Evaluation after delayed and repeated intervention in the VIPVIZA-extended randomized controlled trial: beneficial results 6 years after baseline

Abstract Aims The Västerbotten Intervention Programme VIsualiZation of subclinical Atherosclerosis (VIPVIZA) pragmatic randomized controlled trial (RCT) previously reported reduced cardiovascular disease (CVD) risk 3 years after colour-coded information about subclinical atherosclerosis based on carotid ultrasonography and facilitated by nurse-led motivational dialogue. This report evaluated the development of CVD risk and clinical risk factors following the 3-year follow-up, at which point the control group received their first delayed intervention and the intervention group received a repeated VIPVIZA intervention. Methods and results Participants (n = 3532) were recruited during 2013–2016 and randomized into two groups. Routine primary care managed preventive treatments. At the 6-year follow-up, group differences in CVD risk factors, the European Systematic Coronary Risk Evaluation 2 (SCORE2), and Framingham Risk Score (FRS) were statistically tested. Trajectories of the outcomes in both groups were graphically assessed. The participation rate after 6 years was 75.4%. No significant differences were found between groups in levels of SCORE2, FRS, clinical risk factors, anthropometrics, smoking, or diabetes—except for systolic blood pressure, which was lower in the original intervention group. Risk scores and systolic blood pressure increased in both groups in parallel, while LDL levels decreased and converged. The higher the baseline risk was, the stronger the decrease of LDL cholesterol. Conclusion When the delayed VIPVIZA intervention was provided to the control group after 3 years, the beneficial effect appeared similar as previously reported for the intervention group. After 6 years, any differences between groups in CVD risk were no longer seen. Cholesterol levels were greatly reduced in both groups. Registration The VIPVIZA trial is registered with www.clinicaltrials.gov (NCT01849575).