Optimising Lipid-Lowering Therapy for Acute Coronary Syndrome using a Decision Support System: Insights from a Cluster Randomised Trial

J. Brandts (Aachen)¹, C. Stevens (London)², J. Smith (London)³, M. Moreno Morales (London)³, B. Fotios (London)⁴, L. Janani (London)³, G. Kiru (London)³, N. Kaza (London)³, V. Cornelius (London)³, N. Poulter (London)⁵, K. Khunti (Leicester)⁶, J. McEvoy (Galway)⁷, A. Zambon (Padova)⁸, J. Lopez-Sendon (Madrid)⁹, D. Conolly (Birmingham)¹⁰, L. Hazell (London)³, K. Ray (London)^11
1Uniklinik RWTH Aachen Med. Klinik I - Kardiologie, Angiologie und Internistische Intensivmedizin Aachen, Deutschland; ²Imperial College London Department of Primary Care and Public Health, School of Public Health, London, Großbritannien; ³Imperial College London Imperial Clinical Trials Unit, School of Public Health London, Großbritannien; ⁴Imperial College London Department of Primary Care and Public Health, School of Public Health, London, Großbritannien; ⁵Imperial College London National Heart & Lung Institute London, Großbritannien; ⁶University of Leicester Diabetes Research Centre Leicester, Großbritannien; ⁷University of Galway National Institute for Preventive Cardiology Galway, Irland; ⁸University of Padova Department of Medicine I Padova, Italien; ⁹Hospital La Paz Institute for Health Research (IdiPAZ) Madrid, Spanien; ¹⁰The Midland Metropolitan University Hospital Department of Cardiology Birmingham, Großbritannien; ¹¹Imperial College London Public Health and Primary Care London, Großbritannien

Background:
Despite guideline emphasis on rapid LDL-C lowering after acute coronary syndrome (ACS), lipid-lowering therapy (LLT) in routine care frequently follows a sequential, stepwise approach, delaying initiation of combination therapy and achievement of LDL-C targets. Digital decision support systems (DSS) have the potential to facilitate treatment intensification by integrating patient data and individualised benefit estimates into clinical decision-making. We evaluated whether the availability of a DSS could modify LLT prescribing patterns compared with standard-of-care (SoC).
Methods:
This pragmatic, multinational, cluster-randomised controlled trial enrolled patients hospitalised for ACS at 42 sites in the United Kingdom, Italy, and Spain. Hospitals were randomised 1:1 to mandatory DSS use (providing estimates of recurrent cardiovascular event risk and expected benefit from different LLT scenarios, while leaving treatment decisions to the physician) or to SoC. The primary endpoint was the proportion of patients receiving intensified monotherapy or initiated/escalated combination LLT by week 16 compared to pre-admission LLT; secondary endpoints included individual components of the primary endpoint, proportions at goal (LDL-C<1.4mmol/L), and timing of LLT escalations.
Results:
A total of 1139 participants, 79% male, median age 62 years (IQR: 55, 69), 84% without prior CVD, 69% LLT-naïve at admission, median admission LDL-C 3.0 mmol/L (IQR: 2.46, 3.75) were enrolled. The primary endpoint was met in 71.7% (DSS) vs 65.7% (SoC), risk ratio (RR) 1.11 (95%CI:0.92-1.33, p=0.29). Intensification of monotherapy occurred in 9.0% vs 13.1% (RR:0.68, 95%CI:0.46-1.00), combination LLT in 61.6% vs 50.6% (RR:1.35, 95%CI:0.93-1.98). LDL-C goal achievement was 54.8% vs 50.3% (RR 1.06, 95%CI: 0.88-1.28), with LLT escalation before discharge in 64.8% vs 60.7%.
Conclusions:
Mandatory DSS access did not significantly improve LLT intensification or LDL-C goal attainment at 16 weeks post-ACS. However, trends toward earlier and more frequent combination LLT suggest that DSS-assisted care may promote more guideline-concordant prescribing, warranting confirmation in larger and longer-term studies.