作者
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,Myeong‐Ki Hong,Donghoon Choi,Young‐Guk Ko,Byeong‐Keuk Kim,Jung‐Sun Kim,Chul‐Min Ahn,Sung‐Jin Hong,Seung‐Jun Lee,Yong‐Joon Lee,Bum–Kee Hong,Hyuck Moon Kwon,Jong‐Youn Kim,Pil‐Ki Min,Young Won Yoon,Byoung Kwon Lee,Se‐Joong Rim,Eui‐Young Choi,Woong Chol Kang,Pyung Chun Oh,Jong‐Young Lee,Jin‐Bae Lee,Kee Sik Kim,Ji Yong Choi,Jae Kean Ryu,Seung Pyo Hong,Chang Yeon Kim,Tae‐Hyun Yang,Hyung-Jin Cho,Junghan Yoon,Min-Soo Ahn,Sung Gyun Ahn,Jun‐Won Lee,Jung–Woo Son,Yangsoo Jang,Hyuck‐Jun Yoon,Cheol Hyun Lee,Jongmin Hwang,Yun‐Kyeong Cho,Seung‐Ho Hur,Seongwook Han,Chang‐Wook Nam,Hyoung Seop Kim,Hyoung‐Seob Park,In‐Cheol Kim,Yun‐Hyeong Cho,Hyeon‐Ju Jeong,Jin-Ho Kim,Chewan Lim,Yongsung Suh,Euiseok Hwang,Ji‐Hyun Lee,Sung Yun Lee,Sung Uk Kwon,Song‐Yi Kim,Keun Ho Park,Hyun Kuk Kim
摘要
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.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.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).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.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.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).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.ClinicalTrials.gov Identifier: NCT02579499.