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
- 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.
- All Author(s)
- 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
- Issued Date
- 2023
- Type
- Article
- Keyword
- Dyslipidaemias; Hydroxymethylglutaryl-CoA reductase inhibitors; Percutaneous coronary intervention
- Publisher
- The Lancet
- ISSN
- 2589-5370
- Citation Title
- EClinicalMedicine
- Citation Volume
- 58
- Citation Start Page
- 101933
- Citation End Page
- 101933
- Language(ISO)
- eng
- DOI
- 10.1016/j.eclinm.2023.101933
- URI
- http://schca-ir.schmc.ac.kr/handle/2022.oak/3389
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