Noninferiority was not demonstrated in the OPTION-STEMI trial comparing immediate complete revascularization with staged complete revascularization in patients with STEMI and multivessel coronary artery disease. The findings, simultaneously published in The Lancet, were presented at ESC Congress 2025.

Trial investigators randomized a total of 994 patients at 14 sites in South Korea (median age 66 years/79% men) to either immediate complete revascularization with simultaneous PCI for the culprit and non-culprit lesions or staged complete revascularization that included PCI for non-culprit lesions on another day during the index hospitalization. All enrolled patients had presented with STEMI and multivessel coronary artery disease and underwent successful PCI for a culprit artery.

At one year, the primary endpoint of death, MI and any unplanned revascularization occurred in 13.1% of patients in the immediate revascularization group compared with 10.8% in the staged group (p for noninferiority=0.24), with noninferiority not established.

In other findings, study investigators said immediate complete revascularization was associated with more harm in patients with signs of heart failure than those without. Non-fatal MI occurred in 3.9% of patients assigned to immediate revascularization compared with 5.1% in the staged group, while death occurred in 7.5% vs. 5.3% of patients, respectively.

"Without conclusive evidence that immediate is similar to staged complete revascularization, Principal Investigator Youngkeun Ahn, MD, said it "seems prudent to limit immediate complete revascularization to stable STEMI patients with multivessel disease at low clinical risk."