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.
Am Heart J
; 273: 35-43, 2024 07.
Article
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| MEDLINE
| ID: mdl-38641031
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 11 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.
Texto completo:
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Base de datos:
MEDLINE
Asunto principal:
Enfermedad de la Arteria Coronaria
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Reserva del Flujo Fraccional Miocárdico
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Intervención Coronaria Percutánea
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Infarto del Miocardio con Elevación del ST
Límite:
Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Am Heart J
Año:
2024
Tipo del documento:
Article