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      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

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          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.

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          Most cited references37

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          OUP accepted manuscript

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            Clinical end points in coronary stent trials: a case for standardized definitions.

            Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation. The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, in Washington, DC, in January 2006 and in Dublin, Ireland, in June 2006, sponsored by the Academic Research Consortium and including representatives of the US Food and Drug Administration and all device manufacturers who were working with the Food and Drug Administration on drug-eluting stent clinical trial programs, were focused on consensus end point definitions for drug-eluting stent evaluations. The effort was pursued with the objective to establish consistency among end point definitions and provide consensus recommendations. On the basis of considerations from historical legacy to key pathophysiological mechanisms and relevance to clinical interpretability, criteria for assessment of death, myocardial infarction, repeat revascularization, and stent thrombosis were developed. The broadly based consensus end point definitions in this document may be usefully applied or recognized for regulatory and clinical trial purposes. Although consensus criteria will inevitably include certain arbitrary features, consensus criteria for clinical end points provide consistency across studies that can facilitate the evaluation of safety and effectiveness of these devices.
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              2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non–ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery

              Circulation, 134(10)
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                Author and article information

                Contributors
                Journal
                Front Cardiovasc Med
                Front Cardiovasc Med
                Front. Cardiovasc. Med.
                Frontiers in Cardiovascular Medicine
                Frontiers Media S.A.
                2297-055X
                23 February 2023
                2023
                23 February 2023
                : 10
                : 1003546
                Affiliations
                [1] 1Department of Cardiology, Xuzhou Third People’s Hospital, Xuzhou Medical University , Xuzhou, China
                [2] 2Department of Cardiology, Barts Heart Center, Barts Health NHS Trust , London, United Kingdom
                [3] 3Cardiovascular Devices Hub, Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London , London, United Kingdom
                [4] 4Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College , Beijing, China
                Author notes

                Edited by: Tommaso Gori, Johannes Gutenberg University Mainz, Germany

                Reviewed by: Peiren Shan, First Affiliated Hospital of Wenzhou Medical University, China; Ankush Gupta, Army Institute of Cardiothoracic Sciences (AICTS), India

                *Correspondence: Yao-Jun Zhang, ✉ 13770668667@ 123456139.com

                These authors have contributed equally to this work

                ORCID: Yao-Jun Zhang, https://orcid.org/0000-0001-8357-5544

                This article was submitted to Coronary Artery Disease, a section of the journal Frontiers in Cardiovascular Medicine

                Article
                10.3389/fcvm.2023.1003546
                9995825
                36910518
                f419e703-37bc-453b-b4ab-cd1e458163c5
                Copyright © 2023 Zhu, Liang, Parasa, Li, Li, Chang, Ma, Feng, Wang, Xu, Bourantas and Zhang.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 26 July 2022
                : 06 February 2023
                Page count
                Figures: 2, Tables: 4, Equations: 0, References: 37, Pages: 8, Words: 6037
                Funding
                Funded by: 333 High-level Talent Training Program of Jiangsu Province
                Award ID: BAR2018275
                Award ID: 2019-TPRC-1
                Categories
                Cardiovascular Medicine
                Study Protocol

                non-st elevation acute coronary syndrome,optical coherence tomography,percutaneous coronary intervention,early vascular healing,stent struts coverage

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