Key Points
- Maximizing lipid lowering therapy (LLTs) to optimize residual cardiovascular disease (CVD) risk after acute coronary syndrome (ACS) is usually a stepwise approach that can take months or years for many patients.
- This randomized control trial tested whether a decision support system (DSS) that provided information about residual CVD risk after ACS as well as the potential benefits of various LLTs would lead to earlier optimization compared to standard of care (SoC) pathways.
- The DDS did not significantly improve intensity of LLT treatment of percentage of patients receiving LDL-C goals within the study timeframe – however the favorable trends observed implies that this system may have value in other settings where the current SOC performance is lower than in the trial.
More than 75% of patients with ACS are naïve to LLT on presentation, and only 25% are able to achieve guidelines LDL-C goals within 3 months post-ACS when a single LLT agent is used. Most patients require combination therapy to get to goal, and getting to goal early and sustaining this improvement over time is associated with improved cardiovascular outcomes. Whether a DSS can shorten the time to combination therapy and reduce the delay to getting to goal compared to usual care is uncertain.
On November 17th 2024, the results of “OptimiZation Of Lipid Lowering Therapies Using A Decision Support System In Patients With Acute Coronary Syndrome (ZODIAC): A Randomized Controlled Trial” were presented at AHA Scientific Sessions 2024. The purpose of this study was to determine if a DSS providing estimates of residual CVD risk and the benefits of various LLTs based on the 2019 European Society Guidelines would lead to earlier optimization of lipid therapy and lipid levels compared to SoC.
This interventional, parallel-assignment, statistician-blinded, cluster-randomized controlled trial included 1140 adults from 42 sites in the UK, Italy, and Spain who were less than 80 years old and hospitalized for less than 72 hours post-ACS. They were assigned in a 1:1 fashion at each site to the DSS or SOC. The primary endpoint was the proportion of patients who received combination therapy, escalated monotherapy, or escalated combination therapy within 16 weeks of ACS.
The median age was 62 years, 22% were female, and the mean LDL-C was 116 mg/dL; 67% were LLT naïve on presentation. Overall, 59.7% of patients in the SoC arm and 70.7% of patients in the DSS arm achieved the primary endpoint, a difference that did not reach statistical significance (RR 1.15 [95% CI 0.93-1.41]). There was also no significant difference in the primary endpoint among any of the prespecified subgroups, including a prior history of ASCD or LLT exposure. There was an overall shift in prescribing behavior towards more potent combination therapies in the DSS arm, and more participants received their first LLT escalation prior to discharge in the DSS arm.
One limitation of this study was power to detect clinically significant differences. Additionally, awareness of ZODIAC aims may have biased clinician decisions in the control arm, as the SOC pathways outperformed historical data the authors used for their power calculation.
Kausik K. Ray MD, FAHA, FMedSci, Professor of Public Health, Imperial College of London, concluded: “Availability of a DSS system did not significantly improve use of combination therapies and intensification of LLT regimens versus current care pathways. Favorable trends were seen in the DSS arm and this may have value in other settings where the implementation is slower such as primary care – this requires further evaluation.”