6/28/23, 11:01 PM LODESTAR Pathway Feedback Search Clinical Topics Home Studies LODESTAR LODESTAR Disease Disease Coronary artery disease Dyslipidemia Trial question Is a treat-to-target strategy noninferior to a strategy of high-intensity statins in patients with coronary artery disease? Study design Multi-center Open label RCT Population Characteristics of study participants 28.0% female N = 4400 72.0% male 4400 patients (1228 female, 3172 male) Inclusion criteria: patients with a coronary artery disease diagnosis Key exclusion criteria: pregnancy; allergy to statins; life expectancy < 3 years; risk factors for myopathy with hereditary muscle disorder; hypothyroidism; AUD; severe hepatic dysfunction Interventions N=2200 treat-to-target strategy (titrated-intensity statin therapy with LDL cholesterol level between 50-70 mg/dL as the target) N=2200 high-intensity statin strategy (rosuvastatin 20 mg or atorvastatin 40 mg once daily) Primary outcome https://web.pathway.md/studies/recPLaijCHCasKK52 1/2 6/28/23, 11:01 PM LODESTAR Pathway Composite of death, myocardial infarction, stroke, or coronary revascularization at 3 years 8.7 % 8.7 8.1 6.5 % 4.3 % Difference not exceeding nonferiority margin 2.2 % 0.0 % Treat-to-target strategy High-intensity statin strategy Difference not exceeding nonferiority margin in composite of death, myocardial infarction, stroke, or coronary revascularization at 3 years (8.1% vs. 8.7%; ARD -0.6, 95% CI -0.96 to -0.24) Secondary outcomes No significant difference in new-onset diabetes (5.6% vs. 7%; ARD -1.3, 95% CI -2.8 to 0.1) No significant difference in discontinuation of statin therapy (1.5% vs. 2.2%; ARD -0.7, 95% CI -1.5 to 0.1) Significant decrease in composite of new-onset diabetes, aminotransferase or CK elevation, or end-stage kidney disease (6.1% vs. 8.2%; ARD -2.1, 95% CI -3.6 to -0.5) Conclusion In patients with a coronary artery disease diagnosis, treat-to-target strategy was noninferior to high- intensity statin strategy with respect to the composite of death, myocardial infarction, stroke, or coronary revascularization at 3 years. Reference Sung-Jin Hong, Yong-Joon Lee, Seung-Jun Lee et al. Treat-to-Target or High-Intensity Statin in Patients With Coronary Artery Disease: A Randomized Clinical Trial. JAMA. 2023 Mar 6;e232487. Open reference URL https://web.pathway.md/studies/recPLaijCHCasKK52 2/2