OPTION-STEMI: Immediate versus staged complete revascularisation during index admission in patients with STEMI and multivessel disease
Reported from ESC Congress 2025
Mirvat Alasnag provides her take on OPTION-STEMI, presented by Youngkeun Ahn at ESC Congress 2025 in Madrid.
Background
The COMPLETE Trial noted that, among patients with ST elevation myocardial infarction (STEMI) and multivessel coronary artery disease, complete revascularisation was superior to culprit-lesion-only percutaneous coronary intervention (PCI) in reducing the risk of cardiovascular death or myocardial infarction, as well as the risk of cardiovascular death, myocardial infarction (MI), or ischemia-driven revascularization1.
Several studies have attempted to address the timing of the treatment of the non-infarct vessels. The CvLPRIT (Complete versus Lesion-only Primary PCI) trial is an open-label randomised study comparing complete revascularisation during the index admission with treatment of the infarct-related artery (IRA) only. It only enrolled 296 patients from the United Kingdom. Complete revascularisation was performed either at the time of the primary PCI, or before hospital discharge. Randomisation was stratified by infarct location (anterior/non-anterior) and symptom onset (≤ 3 h or > 3 h). Index admission complete revascularisation significantly lowered the rate of the composite primary endpoint of all-cause death, recurrent MI, heart failure, and ischemia-driven revascularisation at 12 months compared with treating only the IRA2.
In DANAMI-3—PRIMULTI (Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease), patients with STEMI and multivessel disease, complete revascularisation guided by fractional flow reserve (FFR) measurements significantly reduced the risk of future events compared with no further invasive intervention after primary PCI. It was driven by significantly fewer repeat revascularisations with no difference in all-cause mortality and non-fatal reinfarction3.
More recently, the BIOVASC trial concluded that immediate complete revascularisation was non-inferior to staged complete revascularisation for the primary composite outcome and was associated with a reduction in MI and unplanned ischaemia-driven revascularisation at one year. In this trial, the non-culprit lesions were treated during the index procedure or staged whereby all non-culprit lesions were treated within 6 weeks after the index procedure. This trial included those with STEMI and non-ST elevation MI4. Similarly, the MULTISTARS AMI trial, confirmed that immediate multivessel PCI was noninferior to staged multivessel PCI with respect to the risk of death from any cause, nonfatal MI, stroke, unplanned ischemia-driven revascularisation, or hospitalisation for heart failure at 1 year5.
Although all the trials to date have been consistent, the optimal timing of complete revascularisation remains debatable as the majority had the PCI as a staged procedure after hospital discharge. The OPTION-STEMI Trial addressed whether immediate complete revascularisation was non-inferior to staged complete revascularisation during the index admission.
Methods and findings
This was a non-inferiority trial conducted in South Korea. Patients aged 19 years or older with STEMI and multivessel disease who had undergone successful culprit vessel PCI were randomly assigned 1:1 to immediate complete revascularisation (during the index procedure) or staged (during the index admission).
Non-culprit lesions with 50–69 % stenosis were evaluated by FFR. Non-IRA lesions with stenosis ≥ 70 % by visual estimation did not undergo FFR assessment. Exclusion criteria included cardiogenic shock at initial presentation or after IRA treatment, unprotected LM disease with ≥ 50 % stenosis by visual estimation, chronic total non-IRA occlusion, prior coronary artery bypass grafting (CABG) or planned CABG. The primary endpoint was a composite of all-cause death, non-fatal MI, or any unplanned revascularisation at 1 year in the intention-to-treat population. The non-inferiority margin was set at a hazard ratio (HR) of 1·42.
A total of 994 patients were randomised to immediate revascularisation (n = 498) or staged revascularisation (n = 496). The median age 66 years with 79 % men. Hypertension, diabetes and dyslipidemia was noted in 40-50 % of the studied population. Anterior MI accounted for 43.2 % of those enrolled with 34.3 % in Killip class > 2. The total length of hospital stay was 3-6 days. Intravascular ultrasound was employed in approximately 23 % vs 28 %, and FFR in 42 % vs 54 %. The mean time to PCI in the staged group was 3 days. Mechanical support was required in less than 2 %.
The primary endpoint occurred at 1 year in 13.1 % of the immediate group, and 10.8 % of the staged group with non-inferiority not established (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 groups. Cardiogenic shock during the index hospitalisation was reported in 4 % of 498 patients in the immediate group, and 2 % of the staged group. The results were consistent across subgroups. Of note, there was more harm in those with signs of heart failure during the subanalysis by Killip class. Non-fatal MI occurred in 3.9 % of patients assigned to immediate revascularisation compared with 5.1 % in the staged group, while death occurred in 7.5 % vs. 5.3 % of patients, respectively.
Critical appraisal
Although the investigators are to be commended for their efforts, there were significant limitations. This was an open-label design with its inherent limitations. The non-inferiority margin was hazard ratio of 1.42, which is large, hence the results obtained.
The trial is reflective of a primarily East Asian population and cannot be generalised.
More importantly, there was a high crossover rate (10 % in the immediate group and 7 % in the staged group). In addition, there was a significant difference in the optimisation of the PCI with image guidance (intravascular ultrasound: 11 % in the immediate and 8.7 % in the staged group, & optical coherence tomography in 12.7 % of the immediate and 19.4 % of the staged group). The overall use of imaging was low considering the majority of trials in Asia have reported > 70 % use. Although FFR appeared safe with insignificant complications, the timing of the FFR varied significantly in the trial.
Finally, it is important to note that there was a higher-than-expected event rates in the immediate group and high early mortality. Those with heart failure had a signal to higher mortality with more advanced Killip class. Beyond heart failure, the complexity of the PCI and coronary anatomy and the time of the STEMI (night vs day) are important considerations as well. The completeness of revascularisation, that is the residual Syntax Score, also impacts outcomes. Such information is not readily available.
In conclusion, this trial, unfortunately, does not inform practice. The investigators did not meet the non-inferiority criteria in terms of the incidence of a composite of death from any cause, nonfatal MI, or any unplanned revascularisation at 1 year. With many unanswered questions, it remains at the discretion of the operator whether to revascularise in the same index procedure or stage during the hospitalisation.
References
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