Lancet (London, England) · 2025
Immediate versus staged complete revascularisation during index admission in patients with ST-segment elevation myocardial infarction and multivessel disease (OPTION-STEMI): a multicentre, non-inferiority, open-label, randomised trial.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеEquivalence TrialСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Kim Min Chul, Ahn Joon Ho, Hyun Dae Young, Lim Yongwhan, Cho Kyung Hoon, Lee Seung Hun, Park Seongho, Oh Seok, Sim Doo Sun, Hong Young Joon, Kim Ju Han, Jeong Myung Ho, Cho Jang Hyun, Lee Sang-Rok, Kang Dong Oh, Hwang Jin-Yong, Youn Young Jin, Lee Jung-Hee, Jeong Young-Hoon, Ahn Jong-Hwa, Kim Dong-Bin, Choo Eun Ho, Kim Chan Joon, Kim Weon, Rhew Jay Young, Park Jong-Il, Yoo Sang-Yong, Ahn Youngkeun, OPTION–STEMI Investigators
Аннотация
BACKGROUND: The optimal timing of complete revascularisation for patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease remains unclear. We aimed to assess whether immediate complete revascularisation was non-inferior to staged complete revascularisation during the index admission.
METHODS: We conducted an open-label, randomised, non-inferiority trial at 14 hospitals in South Korea. Patients aged 19 years or older with STEMI and multivessel disease who had undergone percutaneous coronary intervention (PCI) for a culprit lesion were randomly assigned 1:1 to immediate complete revascularisation (PCI for non-culprit lesions during the index procedure) or staged complete revascularisation (non-culprit PCI on another day during the index admission). Web-based, permuted-block randomisation (using mixed block sizes of two or four) was implemented at each participating centre to allocate patients. Non-culprit lesions with 50-69% stenosis were evaluated by fractional flow reserve. Study participants and study investigators were aware of treatment allocation, but members of the independent clinical committee reviewing primary and secondary endpoints were masked to treatment allocation. The primary endpoint was a composite of death from any cause, non-fatal myocardial infarction, or any unplanned revascularisation at 1 year in the intention-to-treat population, and the non-inferiority margin was set at a hazard ratio (HR) of 1·42; if the upper boundary of the one-sided 97·5% CI of the HR was less than 1·42, immediate complete revascularisation would be considered non-inferior to staged complete revascularisation. Reported adverse events consisted of procedural complications, other complications during admission, and in-hospital clinical events occurring during the index admission. This trial is registered with the Clinical Research Information Service (KCT0004457) and ClinicalTrials.gov (NCT04626882). Long-term follow-up is ongoing.
FINDINGS: Between Dec 30, 2019, and Jan 15, 2024, 994 patients were enrolled and randomly assigned to immediate revascularisation (n=498; immediate group) or staged revascularisation (n=496; staged group). The primary endpoint occurred at 1 year in 65 patients (13%) in the immediate group and 53 patients (11%) in the staged group (HR 1·24 [95% CI 0·86-1·79]; pnon-inferiority=0·24). Rates of stroke, major bleeding, and contrast-induced nephropathy did not differ significantly between the two groups. Cardiogenic shock during the index hospitalisation occurred in 18 (4%) of 498 patients in the immediate group and nine (2%) of 496 patients in the staged complete revascularisation group.
INTERPRETATION: Among patients with STEMI and multivessel disease, immediate complete revascularisation was not shown to be non-inferior to staged complete revascularisation during the index admission in terms of incidence of a composite of death from any cause, non-fatal myocardial infarction, or any unplanned revascularisation at 1 year. This finding might inform future clinical guidelines on the role and optimal use of immediate complete revascularisation during the index admission.
FUNDING: Boston Scientific.
METHODS: We conducted an open-label, randomised, non-inferiority trial at 14 hospitals in South Korea. Patients aged 19 years or older with STEMI and multivessel disease who had undergone percutaneous coronary intervention (PCI) for a culprit lesion were randomly assigned 1:1 to immediate complete revascularisation (PCI for non-culprit lesions during the index procedure) or staged complete revascularisation (non-culprit PCI on another day during the index admission). Web-based, permuted-block randomisation (using mixed block sizes of two or four) was implemented at each participating centre to allocate patients. Non-culprit lesions with 50-69% stenosis were evaluated by fractional flow reserve. Study participants and study investigators were aware of treatment allocation, but members of the independent clinical committee reviewing primary and secondary endpoints were masked to treatment allocation. The primary endpoint was a composite of death from any cause, non-fatal myocardial infarction, or any unplanned revascularisation at 1 year in the intention-to-treat population, and the non-inferiority margin was set at a hazard ratio (HR) of 1·42; if the upper boundary of the one-sided 97·5% CI of the HR was less than 1·42, immediate complete revascularisation would be considered non-inferior to staged complete revascularisation. Reported adverse events consisted of procedural complications, other complications during admission, and in-hospital clinical events occurring during the index admission. This trial is registered with the Clinical Research Information Service (KCT0004457) and ClinicalTrials.gov (NCT04626882). Long-term follow-up is ongoing.
FINDINGS: Between Dec 30, 2019, and Jan 15, 2024, 994 patients were enrolled and randomly assigned to immediate revascularisation (n=498; immediate group) or staged revascularisation (n=496; staged group). The primary endpoint occurred at 1 year in 65 patients (13%) in the immediate group and 53 patients (11%) in the staged group (HR 1·24 [95% CI 0·86-1·79]; pnon-inferiority=0·24). Rates of stroke, major bleeding, and contrast-induced nephropathy did not differ significantly between the two groups. Cardiogenic shock during the index hospitalisation occurred in 18 (4%) of 498 patients in the immediate group and nine (2%) of 496 patients in the staged complete revascularisation group.
INTERPRETATION: Among patients with STEMI and multivessel disease, immediate complete revascularisation was not shown to be non-inferior to staged complete revascularisation during the index admission in terms of incidence of a composite of death from any cause, non-fatal myocardial infarction, or any unplanned revascularisation at 1 year. This finding might inform future clinical guidelines on the role and optimal use of immediate complete revascularisation during the index admission.
FUNDING: Boston Scientific.