Rationale and design of a randomized controlled trial: The effect of intensive lipid-lowering therapy with PCSK9 inhibitor on endothelial-coverage of stent strut after percutaneous coronary intervention (PCI) for patients with acute coronary syndrome (ACS): Optical coherence tomography (OCT) study (PIECES-OCT study)
Zheng Yin,
Zhi-Fan Li,
Wen-Jia Zhang,
Shuang Zhang,
Yong-Gang Sui,
Yan-Lu Xu,
Hai-Tao Zhang,
Xiao-Ning Liu,
Hong Qiu,
Jing-Lin Zhao,
Jian-Jun Li,
Ke-Fei Dou,
Jie Qian,
Yong-Jian Wu,
Na-Qiong Wu
Affiliations
Zheng Yin
Cardiometabolic Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, 100037, Beijing, China
Zhi-Fan Li
Cardiometabolic Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, 100037, Beijing, China
Wen-Jia Zhang
Cardiometabolic Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, 100037, Beijing, China
Shuang Zhang
Cardiometabolic Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, 100037, Beijing, China
Yong-Gang Sui
Cardiometabolic Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, 100037, Beijing, China
Yan-Lu Xu
Cardiometabolic Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, 100037, Beijing, China
Hai-Tao Zhang
Cardiometabolic Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, 100037, Beijing, China
Xiao-Ning Liu
Cardiometabolic Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, 100037, Beijing, China
Hong Qiu
Cardiometabolic Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, 100037, Beijing, China
Jing-Lin Zhao
Cardiometabolic Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, 100037, Beijing, China
Jian-Jun Li
Cardiometabolic Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, 100037, Beijing, China
Ke-Fei Dou
Cardiometabolic Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, 100037, Beijing, China
Jie Qian
Cardiometabolic Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, 100037, Beijing, China
Yong-Jian Wu
Corresponding author. Center of Coronary Heart Disease, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science and Peking Union Medical College, No 167 BeiLiShi Road, XiCheng District, Beijing, 100037, China.; Cardiometabolic Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, 100037, Beijing, China
Na-Qiong Wu
Corresponding author. Cardiometabolic Medicine Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science and Peking Union Medical College, No 167 BeiLiShi Road, XiCheng District, Beijing, 100037, China.; Cardiometabolic Center, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Science & Peking Union Medical College, 100037, Beijing, China
Background: For the patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI), dual antiplatelet therapy (DAPT) for at least 1 year is recommended in the guidelines to minimize the risk of stent thrombosis. Persistently uncovered stent strut means delayed neointima formation and extend the window of time in which the stent is prone to thrombosis. Previous studies showed that statins could improve post-stenting strut endothelial coverage for patients undergoing PCI. However, there are lack of evidences on whether early initiation of proprotein convertase subtilisin/Kexin type 9 monoclonal antibody (PCSK9mAb) after PCI in ACS patients can further improve the rate of stent strut coverage on the background of oral lipid-lowering therapy (LLT). Methods: This is a single-center, randomized trial to enroll 36 patients undergoing PCI with a clinical diagnosis of non-ST-segment elevation ACS. The baseline level of low-density lipoprotein cholesterol (LDL-C) of these patients are between 1.4 mmol/L and 3.4 mmol/L. Patients will be assigned to intensive lipid-lowering therapy (LLT) with PCSK9mAb group and conventional LLT without PCSK9mAb group for 12 weeks in a clinical follow-up setting according to 1: 1 randomization. the rate of stent strut endothelial coverage by optical coherence tomography (OCT) examination at 12 weeks after enrollment between the groups will be compared. Conclusion: This will be the first study to investigate changes in the rate of stent strut endothelial coverage under intensive LLT with PCSK9mAb by OCT examination in ACS patients undergoing PCI. The finding of this study will provide clinical evidence for future research about the hypothesis of a novel strategy of “intensive LLT (PCSK9mAb + statin ± ezetimibe) combined with shortened DAPT duration” for ACS patients undergoing PCI.Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: ChiCTR2200063395.
