The 3-year composite of death, myocardial infarction, coronary revascularization, and stroke outcomes were comparable between treat-to-target and high-intensity statins in coronary artery disease patients in a recent randomized trial.
Coronary artery disease (CAD) is associated with an increased risk for adverse cardiovascular events. Studies have recommended statin therapy for reducing the levels of low-density lipoprotein cholesterol (LDL-C) in at-risk patients, which has proportionately decreased the risk of adverse vascular events. While some guidelines suggest treatment initiation with high-intensity statins, an alternative approach is based on the administration of moderate-intensity statins, followed by dosage adjustment.
In this randomized trial, the authors aimed to compare the efficacy of a high-intensity statin approach with a treat-to-target strategy in CAD patients for different cardiovascular outcomes. The study findings are published in the Journal of the American Medical Association.
Baseline Characteristics
A total of 4400 CAD patients were included in the trial and were equally randomized to the high-intensity statin and treat-to-target treatment groups. The baseline characteristics were not significantly different across the two groups. The mean age of the participants was 65 ±10 years. The treat-to-target and high-intensity statin groups comprised 72% and 73% males, respectively. CAD was identified at the time of screening in approximately 19% and 18% of the treat-to-target and high-intensity participants, respectively.
Patient Follow-Up and Dose Adjustment
Of the total participants, 98.7% completed the follow-up period of 3 years. In the treat-to-target group, the moderate-intensity statins were uptitrated, downtitrated, and maintained in 17%, 9%, and 73% of the patients, respectively. The utilization of ezetimibe was relatively greater in the treat-to-target group compared to the high-intensity statin group over the period of 6 months.
Statin Treatment and Low-Density Lipoprotein Cholesterol Levels
The mean levels of LDL-C at 6 weeks were significantly greater in the treat-to-target group compared to the high-intensity statin group (69.6 ± 21.2 mg/dL vs. 66.8 ± 21.8; p < 0.001). However, the LDL-C levels were not significantly different across the two groups during the overall study period (p < 0.21). The proportion of CAD patients with LDL-C levels less than 70 mg/dL was significantly higher in the high-intensity statin group compared to the treat-to-target group at 6 weeks and 3 months.
Primary and Secondary Endpoints
The primary endpoint (death, myocardial infarction, coronary revascularization, or stroke) was significantly different between the treat-to-target and high-intensity statin groups (8.1% vs 8.7%; p < 0.001). The study components of the primary endpoint, including all-cause death, myocardial infarction, and stroke, were not significantly different between CAD patients in the treat-to-target and high-intensity statin groups. Among secondary endpoints, the incidence of new-onset diabetes and cataract surgery was not significantly different across the two groups. However, the composite of new-onset diabetes, end-stage kidney disease, or an increase in aminotransferase or creatine kinase levels was significantly lower in the treat-to-target group (p < 0.009).
Source:
Hong, S., Lee, Y., Lee, S., Hong, B., Kang, W. C., Lee, J., Lee, J., Yang, T., Yoon, J., Ahn, C., Kim, J., Kim, B., Ko, Y., Choi, D., Jang, Y., Hong, M., Hong, M., Choi, D., Ko, Y., . . . Kim, H. K. (2023). Treat-to-Target or High-Intensity statin in patients with coronary artery disease. JAMA, 329(13), 1078. https://doi.org/10.1001/jama.2023.2487
