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Efficacy and safety of moderate-intensity statin with ezetimibe combination therapy in patients after percutaneous coronary intervention: a post-hoc analysis of the RACING trial

Authors
 Jong-Il Park  ;  Seung-Jun Lee  ;  Bum-Kee Hong  ;  Yun-Hyeong Cho  ;  Won-Yong Shin  ;  Sang-Wook Lim  ;  Woong-Chol Kang  ;  Yongwhi Park  ;  Sung-Yoon Lee  ;  Yong-Joon Lee  ;  Sung-Jin Hong  ;  Chul-Min Ahn  ;  Byeong-Keuk Kim  ;  Young-Guk Ko  ;  Donghoon Choi  ;  Myeong-Ki Hong  ;  Yangsoo Jang  ;  Jung-Sun Kim  ;  RACING investigators 
Citation
 ECLINICALMEDICINE, Vol.58 : 101933, 2023-04 
Journal Title
ECLINICALMEDICINE
Issue Date
2023-04
Keywords
Dyslipidaemias ; Hydroxymethylglutaryl-CoA reductase inhibitors ; Percutaneous coronary intervention\
Abstract
Background: Moderate-intensity statin role with ezetimibe combination therapy following percutaneous coronary intervention (PCI) has not been thoroughly investigated, particularly compared to high-intensity statin monotherapy. We aimed to investigate the effect of ezetimibe combination with moderate-intensity statin in patients with atherosclerotic cardiovascular disease following PCI.

Methods: This was a post-hoc analysis of a subset of patients who underwent PCI in the RACING trial. At 26 centres in South Korea, patients with atherosclerotic cardiovascular disease (ASCVD) were randomly assigned to receive either moderate-intensity statin with ezetimibe combination therapy (rosuvastatin 10 mg with ezetimibe 10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg). The prespecified endpoints of the RACING trial were used. The primary endpoint was the 3-year composite of cardiovascular death, major cardiovascular events, and nonfatal stroke. Event rates between the two groups were compared using log-rank tests, and hazard ratios (HR) with 95% confidence intervals (CI) were estimated using Cox regression analysis. Consistent with the RACING trial, the primary and secondary efficacy endpoints were evaluated using an intention-to-treatment approach, and the safety endpoints were assessed in the safety population. The RACING trial was registered at ClinicalTrials.gov (NCT03044665).

Findings: Between Feb 14, 2017, and Dec 18, 2018, 3780 participants were enrolled in the RACING trial. Prior history of PCI was found in 2497 patients (67%, median 64 years, 79% male), and was associated with higher rates of the primary endpoint (hazard ratio [HR], 1.34; 95% confidence interval [CI], 1.06–1.69; p = 0.014). Among patients with prior PCI, moderate-intensity statin therapy with ezetimibe combination versus high-intensity statin therapy did not increase the risk of the primary endpoint (HR, 0.95; 95% CI, 0.74–1.24; p = 0.781). The proportion of patients with low-density lipoprotein cholesterol (LDL-C) <70 mg/dL at 1, 2, and 3 years was 74%, 76%, and 73%, respectively, in the combination therapy group, and was significantly higher than that in the high-intensity statin monotherapy group (57%, 62%, and 59%, respectively, all p < 0.001). Discontinuation of lipid-lowering drugs occurred less frequently in the combination group (4.2% vs. 7.6%, p = 0.001).

Interpretation: The effects of ezetimibe combination therapy observed in the RACING trial were consistently preserved among patients with ASCVD following PCI. Ezetimibe combination could be considered as a suitable therapeutic strategy to achieve strict control of LDL-C and reduce drug intolerance in patients who underwent PCI.

Funding: Hanmi Pharmaceutical, Seoul, South Korea © 2026 The Author(s)
Files in This Item:
T202302887.pdf Download
DOI
10.1016/j.eclinm.2023.101933
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/22282913/195284
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