Carlijn M van der Aalst1, Sabine J A M Denissen1, Marleen Vonder2, Jan Willem C Gratama3, Henk J Adriaansen4, Dirkjan Kuijpers5,6, Rozemarijn Vliegenthart2, Jeanine E Roeters van Lennep7, Pim van der Harst2,8,9, Richard L Braam10, Paul R M van Dijkman11,12, Rykel van Bruggen13, Matthijs Oudkerk14,15, Harry J de Koning1. 1. Department of Public Health, Erasmus Medical Centre, PO Box 2040, 3000 CA Rotterdam, The Netherlands. 2. Centre for Medical Imaging North-East Netherlands (CMI-NEN), University Medical Centre Groningen, Hanzeplein 1, EB45, Groningen 9713 GZ, The Netherlands. 3. Department of Radiology and Nuclear Medicine, Gelre Hospitals, Albert Schweitzerlaan 31, 7334 DZ Apeldoorn, The Netherlands. 4. Department of Clinical Chemistry and Hematology Laboratory, Gelre Hospitals, Albert Schweitzerlaan 31, 7334 DZ Apeldoorn, The Netherlands. 5. Department of Radiology, University Medical Centre Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands. 6. Department of Radiology, Haaglanden Medical Centre Bronovo, Bronovolaan 5, 2597 AX Den Haag, The Netherlands. 7. Department of Internal Medicine, Erasmus Medical Centre, Doctor Molewaterplein 40, 3015 GD Rotterdam, The Netherlands. 8. Department of Cardiology, University Medical Centre Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands. 9. Department of Cardiology, University Medical Centre Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands. 10. Department of Cardiology, Gelre Hospitals, Albert Schweitzerlaan 31, 7334 DZ Apeldoorn, The Netherlands. 11. Department of Cardiology, Leids University Medical Centre, Albinusdreef 2, 2333 ZA Leiden, The Netherlands. 12. Department of Cardiology, Haaglanden Medical Centre Bronovo, Bronovolaan 5, 2597 AX Den Haag, The Netherlands. 13. General practice, Arnhemseweg 2 A, 7331 BK Apeldoorn, The Netherlands. 14. University of Groningen, University Medical Centre Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands. 15. Institute for Diagnostic Accuracy-iDNA, Prof. E.D. Wiersmastraat 5, 9713 GH Groningen, The Netherlands.
Abstract
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. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
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. Published on behalf of the European Society of Cardiology. All rights reserved.
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