The Pragmatic EE-PRS Trial assessing Polygenic Risk Driven Statin Therapy for Cardiovascular Disease Prevention

High polygenic risk for coronary artery disease

Time to the first occurrence of Major Adverse Cardiovascular Events (MACE), ICD-10 codes: ischaemic heart disease (I20–I25), stroke or transient ischemia (I60–64, I69, G45), peripheral vascular occlusion (I65–66, I67.2, I70, I73.9), revascularization (Z95.1, Z95.5, Z95.8, Z95.9) or cardiovascular death (I00-78) from baseline.

- Incidence rate of death from any cause among the study participants., - Change in CVD risk factors from baseline (LDL-cholesterol, blood pressure, BMI, waist circumference, smoking, alcohol consumption prevalence) by the end of the trial in the intervention and control arm., - Treatment adherence in the intervention arm based on prescriptions and purchases of statins (C10AA, C10BA) and self-reporting using the MARS-5 scale., - Fidelity of implementation assessed by participant feedback, and adherence to program activities (record analysis)., - Acceptability of the primary prevention program across study participants., - Satisfaction with study processes and results., Difference in plasma concentrations of rosuvastatin comparing study participants with and without a mutation in the SLCO1B1, ABCG2, CYP2C9, CYP2C19, UGT-d, SLCO1B3, SLCO2B1, ABCC2, ABCB11 genes., Difference in rosuvastatin side effects between study participants with and without a mutation in the SLCO1B1, ABCG2, CYP2C9, CYP2C19, UGT-d, SLCO1B3, SLCO2B1, ABCC2, ABCB11 genes., Difference in side effects and overall trial outcomes depending on gut microbiome composition and functionality., Utilisation of healthcare resources (non-trial physician and cardiologist visits, hospitalizations, length of stay, health care and informal resource use, direct healthcare costs.), - Number of participants with adverse events and serious adverse events from statin therapy., - Number of participants who withdrew or dropped out from the study., - Utilities from the EQ-5L-5D surveys and productivity costs from the iPCQ survey for calculating quality-adjusted life years (QALY) gained over a lifetime, incremental cost-effectiveness ratio (ICER).

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