EClinicalMedicine (Apr 2023)

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

  • 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,
  • Jong-Il Park,
  • Seung-Jun Lee,
  • Yong-Joon Lee,
  • Sung-Jin Hong,
  • Chul-Min Ahn,
  • Byeong-Keuk Kim,
  • Young-Guk Ko,
  • Donghoon Choi,
  • Myeong-Ki Hong,
  • Jung-Sun Kim,
  • Bum-Kee Hong,
  • Jung-Hee Lee,
  • Ung Kim,
  • Yun-Hyeong Cho,
  • Won-Yong Shin,
  • Sang-Wook Yangsoo Lim Jang,
  • Woong-Chol Kang,
  • Yongwhi Young Hoon Park Jung,
  • Sung-Yoon Lee,
  • Kyoung Jin Kim,
  • Soon-Jun Hong,
  • Kyeong Ho Yun,
  • Jung Ho Heo,
  • Seung-Woon Rha,
  • Woong Gil Choi,
  • Wang Soo Lee Lee,
  • Jinok Jung,
  • Sunghoon Choi,
  • Youn Haeng Cho,
  • Woo Jung Park,
  • Changhwan Youn,
  • Seung Ho Hur,
  • Hyun Hee Choi,
  • Ju Han Kim,
  • Hyun Kuk Kim,
  • Yu-Jung Choi

Journal volume & issue
Vol. 58
p. 101933

Abstract

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Summary: 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

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