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Treat-to-Target or High-Intensity Statin in Patients With Coronary Artery Disease: A Randomized Clinical Trial

Authors
 Sung-Jin Hong  ;  Yong-Joon Lee  ;  Seung-Jun Lee  ;  Bum-Kee Hong  ;  Woong Chol Kang  ;  Jong-Young Lee  ;  Jin-Bae Lee  ;  Tae-Hyun Yang  ;  Junghan Yoon  ;  Chul-Min Ahn  ;  Jung-Sun Kim  ;  Byeong-Keuk Kim  ;  Young-Guk Ko  ;  Donghoon Choi  ;  Yangsoo Jang  ;  Myeong-Ki Hong 
Citation
 JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, Vol.329(13) : 1078-1087, 2023-04 
Journal Title
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
ISSN
 0098-7484 
Issue Date
2023-04
MeSH
Aged ; Atorvastatin* / administration & dosage ; Atorvastatin* / adverse effects ; Atorvastatin* / therapeutic use ; Cholesterol, LDL* / blood ; Coronary Artery Disease* / blood ; Coronary Artery Disease* / complications ; Coronary Artery Disease* / drug therapy ; Female ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors* / administration & dosage ; Hydroxymethylglutaryl-CoA Reductase Inhibitors* / adverse effects ; Hydroxymethylglutaryl-CoA Reductase Inhibitors* / therapeutic use ; Hyperlipoproteinemias* / blood ; Hyperlipoproteinemias* / complications ; Hyperlipoproteinemias* / drug therapy ; Male ; Middle Aged ; Myocardial Infarction / etiology ; Rosuvastatin Calcium* / administration & dosage ; Rosuvastatin Calcium* / adverse effects ; Rosuvastatin Calcium* / therapeutic use ; Stroke / etiology ; Treatment Outcome
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.
Full Text
https://jamanetwork.com/journals/jama/fullarticle/2802214
DOI
10.1001/jama.2023.2487
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Ko, Young Guk(고영국) ORCID logo https://orcid.org/0000-0001-7748-5788
Kim, Byeong Keuk(김병극) ORCID logo https://orcid.org/0000-0003-2493-066X
Kim, Jung Sun(김중선) ORCID logo https://orcid.org/0000-0003-2263-3274
Ahn, Chul-Min(안철민) ORCID logo https://orcid.org/0000-0002-7071-4370
Lee, Seung-Jun(이승준) ORCID logo https://orcid.org/0000-0002-9201-4818
Lee, Yong Joon(이용준)
Choi, Dong Hoon(최동훈) ORCID logo https://orcid.org/0000-0002-2009-9760
Hong, Myeong Ki(홍명기) ORCID logo https://orcid.org/0000-0002-2090-2031
Hong, Bum Kee(홍범기) ORCID logo https://orcid.org/0000-0002-6456-0184
Hong, Sung Jin(홍성진) ORCID logo https://orcid.org/0000-0003-4893-039X
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/194174
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