1. Timing of fractional flow reserve-guided complete revascularization in patients with ST-segment elevation myocardial infarction with multivessel disease: Rationale and design of the OPTION-STEMI trial.
- Author
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Kim MC, Ahn JH, Hyun DY, Lim Y, Lee SH, Oh S, Cho KH, Sim DS, Hong YJ, Kim JH, Jeong MH, Cho JH, Lee SR, Kang DO, Hwang JY, Youn YJ, Jeong YH, Park Y, Kim DB, Choo EH, Kim CJ, Kim W, Rhew JY, Lee JH, Yoo SY, and Ahn Y
- Subjects
- Female, Humans, Male, Middle Aged, Coronary Angiography, Myocardial Revascularization methods, Prospective Studies, Time Factors, Time-to-Treatment, Coronary Artery Disease physiopathology, Coronary Artery Disease surgery, Coronary Artery Disease complications, Coronary Artery Disease diagnosis, Fractional Flow Reserve, Myocardial physiology, Percutaneous Coronary Intervention methods, ST Elevation Myocardial Infarction physiopathology, ST Elevation Myocardial Infarction surgery, ST Elevation Myocardial Infarction therapy
- Abstract
Background: Current guidelines recommend complete revascularization (CR) in hemodynamically stable patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD). With regard to the timing of percutaneous coronary intervention (PCI) for non-infarct-related artery (non-IRA), recent randomized clinical trials have revealed that immediate CR was non-inferior to staged CR. However, the optimal timing of CR remains uncertain. The OPTION-STEMI trial compared immediate CR and in-hospital staged CR guided by fractional flow reserve (FFR) for intermediate stenosis of the non-IRA., Methods: The OPTION-STEMI is a multicenter, investigator-initiated, prospective, open-label, non-inferiority randomized clinical trial. The study included patients with at least 1 non-IRA lesion with ≥50% stenosis by visual estimation. Patients fulfilling the inclusion criteria were randomized into 2 groups at a 1:1 ratio: immediate CR (i.e., PCI for the non-IRA performed during primary angioplasty) or in-hospital staged CR. In the in-hospital staged CR group, PCI for non-IRA lesions was performed on another day during the index hospitalization. Non-IRA lesions with 50%-69% stenosis by visual estimation were evaluated by FFR, whereas those with ≥70% stenosis was revascularized without FFR. The primary endpoint was the composite of all-cause death, non-fatal myocardial infarction, and all unplanned revascularization at 1 year after randomization. Enrolment began in December 2019 and was completed in January 2024. The follow-up for the primary endpoint will be completed in January 2025, and primary results will be available in the middle of 2025., Conclusions: The OPTION-STEMI is a multicenter, non-inferiority, randomized trial that evaluated the timing of in-hospital CR with the aid of FFR in patients with STEMI and MVD., Trial Registration: URL: https://www., Clinicaltrials: gov. Unique identifier: NCT04626882; and URL: https://cris.nih.go.kr. Unique identifier: KCT0004457., Competing Interests: Conflicts of Interest The authors declare no disclosures or conflicts of interest., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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