Treat-to-Target or High-Intensity Statin in Patients With Coronary Artery Disease
Author:
Hong Sung-Jin1, Lee Yong-Joon1, Lee Seung-Jun1, Hong Bum-Kee2, Kang Woong Chol3, Lee Jong-Young4, Lee Jin-Bae5, Yang Tae-Hyun6, Yoon Junghan7, Ahn Chul-Min1, Kim Jung-Sun1, Kim Byeong-Keuk1, Ko Young-Guk1, Choi Donghoon1, Jang Yangsoo8, Hong Myeong-Ki1, Hong Myeong-Ki9, Choi Donghoon9, Ko Young-Guk9, Kim Byeong-Keuk9, Kim Jung-Sun9, Ahn Chul-Min9, Hong Sung-Jin9, Lee Seung-Jun9, Lee Yong-Joon9, Hong Bum-Kee9, Kwon Hyuck Moon9, Kim Jong-Youn9, Min Pil Ki9, Yoon Young Won9, Lee Byoung Kwon9, Rim Se-Joong9, Choi Eui-Young9, Kang Woong Chol9, Oh Pyung Chun9, Lee Jong-Young9, Lee Jin-Bae9, Kim Kee Sik9, Choi Ji Yong9, Ryu Jae Kean9, Hong Seung Pyo9, Kim Chang Yeon9, Yang Tae-Hyun9, Cho Hyung-Jin9, Yoon Junghan9, Ahn Min-Soo9, Ahn Sung Gyun9, Lee Jun-Won9, Son Jung-Woo9, Jang Yangsoo9, Yoon Hyuck-Jun9, Lee Cheol Hyun9, Hwang Jongmin9, Cho Yun-Kyeong9, Hur Seung-Ho9, Han Seongwook9, Nam Chang-Wook9, Kim Hyoungseop9, Park Hyoung-Seob9, Kim In-Cheol9, Cho Yun-Hyeong9, Jeong Hyeon-Ju9, Kim Jin-Ho9, Lim Chewan9, Suh Yongsung9, Hwang Eui Seok9, Lee Ji Hyun9, Lee Sung Yun9, Kwon Sung Uk9, Kim Song-Yi9, Park Keun-Ho9, Kim Hyun Kuk9,
Affiliation:
1. Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea 2. Gangnam Severance Hospital, Seoul, South Korea 3. Gachon University College of Medicine, Incheon, South Korea 4. Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea 5. Daegu Catholic University Medical Center, Daegu, South Korea 6. Inje University Busan Paik Hospital, Busan, South Korea 7. Wonju Severance Christian Hospital, Wonju, South Korea 8. CHA University College of Medicine, Seongnam, South Korea 9. for the LODESTAR Investigators
Abstract
ImportanceIn 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.ObjectiveTo 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 ParticipantsA 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).InterventionsPatients 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 MeasuresPrimary end point was a 3-year composite of death, myocardial infarction, stroke, or coronary revascularization with a noninferiority margin of 3.0 percentage points.ResultsAmong 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 RelevanceAmong 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 RegistrationClinicalTrials.gov Identifier: NCT02579499
Publisher
American Medical Association (AMA)
Cited by
39 articles.
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