Optimizing lipid-lowering therapy for acute coronary syndrome using a decision support system: insights from a cluster randomized trial
Stevens, Christophe A T Smith, Jessica Brandts, Julia Barkas, Fotios Morales, Maria Moreno Janani, Leila Kiru, Gaia Kaza, Nandita Cornelius, Victoria Poulter, Neil R
Stevens, Christophe A T
Smith, Jessica
Brandts, Julia
Barkas, Fotios
Morales, Maria Moreno
Janani, Leila
Kiru, Gaia
Kaza, Nandita
Cornelius, Victoria
Poulter, Neil R
Abstract
Aims: Lipid-lowering therapy (LLT) after acute coronary syndrome (ACS) typically follows stepwise intensification, delaying use of combination therapies and low-density lipoprotein cholesterol (LDL-C) goal attainment. We assessed whether access to a decision support system (DSS) altered the intensity of LLT prescribing vs. standard-of-care (SoC). Methods and results: Pragmatic, multinational, parallel 1:1 cluster-randomized controlled trial of ACS patients comparing mandatory access to a DSS (providing estimates of cardiovascular events and benefits from different LLT scenarios) to SoC. The primary endpoint was the proportion 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 < 1.4 mmol/L), and timing of LLT escalations. 42 sites from UK, Italy, and Spain were randomized, enrolling 1139 participants, 79% male, median age 62 years (IQR: 55, 69), 84% without prior CVD, 69% LLT-naïve at admission, and median admission LDL-C 3.0 mmol/L (IQR: 2.46, 3.75). The primary endpoint was met in 71.7% (DSS) vs. 65.7% (SoC) and 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%. Conclusion: Access to a DSS, in hospitals managing ACS, did not improve LLT intensification within 16 weeks or LDL-C goal attainment but revealed a favourable trend towards earlier combination LLT use, which merits larger, longer studies in other settings.
MIDER Authors
Affiliations
Sandwell and West Birmingham NHS Trust; Imperial College London; RWTH University Hospital Aachen; University of Ioannina; et a.
Date
2025-11-17
Type
Article
Collections
Citation
Stevens CAT, Smith J, Brandts J, Barkas F, Morales MM, Janani L, Kiru G, Kaza N, Cornelius V, Poulter NR, Khunti K, McEvoy JW, Zambon A, Lopez-Sendon JL, Connolly D, Hazell L, Ray KK; ZODIAC trial. Optimizing lipid-lowering therapy for acute coronary syndrome using a decision support system: insights from a cluster randomized trial. Eur Heart J Digit Health. 2025 Nov 17;7(2):ztaf135. doi: 10.1093/ehjdh/ztaf135. Erratum in: Eur Heart J Digit Health. 2026 May 19;7(5):ztag071. doi: 10.1093/ehjdh/ztag071