August 31, 2025The Lancet
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
Min Chul KimJoon Ho AhnDae Young HyunYongwhan LimKyung Hoon ChoSeung Hun LeeSeongho ParkSeok Kyu OhDoo Sun SimYoung Joon HongJu Han KimMyung Ho JeongJang Hyun ChoSang Rok LeeDong Oh KangJin‐Yong HwangYoung Jin YounJung‐Hee LeeYoung–Hoon JeongJong‐Hwa AhnDong‐Bin KimEun Ho ChooChan Joon KimWeon KimJay Young RhewJong‐Il ParkSang‐Yong YooYoungkeun Ahn
Key result
Immediate complete PCI fails to show noninferiority to staged PCI for major events at one year.
- HR 1.24
- 95% CI 0.86-1.79
- P=0.24 for noninferiority
- n=994
Why the study?
The optimal timing of complete revascularisation for patients with STEMI and multivessel coronary artery disease remains unclear.
Does immediate complete revascularisation reduce the composite of death, non-fatal myocardial infarction, or unplanned revascularisation compared to staged complete revascularisation in patients with STEMI and multivessel disease?
Key Points
- To evaluate whether immediate complete revascularisation is non-inferior to staged complete revascularisation during index admission in patients with STEMI and multivessel coronary artery disease.
- Conducted an open-label, multicentre, randomized non-inferiority trial across 14 hospitals in South Korea involving 994 patients (NCT04626882).
- Randomly assigned patients (1:1) after culprit-lesion percutaneous coronary intervention to immediate complete revascularisation (n=498) or staged complete revascularisation during the index admission (n=496).
- Assessed the primary composite endpoint of all-cause death, non-fatal myocardial infarction, or unplanned revascularisation at 1 year using a non-inferiority margin hazard ratio of 1.42.
- The primary composite endpoint occurred at 1 year in 65 (13%) patients in the immediate group and 53 (11%) in the staged group (HR 1.24 [95% CI 0.86–1.79]; P=0.24 for non-inferiority, margin 1.42), failing to establish non-inferiority.
- Cardiogenic shock during the index hospitalisation developed in 18 (4%) of 498 patients receiving immediate revascularisation versus 9 (2%) of 496 patients undergoing staged revascularisation.
- Complication rates for stroke, major bleeding, and contrast-induced nephropathy did not differ significantly between treatment strategies.
Study Design
Type
RCT (n=994)
Blinding
Open-label
Randomization
1:1 permuted-block
Multicenter
Yes
Structured PICO
Does immediate complete revascularisation reduce the composite of death, non-fatal myocardial infarction, or unplanned revascularisation compared to staged complete revascularisation in patients with STEMI and multivessel disease?
P
Population
994 patients aged ≥19 years with STEMI and multivessel disease who underwent PCI for a culprit lesion, followed for 1 year.
I
Intervention
Immediate complete revascularisation (percutaneous coronary intervention [PCI] for non-culprit lesions during the index procedure).
C
Comparator
Staged complete revascularisation (percutaneous coronary intervention [PCI] for non-culprit lesions on another day during the index admission).
O
Outcome
Composite of death from any cause, non-fatal myocardial infarction, or any unplanned revascularisation at 1 year.composite
Main Result
Hazard Ratio: 1.24 (95% CI 0.86–1.79)
Absolute Event Rate: 13% vs 11%
p-value: p=0.24 for noninferiority
In patients with STEMI and multivessel disease, immediate complete revascularisation during the index procedure failed to show non-inferiority to staged complete revascularisation during the index admission for 1-year clinical outcomes.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“In the OPTION-STEMI trial, immediate complete revascularization was not noninferior to staged complete revascularization during index hospitalization, meaning we do not have conclusive evidence that immediate is similar to staged complete revascularization. Two recent trials have shown that immediate complete revascularization was noninferior to staged complete revascularization. However, one trial enrolled STEMI or non-ST-elevation acute coronary syndrome patients, while the other enrolled STEMI patients at low clinical risk. In both, the staged procedure was conducted weeks after the initial procedure. Given our findings in patients with signs of heart failure, it seems prudent to limit immediate complete revascularization to stable STEMI patients with multivessel disease at low clinical risk.”
Implication
Immediate complete revascularisation failed to meet noninferiority versus staged during index admission in STEMI with multivessel disease; challenges immediate strategy and supports staging in practice.
Abstract
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.
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Cite This Study
Kim et al. (2025) conducted an RCT in ST-segment elevation myocardial infarction and multivessel disease (n=994). Immediate complete revascularisation vs. Staged complete revascularisation was evaluated on Composite of death from any cause, non-fatal myocardial infarction, or any unplanned revascularisation at 1 year (HR 1.24, 95% CI 0.86-1.79, p=0.24 for noninferiority). Immediate complete revascularisation was not noninferior to staged revascularisation for death, MI, or unplanned revascularisation at 1 year (HR 1.24; 95% CI 0.86-1.79; P=0.24 for noninferiority).