disease (CVD) risk followed by preventive treatment can potentially reduce coronary heart disease-related morbidity and mortality. ROBINSCA (Risk Or Benefit IN Screening for CArdiovascular disease) is a population-based randomized controlled screening trial that investigates the effectiveness of CVD screening in asymptomatic participants using the Systematic COronary Risk Evaluation (SCORE) model or coronary artery calcium (CAC) scoring. This study describes the distributions in risk and treatment in the ROBINSCA trial. Methods and results Individuals at expected elevated CVD risk were randomized into screening arm A (n = 14 478; SCORE, 10-year fatal and non-fatal risk); or screening arm B (n = 14 450; CAC scoring). Preventive treatment was largely advised according to current Dutch guidelines. Risk and treatment differences between the screening arms were analysed. A total of 12 185 participants (84.2%) in arm A and 12 950 (89.6%) in arm B were screened. In total, 48.7% were women, and median age was 62 (interquartile range 10) years. SCORE screening identified 45.1% at low risk (SCORE < 10%), 26.5% at intermediate risk (SCORE 10–20%), and 28.4% at high risk (SCORE ≥ 20%). According to CAC screening, 76.0% were at low risk (Agatston < 100), 15.1% at high risk (Agatston 100–399), and 8.9% at very high risk (Agatston ≥ 400). CAC scoring significantly reduced the number of individuals indicated for preventive treatment compared to SCORE (relative reduction women: 37.2%; men: 28.8%). Conclusion We showed that compared to risk stratification based on SCORE, CAC scoring classified significantly fewer men and women at increased risk, and less preventive treatment was indicated. Trial registration number NTR6471.
Introduction A teachable moment for preventive behavioural change can occur when asymptomatic individuals receive their cardiovascular disease screening result. This study investigated prevention-seeking behaviour and compliance with preventive treatment of participants of the population-based Risk Or Benefit IN Screening for CArdiovascular disease (ROBINSCA) trial after receiving a screening result. Methods Asymptomatic Dutch individuals ( n = 43,447) were randomly assigned (1:1:1) to screening for cardiovascular disease by either traditional risk assessment (intervention arm A), or determining the amount of coronary artery calcification (intervention arm B), or to usual care (control arm). A random sample ( n = 600) of ROBINSCA participants with a screening result (arms A and B) received an online questionnaire (in 2017) to measure the impact of a cardiovascular disease screening result in low and increased (arm A: risk > 10%; arm B: Agatston ≥ 100) risk groups. Results Of all respondents (438/600; 73%) 63.5% were men and the mean age ( ± standard deviation) was 63.8 ± 6.9 years. Individuals with an increased coronary artery calcification score consulted their general practitioner more often compared to increased risk individuals from arm A: 140/149 (94%) and 86/137 (62.8%), respectively ( P < 0.001). Current use of blood pressure and cholesterol-lowering drugs was significantly higher in the increased coronary artery calcification score group (108/140; 77.1%), compared to the group with an increased traditional risk (35/80, 43.8%; P < 0.001). Self-reported compliance was high (98.1–100%). Conclusion Receiving the screening result might be a teachable moment that can enhance cardiovascular disease prevention-seeking behaviour through consulting a general practitioner and high compliance with preventive treatment. The impact of the screening result was more profound in the increased coronary artery calcification score group. Trial registration number: NTR6471
The first two authors contributed equally. Trial registration number: NTR6471.
Introduction The ROBINSCA (Risk Or Benefit IN Screening for CArdiovascular disease) trial is a large-scale population-based randomized controlled screening trial with the aim to investigate whether screening for a high risk of cardiovascular disease (CVD) by means of either the Systematic COronary Risk Evaluation (SCORE) model or coronary artery calcium (CAC) scoring followed by preventive treatment is effective in reducing morbidity and mortality from coronary heart disease (CHD). This study shows the results of the CVD risks as assessed by the two screening tools. Methods Based on the Dutch population registry, 394,058 men aged 45–74 years and women aged 55–74 years received an information brochure, an invitation to participate in the trial, a baseline questionnaire with waist circumference tape and an informed consent form. Eligible individuals with an expected high CVD risk were randomized (1:1:1) into a control arm (n=14,519), intervention arm A (n=14,478) or intervention arm B (n=14,450). In the control arm, usual care was continued. In intervention arm A, participants were screened for a high risk of CVD using the SCORE model based on traditional risk factors. In intervention arm B, CAC scoring after computed tomography scanning was used for screening. After screening en risk communication, preventive treatment according to the Dutch guidelines is advised for high risk persons. Results Screening uptake was 84.2% in intervention arm A and 89.6% in intervention arm B. Of the screened participants, 48.7% was female, median age at screening was 62 (Interquartile Range 10), 35.2% was high educated, 19.6% was baseline smoker and 41.4% had a positive family history of myocardial infarction. The assessed CVD risk status according to SCORE screening was stratified into three risk categories; 45.1% was at low risk (SCORE<10%), 26.5% was at intermediate risk (SCORE 10–20%), and 28.4% was at high risk (SCORE ≥20%). According to CAC screening, 76.0% was at low risk (Agatston <100), 15.1% was at high risk (Agatston 100–399), and 8.9% was at very high risk (Agatston ≥400). Associations between baseline variables and increased CVD risk will be analyzed soon and will be available in summer 2019. Conclusions Using different screening tools resulted in reclassification of the CVD risk. CAC screening caused a substantial shift to more low risk individuals. This might, when screening is found to be effective, lead to less overtreatment in prevention of CVD events. Future 5-year follow-up data should provide evidence about whether population-based screening with subsequent preventive treatment is (cost-)effective in reducing CHD-related morbidity and mortality.
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