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
  • Kim, Min Chul
  • Ahn, Joon Ho
  • Hyun, Dae Young
  • Lim, Yongwhan
  • Lee, Seung Hun
  • ... Hwang, Jin-Yong
  • 외 20명
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초록

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. © 2024 The Author(s)

키워드

PERCUTANEOUS CORONARY INTERVENTIONLESION-ONLY REVASCULARIZATIONARTERY REVASCULARIZATIONRANDOMIZED-TRIALFOLLOW-UPANGIOPLASTYGUIDELINESPCI
제목
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
저자
Kim, Min ChulAhn, Joon HoHyun, Dae YoungLim, YongwhanLee, Seung HunOh, SeokCho, Kyung HoonSim, Doo SunHong, Young JoonKim, Ju HanJeong, Myung HoCho, Jang HyunLee, Sang-RokKang, Dong OhHwang, Jin-YongYoun, Young JinJeong, Young-HoonPark, YongwhiKim, Dong-BinChoo, Eun-HoKim, Chan JoonKim, WeonRhew, Jay YoungLee, Jung-HeeYoo, Sang-YongAhn, Youngkeun
DOI
10.1016/j.ahj.2024.03.017
발행일
2024-07
유형
Article
저널명
American Heart Journal
273
페이지
35 ~ 43