LODESTAR
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
72.0% male
N = 4400
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; alcohol use disorder; severe hepatic dysfunction.
Interventions
N=2200 treat-to-target strategy (titrated-intensity statin therapy with LDL-C 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
Composite of death, MI, stroke, or coronary revascularization at 3 years
8.1%
8.7%
8.7 %
6.5 %
4.3 %
2.2 %
0.0 %
Treat-to-target
strategy
High-intensity statin
strategy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in death, MI, 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 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, MI, 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 Apr 4;329(13):1078-1087.
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