基于光学相干断层扫描引导与评估的非ST段抬高型急性冠状动脉综合征患者新一代药物洗脱支架植入术后早期血管愈合情况（EXPECT）：一项随机对照试验的研究方案
Early vascular healing after neXt-generation drug-eluting stent implantation in Patients with non-ST Elevation acute Coronary syndrome based on optical coherence Tomography guidance and evaluation (EXPECT): study protocol for a randomized controlled trial.
作者信息
Zhu Yong-Xiang, Liang Li, Parasa Ramya, Li Zheng, Li Qian, Chang Shang, Ma Wen-Rui, Feng Si-Li, Wang Yang, Xu Bo, Bourantas Christos V, Zhang Yao-Jun
机构信息
Department of Cardiology, Xuzhou Third People's Hospital, Xuzhou Medical University, Xuzhou, China.
Department of Cardiology, Barts Heart Center, Barts Health NHS Trust, London, United Kingdom.
出版信息
Front Cardiovasc Med. 2023 Feb 23;10:1003546. doi: 10.3389/fcvm.2023.1003546. eCollection 2023.
BACKGROUND
There is limited evidence about vessel wall healing response following implantation of next-generation drug-eluting stents (DES) in patients admitted with a non-ST elevation acute coronary syndrome (NSTE-ACS). Cumulative data indicate that optical coherence tomography (OCT) imaging can optimize percutaneous coronary intervention results and expedite stent endothelialization in the general population but there is lack of data in NSTE-ACS patients.
METHODS
The EXPECT study is an investigator-initiated, prospective, randomized trial to assess early vascular healing response following next-generation DES implantation in patients admitted with NSTE-ACS based on OCT guidance and evaluation. Sixty patients are randomized at 1:1:1 ratio to OCT-guided percutaneous coronary intervention (PCI) with 3-month follow-up OCT imaging (O3 group, = 20), to angiography-guided PCI with 3-month follow-up OCT imaging (A3 group, = 20) and to angiography-guided PCI with 6-month follow-up OCT imaging (A6 group, = 20). The primary endpoint of the study is stent strut coverage rate at 3- or 6- month follow-up in the studied groups. The secondary endpoints of the study include OCT imaging endpoints, clinical endpoints, and molecular biology endpoints at the different time points. The clinical endpoints comprised of major cardiovascular adverse events and individual components. The molecular biology endpoints comprised of lipid levels and the levels of inflammatory indicators.
DISCUSSION
The findings of the EXPECT study are anticipated to provide novel insights into vessel wall healing in NSTE-ACS population following implantation of next-generation DES, underscore the value of OCT imaging in expediting strut coverage in this setting, and explore the potential of an early discontinuation of dual antiplatelet therapy (DAPT) in this population.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT04375319.
背景
关于下一代药物洗脱支架（DES）植入非ST段抬高型急性冠状动脉综合征（NSTE-ACS）患者后的血管壁愈合反应，证据有限。累积数据表明，光学相干断层扫描（OCT）成像可优化经皮冠状动脉介入治疗结果并加速普通人群的支架内皮化，但NSTE-ACS患者缺乏相关数据。
方法
EXPECT研究是一项由研究者发起的前瞻性随机试验，旨在评估基于OCT指导和评估的下一代DES植入NSTE-ACS患者后的早期血管愈合反应。60例患者按1:1:1比例随机分为OCT引导下经皮冠状动脉介入治疗（PCI）并进行3个月随访OCT成像组（O3组，n = 20）、血管造影引导下PCI并进行3个月随访OCT成像组（A3组，n = 20）和血管造影引导下PCI并进行6个月随访OCT成像组（A6组，n = 20）。研究的主要终点是研究组在3个月或6个月随访时的支架小梁覆盖率。研究的次要终点包括不同时间点的OCT成像终点、临床终点和分子生物学终点。临床终点包括主要心血管不良事件及其各个组成部分。分子生物学终点包括血脂水平和炎症指标水平。
讨论
预计EXPECT研究的结果将为下一代DES植入后NSTE-ACS人群的血管壁愈合提供新的见解，强调OCT成像在加速该情况下小梁覆盖方面的价值，并探索该人群早期停用双联抗血小板治疗（DAPT）的潜力。
临床试验注册
ClinicalTrials.gov，NCT04375319。
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