Treat-to-Target or High-Intensity Statin in Patients With Coronary Artery Disease A Randomized Clinical Trialopen access
- Authors
- Hong, Sung-Jin; Lee, Yong-Joon; Lee, Seung-Jun; Hong, Bum-Kee; Kang, Woong Chol; Lee, Jong-Young; Lee, Jin-Bae; Yang, Tae-Hyun; Yoon, Junghan; Ahn, Chul-Min; Kim, Jung-Sun; Kim, Byeong-Keuk; Ko, Young-Guk; Choi, Donghoon; Jang, Yangsoo; Hong, Myeong-Ki
- Issue Date
- Apr-2023
- Publisher
- AMER MEDICAL ASSOC
- Citation
- JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, v.329, no.13, pp.1078 - 1087
- Journal Title
- JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
- Volume
- 329
- Number
- 13
- Start Page
- 1078
- End Page
- 1087
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/88045
- DOI
- 10.1001/jama.2023.2487
- ISSN
- 0098-7484
- Abstract
- 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.
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