Comparison of Two Lipid Management Strategies in Very High Risk Patients

Study Overview
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Brief Summary
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Guideline recommended evidence-based clinical care correlates with improved patient outcomes. In real life care, however, adherence to guideline recommendations remains suboptimal. In real life, patients may receive suboptimal treatment and as a result treatment targets are not always met. To support and improve secondary prevention for cardiovascular disease, PENELOPE and PENELOPE-CTRL are designed to support guideline implementation on lipid management and provide valuable feedback to care-givers on real world data.

Detailed Description
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The recent PENELOPE study was designed to determine the effect of a protocolized, Dutch-, and ESC- guideline based strategy of stepwise intensified lipid management in patients at very high risk for ACS. In PENELOPE 22 Dutch non-academic hospitals, members of the WCN investigator network, implemented a protocol guided guideline approach in a consecutive cohort of very high-risk patients admitted for ACS over the period 01-01-2019 to 31-08-2020. Lipid values and medication strategy are collected at baseline (index ACS), and after three months and one year post ACS, in order to establish the percentage of patients on target (LDL). The current PENELOPE-CTRL study on the other hand, is designed to serve as a contemporary control cohort for PENELOPE. PENELOPE-CTRL is a retrospective observational study, creating a contemporary snapshot of real-life lipid management for secondary prevention in very high-risk patients. PENELOPE-CTRL will collect data in similar hospitals who did not participate in the PENELOPE trial. To allow comparison of these two strategies, protocol guided versus real life implementation of the cholesterol treatment guidelines, both cohorts include similar patients, and similar data will be collected (e.g., lipid lowering drugs, lipid panels) . Analysis will be done at similar time points. Comparing the real-life data from PENELOPE-CTRL with the data from the PENELOPE study will quantify the effect of a strategy of protocolized guideline-based lipid management with regards to the incidence of target LDL-C levels in very high-risk patients, 3 months and one year after hospitalisation with a myocardial infarction.

Official Title
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PENELOPE-CTRL: Real Life Lipid Management Compared to Protocolized Implementation of the Current Dutch- and ESC-guidelines in Very High-risk CV-patients

Conditions
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Atherosclerotic Cardiovascular Disease, STEMI, Non STEMI

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 and ≤70 years Alive at hospital discharge after admission for (N)STEMI between 1-1-2019 and 31-08-2020 Planned for follow-up at a participating PENELOPE CTRL site History of T2DM and/or history of ASCVD defined as either one of: cerebrovascular disease/ event: transient ischemic attack, cerebral infarction, amaurosis fugax, retinal infarction Coronary artery disease/ event: unstable angina pectoris, MI, ACS, coronary revascularization (coronary angioplasty or surgical procedure for coronary bypass) Peripheral artery disease (symptomatic and documented obstruction of a distal extremity artery or surgical intervention (percutaneous transluminal angioplasty, bypass or amputation) Exclusion Criteria: Pregnant and lactating women Participation in lipid modifying drug trials up to two years after index cardiovascular event

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients reaching the LDL-C target level (≤ 1.8 mmol/L) | reaching LDL-C target level (≤ 1.8 mmol/L) 3 months after admission for a type I (N)STEMI, compared to the designated PENELOPE cohort | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of LDL-C target level (≤ 1.8 mmol/L) | Incidence of LDL-C (≤ 1.8 mmol/L) at baseline (admission for a type I (N)STEMI), 3 months and 1 year after baseline, compared to the designated PENELOPE cohort. | 1 year | 
| Incidence of LDL-C target level (≤ 1.4 mmol/L) | Incidence of LDL-C (≤ 1.4 mmol/L) at baseline (admission for a type I (N)STEMI), 3 months and 1 year after baseline, compared to the designated PENELOPE cohort. | 1 year | 
| incidence of achieving 50% LDL-C reduction | Incidence of achieving 50% LDL-C reduction compared to baseline, after 3 months and 1 year, also adjusted to the start date of the related drug regimen. | 1 year | 
| LLT compared to PENELOPE cohort | Lipid lowering therapy at baseline, after 3 months and 1 year, compared to the designated PENELOPE cohort. | 1 year | 
| LDL-C level 3 months after adjustment | LDL-C level at 3 months, also adjusted to the start date of the related drug regimen. | 3 months |