Optimising lipid-lowering therapy for acute coronary syndrome using a decision support system: insights from a cluster randomised trial
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Accepted version
Supporting information
Author(s)
Type
Journal Article
Abstract
AIMS: Lipid-lowering therapy (LLT) after acute coronary syndrome (ACS) typically follows stepwise intensification, delaying use of combination therapies and 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: Pragmatic, multinational, parallel 1:1 cluster-randomised 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<1.4mmol/L), and timing of LLT
escalations.
RESULTS: 42 sites from UK, Italy and Spain were randomised, enrolling 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). 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: 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.
METHODS: Pragmatic, multinational, parallel 1:1 cluster-randomised 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<1.4mmol/L), and timing of LLT
escalations.
RESULTS: 42 sites from UK, Italy and Spain were randomised, enrolling 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). 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: 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.
Date Acceptance
2025-11-10
Citation
European Heart Journal: Digital Health
ISSN
2634-3916
Publisher
Oxford University Press
Journal / Book Title
European Heart Journal: Digital Health
Copyright Statement
Copyright This paper is embargoed until publication. Once published the Version of Record (VoR) will be available on immediate open access.
License URL
Publication Status
Accepted