Noninferiority was not demonstrated between immediate and staged complete revascularisation in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease undergoing percutaneous coronary intervention (PCI), according to late-breaking research presented in a Hot Line session today at ESC Congress 20251.
Multivessel coronary artery disease - when at least two coronary arteries are blocked - affects almost half of patients who have STEMI, a type of heart attack. ESC Guidelines recommend complete revascularisation with PCI in patients with STEMI and multivessel disease, involving treating the blocked artery that caused the heart attack (culprit lesion) plus other affected vessels (non-culprit lesions).2
Explaining the aim of the OPTION-STEMI trial, its Principal Investigator, Professor Youngkeun Ahn from Chonnam National University Hospital, Gwangju, South Korea, stated, "We compared immediate complete revascularisation with PCI for the culprit and non-culprit lesions during the same procedure with staged complete revascularisation, where PCI for non-culprit lesions took place on another day during the same hospitalisation. We included a broad population of patients with STEMI and multivessel coronary artery disease."
The OPTION-STEMI trial was an investigator-initiated, open-label, noninferiority randomised trial conducted in 14 sites in South Korea. Patients were eligible if they presented with STEMI and multivessel coronary artery disease and underwent successful PCI for a culprit artery.
Patients were randomised 1:1 to either immediate complete revascularisation with simultaneous PCI for the culprit and non-culprit lesions or staged complete revascularisation that included PCI for non-culprit lesions on another day during the index hospitalisation. The primary endpoint was the composite of all-cause death, non-fatal MI and any unplanned revascularisation at 1 year.
A total of 994 patients underwent randomisation. Median age was 66 years and 79% of patients were men. One-third (33%) of patients presented with Killip class II or III, indicating signs of heart failure. The median length of hospital stay was 4 days in the immediate group and 5 days in the staged group. In the staged group, the median time to the second procedure was 3 days.
At 1 year, the primary endpoint of death, MI and any unplanned revascularisation occurred in 13.1% of patients in the immediate group and 10.8% in the staged group (hazard ratio [HR] 1.24; 95% confidence interval [CI] 0.86 to 1.79; p for noninferiority=0.24), with noninferiority not established.
Prespecified subgroup analyses suggested heterogeneity in the treatment effect according to the Killip class. Immediate complete revascularisation was associated with more harm in patients with signs of heart failure (Killip class ≥II: HR 1.79; 95% CI 1.05 to 3.05) than in patients without heart failure signs (Killip class I: HR 0.84; 95% CI 0.50 to 1.41; p for interaction=0.04).
Regarding secondary endpoints, non-fatal MI occurred in 3.9% of the patients in the immediate group and 5.1% in the staged group (HR 0.77; 95% CI 0.42 to 1.39), while death occurred in 7.5% vs. 5.3% of patients, respectively (HR 1.44; 95% CI 0.87 to 2.38).
In the OPTION-STEMI trial, immediate complete revascularisation was not noninferior to staged complete revascularisation during index hospitalisation, meaning we do not have conclusive evidence that immediate is similar to staged complete revascularisation."
Youngkeun Ahn, Study Principal Investigator and Professor, Chonnam National University Hospital
Ahn added, "Two recent trials have shown that immediate complete revascularisation was noninferior to staged complete revascularisation; 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 revascularisation to stable STEMI patients with multivessel disease at low clinical risk," Ahn concluded.
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