Abstract Objective To compare the long term efficacy and safety of rosuvastatin with atorvastatin treatment in adults with coronary artery disease. Design Randomised, open label, multicentre trial. Setting 12 hospitals in South Korea, September 2016 to November 2019. Participants 4400 adults (age ≥19 years) with coronary artery disease. Interventions Participants were assigned to receive either rosuvastatin (n=2204) or atorvastatin (n=2196) using 2×2 factorial randomisation. Main outcome measures The primary outcome was a three year composite of all cause death, myocardial infarction, stroke, or any coronary revascularisation. Secondary outcomes were safety endpoints: new onset diabetes mellitus; hospital admissions due to heart failure; deep vein thrombosis or pulmonary thromboembolism; endovascular revascularisation for peripheral artery disease; aortic intervention or surgery; end stage kidney disease; discontinuation of study drugs owing to intolerance; cataract surgery; and a composite of laboratory detected abnormalities. Results 4341 of the 4400 participants (98.7%) completed the trial. Mean daily dose of study drugs was 17.1 mg (standard deviation (SD) 5.2 mg) in the rosuvastatin group and 36.0 (12.8) mg in the atorvastatin group at three years (P<0.001). The primary outcome occurred in 189 participants (8.7%) in the rosuvastatin group and 178 (8.2%) in the atorvastatin group (hazard ratio 1.06, 95% confidence interval 0.86 to 1.30; P=0.58). The mean low density lipoprotein (LDL) cholesterol level during treatment was 1.8 mmol/L (SD 0.5 mmol/L) in the rosuvastatin group and 1.9 (0.5) mmol/L in the atorvastatin group (P<0.001). The rosuvastatin group had a higher incidence of new onset diabetes mellitus requiring initiation of antidiabetics (7.2% v 5.3%; hazard ratio 1.39, 95% confidence interval 1.03 to 1.87; P=0.03) and cataract surgery (2.5% v 1.5%; 1.66, 1.07 to 2.58; P=0.02). Other safety endpoints did not differ between the two groups. Conclusions In adults with coronary artery disease, rosuvastatin and atorvastatin showed comparable efficacy for the composite outcome of all cause death, myocardial infarction, stroke, or any coronary revascularisation at three years. Rosuvastatin was associated with lower LDL cholesterol levels but a higher risk of new onset diabetes mellitus requiring antidiabetics and cataract surgery compared with atorvastatin. Trial registration ClinicalTrials.gov NCT02579499 .
SHOW FULL ABSTRACT Yong-Joon Lee, Sung-Jin Hong, Woong Chol Kang, Bum-Kee Hong, Jong-Young Lee, Jin-Bae Lee, Hyung-Jin Cho, Junghan Yoon, Seung-Jun Lee, 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, Hyoungseop Kim, Hyoung-Seob Park, In-Cheol Kim, Yun-Hyeong Cho, Hyeon-Ju Jeong, Jin-Ho Kim, Chewan Lim, Yongsung Suh, Eui Seok Hwang, Ji Hyun Lee, Sung Yun Lee, Sung Uk Kwon, Song-Yi Kim, Keun-Ho Park, Hyun Kuk Kim
1Division of Cardiology, Severance Hospital, Yonsei University College of Medicine, Seodaemun-gu, 03722, Seoul, Korea 2Gachon University College of Medicine, Incheon, Korea 3Gangnam Severance Hospital, Seoul, Korea 4Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea 5Daegu Catholic University Medical Centre, Daegu, Korea 6Inje University Busan Paik Hospital, Busan, Korea 7Wonju Severance Christian Hospital, Wonju, Korea 8CHA University College of Medicine, Seongnam, Korea 