Highlight
– Immediate complete revascularisation during index STEMI admission was not proven non-inferior to staged revascularisation.
– At 1 year, primary composite outcomes (death, non-fatal MI, unplanned revascularisation) were similar but numerically higher in immediate group.
– Safety profiles, including stroke, bleeding, and contrast-induced nephropathy, were comparable, but cardiogenic shock was more frequent with immediate revascularisation.
– Results may influence guideline recommendations on timing of non-culprit lesion PCI in STEMI with multivessel disease.
Study Background and Disease Burden
ST-segment elevation myocardial infarction (STEMI) remains a major cause of cardiovascular morbidity and mortality worldwide. Up to 50% of STEMI patients have multivessel coronary artery disease (CAD), involving significant stenoses beyond the culprit lesion. These additional lesions confer increased risk of adverse cardiac events, yet the optimal approach to managing non-culprit lesions during primary percutaneous coronary intervention (PCI) remains debated.
Current guidelines endorse complete revascularisation in selected patients, but the timing—whether immediate during the index PCI or staged later during the index hospitalization—has been uncertain. Immediate revascularisation might reduce ischemic burden at once but carries potential procedural risks such as longer catheterisation time and contrast load. Staged procedures potentially limit risk but delay full revascularisation and might increase unplanned events.
The OPTION-STEMI trial was conceived to address this crucial clinical question by comparing immediate versus staged complete revascularisation strategies within a robust randomised design.
Study Design
OPTION-STEMI is a multicenter, open-label, randomized, non-inferiority trial conducted at 14 hospitals in South Korea involving 994 patients aged ≥19 years presenting with STEMI and multivessel disease. All participants underwent PCI of the culprit lesion. They were then allocated 1:1 by web-based permuted-block randomisation to either immediate complete revascularisation (treating non-culprit lesions with ≥70% stenosis during the same procedure) or staged complete revascularisation (non-culprit PCI performed on a different day during index admission).
Intermediate lesions with 50–69% stenosis were evaluated by fractional flow reserve to guide treatment decisions. Investigators and participants were aware of group allocation, but endpoint adjudicators were blinded.
The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction (MI), and any unplanned revascularisation at 1 year. A non-inferiority margin was defined as a hazard ratio (HR) of 1.42. Secondary outcomes included stroke, major bleeding, contrast-induced nephropathy, and cardiogenic shock during hospitalization.
Key Findings
Between December 2019 and January 2024, 994 patients were enrolled and randomly assigned to the immediate (n=498) or staged (n=496) complete revascularisation groups. Baseline characteristics were well balanced. Median follow-up was at least 1 year.
The primary composite endpoint occurred in 13% (65/498) of the immediate group versus 11% (53/496) in the staged group (HR 1.24; 95% CI 0.86–1.79; p for non-inferiority = 0.24). Since the upper bound of the 97.5% one-sided confidence interval surpassed the pre-specified non-inferiority margin of 1.42, immediate revascularisation was not statistically non-inferior to staged revascularisation.
Individual components showed no statistically significant difference: all-cause mortality and non-fatal MI rates were numerically similar across groups. Unplanned revascularisation tended to be slightly higher in the immediate group, but without statistical significance.
Adverse event rates for stroke, major bleeding, and contrast-induced nephropathy were comparable between groups. However, cardiogenic shock during index hospitalization occurred more frequently in the immediate group (4% vs 2%).
Long-term follow-up is pending to elucidate further clinical implications.
Expert Commentary
OPTION-STEMI is among the largest randomized trials comparing immediate against staged complete revascularisation in STEMI with multivessel disease, a critical clinical dilemma. The findings suggest that while immediate revascularisation is feasible and generally safe, it does not meet the criterion for non-inferiority with staged revascularisation regarding major cardiovascular events at 1 year.
The slightly elevated rate of cardiogenic shock with immediate strategy warrants cautious patient selection, especially in hemodynamically unstable individuals. The trial’s open-label design is a limitation but endpoint adjudication was blinded, enhancing validity. Fractional flow reserve guidance for intermediate lesions is a pragmatic inclusion reflecting contemporary practice.
These results align with previous studies advocating staged complete revascularisation but contrast with some reports suggesting benefits of immediate multivessel PCI. Differences may derive from patient population, procedural technique, and criteria for timing.
Clinicians should individualize revascularisation timing based on patient stability, lesion complexity, and procedural considerations. Future guideline updates may integrate OPTION-STEMI evidence to refine recommendations.
Conclusion
The OPTION-STEMI trial demonstrates that immediate complete revascularisation during the index admission for STEMI patients with multivessel disease is not non-inferior to staged revascularisation with respect to 1-year composite outcomes. The modestly increased cardiogenic shock risk with the immediate approach emphasizes tailored clinical judgment over routine one-stage complete PCI. Ongoing long-term data and further trials may clarify optimal strategies to improve survival and reduce recurrent ischemic events in this high-risk population.
References
Kim MC, Ahn JH, Hyun DY, et al; OPTION-STEMI Investigators. 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. Lancet. 2025 Sep 6;406(10507):1032-1043. doi: 10.1016/S0140-6736(25)01529-6. PMID: 40902612.
Windecker S, Kolh P, Alfonso F, et al. 2014 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2014;35(37):2541-2619.
Bainey KR, Mehta SR, Yuan Z, et al. Multivessel versus culprit-only stenting in patients with acute myocardial infarction and multivessel coronary artery disease: a systematic review and meta-analysis. J Am Coll Cardiol. 2020;75(16):2020-2032.
