Fully Automated Quantitative Coronary Angiography Versus Optical Coherence Tomography Guidance for Coronary Stent Implantation (FLASH): Study Protocol for a Randomized Controlled Non-Inferiority Trial

Yongcheol Kim; Hanbit Park; Hyuck-Jun Yoon; Jon Suh; Si-Hyuck Kang; Young-Hyo Lim; Duck Hyun Jang; Jae Hyoung Park; Eun-Seok Shin; Jang-Whan Bae; Jang Hoon Lee; Jun-Hyok Oh; Do-Yoon Kang; Jihoon Kweon; Min-Woo Jo; Duk-Woo Park; Young-Hak Kim; Jung-Min Ahn; FLASH Trial Investigators

doi:10.1016/j.ahj.2024.05.004

Fully Automated Quantitative Coronary Angiography Versus Optical Coherence Tomography Guidance for Coronary Stent Implantation (FLASH): Study Protocol for a Randomized Controlled Non-Inferiority Trial

Am Heart J. 2024 May 7:S0002-8703(24)00119-4. doi: 10.1016/j.ahj.2024.05.004. Online ahead of print.

Authors

Yongcheol Kim¹, Hanbit Park², Hyuck-Jun Yoon³, Jon Suh⁴, Si-Hyuck Kang⁵, Young-Hyo Lim⁶, Duck Hyun Jang⁷, Jae Hyoung Park⁸, Eun-Seok Shin⁹, Jang-Whan Bae¹⁰, Jang Hoon Lee¹¹, Jun-Hyok Oh¹², Do-Yoon Kang¹³, Jihoon Kweon¹⁴, Min-Woo Jo¹⁵, Duk-Woo Park¹³, Young-Hak Kim¹³, Jung-Min Ahn¹⁶; FLASH Trial Investigators

Affiliations

¹ Yonsei University College of Medicine and Cardiovascular Center, Yongin Severance Hospital, Yongin, Korea.
² Division of Cardiology, Department of Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Korea.
³ Department osf Internal Medicine and Cardiovascular Research Institute, Keimyung University Dongsan Hospital, Daegu, Korea.
⁴ Department of Cardiology, Soon Chun Hyang University Hospital Bucheon, Bucheon, Korea.
⁵ Cardiovascular Center, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
⁶ Division of Cardiology, Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.
⁷ Division of Cardiology, Department of Internal Medicine, Sejong General Hospital, Bucheon, Korea.
⁸ Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
⁹ Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
¹⁰ Division of Cardiology, Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, Korea.
¹¹ Department of Internal Medicine, Kyungpook National University Hospital, School of Medicine, Kyungpook National University, Daegu, Korea.
¹² Pusan National University, Department of Cardiology and Medical Research Institute, Pusan, National University Hospital, Busan, Korea.
¹³ Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
¹⁴ Department of Convergence Medicine, Asan Medical Center, Seoul, Republic of Korea.
¹⁵ Department of Preventive Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
¹⁶ Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. Electronic address: drjmahn@gmail.com.

PMID: 38723880
DOI: 10.1016/j.ahj.2024.05.004

Abstract

Background: Artificial intelligence-based quantitative coronary angiography (AI-QCA) has been developed to provide a more objective and reproducible data about the severity of coronary artery stenosis and the dimensions of the vessel for intervention in real-time, overcoming the limitations of significant inter- and intra-observer variability, and time-consuming nature of on-site QCA, without requiring extra time and effort. Compared with the subjective nature of visually estimated conventional CAG guidance, AI-QCA guidance provides a more practical and standardized angiography-based approach. Although the advantage of intravascular imaging-guided PCI is increasingly recognized, their broader adoption is limited by clinical and economic barriers in many catheterization laboratories.

Methods: The FLASH (Fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation) trial is a randomized, investigator-initiated, multicenter, open-label, non-inferiority trial comparing the AI-QCA-assisted PCI strategy with optical coherence tomography-guided PCI strategy in patients with significant coronary artery disease. All operators will utilize a novel, standardized AI-QCA software and PCI protocol in the AI-QCA-assisted group. A total of 400 patients will be randomized to either group at a 1:1 ratio. The primary endpoint is the minimal stent area (mm2), determined by the final OCT run after completion of PCI. Clinical follow-up and cost-effectiveness evaluations are planned at 1 month and 6 months for all patients enrolled in the study.

Results: Enrollment of a total of 400 patients from the 13 participating centers in South Korea will be completed in February 2024. Follow-up of the last enrolled patients will be completed in August 2024, and primary results will be available by late 2024.

Conclusion: The FLASH is the first clinical trial to evaluate the feasibility of AI-QCA-assisted PCI, and will provide the clinical evidence on AI-QCA assistance in the field of coronary intervention.

Keywords: artificial intelligence; coronary imaging; coronary intervention; quantitative coronary angiography; stent.