Impact of coronary computed tomography angiography image visualisation on low-density lipoprotein cholesterol reduction in non-obstructive coronary artery disease: a multicentre randomised trial

Background Non-obstructive coronary artery disease (NOCAD) is increasingly identified with the expanding use of coronary computed tomography angiography (CCTA). Although lipid-lowering therapy is recommended, lipid control remains suboptimal in clinical practice. Observational studies suggest that visualisation of coronary atherosclerosis may improve patient adherence and treatment intensification, but randomized evidence remains limited. Purpose To determine whether personal CCTA image visualisation combined with structured preventive consultation results in greater reduction in low-density lipoprotein cholesterol (LDL-C) at 12 months compared with structured preventive consultation without CCTA visualisation or usual care in statin-naïve patients with newly diagnosed NOCAD. Methods In this multicentre randomised controlled trial, symptomatic statin-naïve patients undergoing first-line CCTA and diagnosed with NOCAD were enrolled following statin initiation. Immediately after CCTA, all randomised patients received a standardised written summary of scan findings with recommendations on lifestyle, lipid-lowering therapy, LDL-C targets, and blood pressure goals. Participants were randomized 1:1:1 to: (1) usual care group with follow-up in general practice; (2) a low-intensity strategy consisting of a single 30-minute specialised nurse-led preventive consultation focused on cardiovascular risk assessment and lipid management; or (3) a 45-minute high-intensity strategy combining the consultation (2) with personal standard CCTA and AI-based atherosclerotic plaque quantification image visualisation. Further follow-up was at the general practitioner's discretion. The primary endpoint was change in LDL-C from baseline to 12 months (intention-to-treat). Results were compared with a matched historical cohort from the Western Denmark Heart Registry (n=660), comprising statin-naïve patients with NOCAD receiving no structured follow-up. Results Among 171 participants (mean age 63.2 ±9.6 years, 42% women), median baseline LDL-C was 3.10 mmol/L. At 12 months, LDL-C was reduced by 47% with no difference between randomised groups (Figure), and statin adherence was high across randomisation groups (88%). In contrast, the matched external cohort achieved a 25% LDL-C reduction over one year. Conclusions In statin-naïve patients with NOCAD, participation in a structured randomized trial was associated with substantial LDL-C reduction and high statin adherence over 12 months, regardless of preventive strategy. Personal CCTA image visualisation provided no additional benefit beyond consultation and standardised written information. LDL-C reductions in the trial – even in the usual care group – exceeded those in a matched real-world NOCAD cohort, suggesting that trial participation itself (Hawthorne effect) together with standardised written information accounted for much of the observed benefit.