Treat-to-Target or High-Intensity Statin in Patients With Coronary Artery Disease: A Randomized Clinical Trial
Sung-Jin Hong1, Yong-Joon Lee1, Seung-Jun Lee1
1Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Insights
A treat-to-target low-density lipoprotein cholesterol (LDL-C) strategy was noninferior to high-intensity statin therapy in patients with coronary artery disease. This approach ensures comparable clinical outcomes while allowing for personalized statin dosing.
Area of Science:
- Cardiovascular Medicine
- Clinical Trials
- Pharmacology
Background:
- Current guidelines offer varying statin intensity recommendations for coronary artery disease (CAD).
- Head-to-head comparisons of treat-to-target versus high-intensity statin strategies are limited in CAD patients.
Purpose of the Study:
- To evaluate if a treat-to-target strategy is noninferior to high-intensity statins for long-term clinical outcomes in CAD.
- To compare the efficacy and safety of individualized LDL-C goals versus maximal statin intensity.
Main Methods:
- A randomized, multicenter, noninferiority trial involving patients with diagnosed coronary artery disease.
- Patients were assigned to either an LDL-C target of 50-70 mg/dL or high-intensity statin therapy (rosuvastatin 20mg or atorvastatin 40mg).
- The primary endpoint was a 3-year composite of death, myocardial infarction, stroke, or coronary revascularization.
Main Results:
- The treat-to-target strategy (mean LDL-C: 69.1 mg/dL) was noninferior to high-intensity statin therapy (mean LDL-C: 68.4 mg/dL).
- The primary endpoint occurred in 8.1% of the treat-to-target group vs. 8.7% of the high-intensity group (P < .001 for noninferiority).
- This indicates comparable effectiveness in preventing major adverse cardiovascular events over 3 years.
Conclusions:
- A treat-to-target LDL-C strategy is a suitable alternative to high-intensity statin therapy in CAD patients.
- This approach allows for personalized treatment, accommodating individual responses to statins.
- Findings support tailored statin therapy for managing coronary artery disease.
Importance:
In patients with coronary artery disease, some guidelines recommend initial statin treatment with high-intensity statins to achieve at least a 50% reduction in low-density lipoprotein cholesterol (LDL-C). An alternative approach is to begin with moderate-intensity statins and titrate to a specific LDL-C goal. These alternatives have not been compared head-to-head in a clinical trial involving patients with known coronary artery disease.
Objective:
To assess whether a treat-to-target strategy is noninferior to a strategy of high-intensity statins for long-term clinical outcomes in patients with coronary artery disease.
Design, Setting, And Participants:
A randomized, multicenter, noninferiority trial in patients with a coronary disease diagnosis treated at 12 centers in South Korea (enrollment: September 9, 2016, through November 27, 2019; final follow-up: October 26, 2022).
Interventions:
Patients were randomly assigned to receive either the LDL-C target strategy, with an LDL-C level between 50 and 70 mg/dL as the target, or high-intensity statin treatment, which consisted of rosuvastatin, 20 mg, or atorvastatin, 40 mg.
Main Outcomes And Measures:
Primary end point was a 3-year composite of death, myocardial infarction, stroke, or coronary revascularization with a noninferiority margin of 3.0 percentage points.
Results:
Among 4400 patients, 4341 patients (98.7%) completed the trial (mean [SD] age, 65.1 [9.9] years; 1228 females [27.9%]). In the treat-to-target group (n = 2200), which had 6449 person-years of follow-up, moderate-intensity and high-intensity dosing were used in 43% and 54%, respectively. The mean (SD) LDL-C level for 3 years was 69.1 (17.8) mg/dL in the treat-to-target group and 68.4 (20.1) mg/dL in the high-intensity statin group (n = 2200) (P = .21, compared with the treat-to-target group). The primary end point occurred in 177 patients (8.1%) in the treat-to-target group and 190 patients (8.7%) in the high-intensity statin group (absolute difference, -0.6 percentage points [upper boundary of the 1-sided 97.5% CI, 1.1 percentage points]; P < .001 for noninferiority).
Conclusions And Relevance:
Among patients with coronary artery disease, a treat-to-target LDL-C strategy of 50 to 70 mg/dL as the goal was noninferior to a high-intensity statin therapy for the 3-year composite of death, myocardial infarction, stroke, or coronary revascularization. These findings provide additional evidence supporting the suitability of a treat-to-target strategy that may allow a tailored approach with consideration for individual variability in drug response to statin therapy.
Trial Registration:
ClinicalTrials.gov Identifier: NCT02579499.
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