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

Yong-Xiang Zhu; Li Liang; Ramya Parasa; Zheng Li; Qian Li; Shang Chang; Wen-Rui Ma; Si-Li Feng; Yang Wang; Bo Xu; Christos V Bourantas; Yao-Jun Zhang

doi:10.3389/fcvm.2023.1003546

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

Front Cardiovasc Med. 2023 Feb 23:10:1003546. doi: 10.3389/fcvm.2023.1003546. eCollection 2023.

Authors

Yong-Xiang Zhu¹, Li Liang¹, Ramya Parasa^{2

3}, Zheng Li¹, Qian Li¹, Shang Chang¹, Wen-Rui Ma¹, Si-Li Feng¹, Yang Wang⁴, Bo Xu⁴, Christos V Bourantas^{2

3}, Yao-Jun Zhang¹

Affiliations

¹ Department of Cardiology, Xuzhou Third People's Hospital, Xuzhou Medical University, Xuzhou, China.
² Department of Cardiology, Barts Heart Center, Barts Health NHS Trust, London, United Kingdom.
³ Cardiovascular Devices Hub, Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London, London, United Kingdom.
⁴ Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Abstract

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, n = 20), to angiography-guided PCI with 3-month follow-up OCT imaging (A3 group, n = 20) and to angiography-guided PCI with 6-month follow-up OCT imaging (A6 group, n = 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.

Keywords: early vascular healing; non-ST elevation acute coronary syndrome; optical coherence tomography; percutaneous coronary intervention; stent struts coverage.

Associated data

ClinicalTrials.gov/NCT04375319