Clinical Trials Study
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Cardiol. Nov 26, 2018; 10(11): 222-233
Published online Nov 26, 2018. doi: 10.4330/wjc.v10.i11.222
Safety and efficacy of frequency-domain optical coherence tomography in evaluating and treating intermediate coronary lesions
Mohammad Reeaze Khurwolah, Hao-Yu Meng, Yong-Sheng Wang, Lian-Sheng Wang, Xiang-Qing Kong
Mohammad Reeaze Khurwolah, Hao-Yu Meng, Yong-Sheng Wang, Lian-Sheng Wang, Xiang-Qing Kong, Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, Jiangsu Province, China
Author contributions: Khurwolah MR, Meng HY, Wang YS, Wang LS and Kong XQ designed the research; Khurwolah MR, Meng HY and Wang LS performed the research; Khurwolah MR, Wang YS and Kong XQ analyzed the data; Khurwolah MR and Meng HY contributed equally to the study; Wang LS and Kong XQ supervised the study to an equal extent in the capacity of senior cardiology consultants; Khurwolah MR wrote the paper.
Supported by the National Natural Science Foundation of China, No. 81570363; the National Key Research and Development Program of China, No. 2016YFA0201304; and the Priority Academic Program Development of Jiangsu Higher Education Institutions, No. KYZZ15_0263.
Institutional review board statement: The study protocol was reviewed and approved by the ethics committee of the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China (Ethics Approval ID: 2017-SR-328).
Clinical trial registration statement: The study is registered in the ClinicalTrials.gov Protocol Registration and Results System (PRS). ClinicalTrials.gov ID: NCT03229993.
Informed consent statement: All participants in the study provided informed consent, and the investigation was conducted in accordance with the World Medical Association Declaration of Helsinki.
Conflict-of-interest statement: The authors have no conflicts of interest to disclose.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The guidelines of the CONSORT 2010 Statement have been adopted in this study.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author to: Xiang-Qing Kong, MD, PhD, Full Professor, Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, 300 Guangzhou Road, Nanjing 210029, Jiangsu Province, China. kongxq@njmu.edu.cn
Telephone: +86-139-51610265
Received: August 14, 2018
Peer-review started: August 14, 2018
First decision: September 7, 2018
Revised: September 8, 2018
Accepted: November 2, 2018
Article in press: November 2, 2018
Published online: November 26, 2018
Processing time: 103 Days and 16.7 Hours
Abstract
AIM

To establish whether frequency-domain optical coherence tomography (FD-OCT) is safe and effective in the evaluation and treatment of angiographically-intermediate coronary lesions (ICL)

METHODS

Sixty-four patients with 2-dimensional quantitative coronary angiography (2D-QCA) demonstrating ICL were included. OCT imaging was performed. According to predetermined OCT criteria, patients were assigned to either of 2 groups: OCT-guided percutaneous coronary intervention (PCI) or OCT-guided optimal medical therapy (OMT). The primary efficacy endpoint was to demonstrate the superiority and higher accuracy of FD-OCT compared to 2D-QCA in evaluating stenosis severity in patients with ICL. The primary safety endpoint was the incidence of 30-d major adverse cardiac events (MACE). Secondary endpoints included MACE at 12 mo and other clinical events.

RESULTS

Analysis of the primary efficacy endpoint demonstrates that 2D-QCA overestimates the stenosis severity of ICL in both the OCT-guided PCI and OMT groups, proving FD-OCT to be superior to and more precise than 2D-QCA in treating this subset of lesions. The primary safety endpoint was fully met with the incidence of 30-d MACE being nil in both the OCT-guided PCI and OCT-guided OMT groups. Incidences of secondary endpoints were found to be low in both arms, the only exception being the relatively high incidence of recurrent episodes of angina which was, however, very similar in the 2 groups.

CONCLUSION

FD-OCT is safe and effective in the evaluation and treatment of ICL. Larger studies are needed to firmly establish the efficacy and safety of FD-OCT in treating ICL across all coronary artery disease population subgroups.

Keywords: Percutaneous coronary intervention; 2-dimensional quantitative coronary angiography; Frequency-domain optical coherence tomography; Intermediate coronary lesions; Optical coherence tomography

Core tip: The management of intermediate coronary lesions (ICL), defined as a diameter stenosis of 40% to 70%, remains a therapeutic dilemma. The 2-dimensional representation of the arterial lesion by angiography is limited in guiding therapy. Frequency-domain optical coherence tomography (FD-OCT) is an ultra-high resolution imaging technique that enables a detailed evaluation of the coronary lumen. Despite its undebatable superiority over angiography and other intravascular imaging techniques, the benefit of FD-OCT over its procedural risks in clinical practice is uncertain. The current study is the first to date to investigate whether FD-OCT is safe and effective in the evaluation of ICL, in guiding treatment, and optimizing procedural outcomes.