Articles
Science Matters: Research Summary of the OPTION STEMI Trial
About the Author: Michael Katsnelson MD, PhD, FACC is currently a research fellow at Washington University in St. Louis School of Medicine. He specializes in advanced heart failure/transplant cardiology and his main research interest lies in studying the role of the innate immune system in the progression of ischemic cardiomyopathy. In this article he provides a summary of a recent JACC publication.
Background: Many patients presenting with STEMI have multivessel coronary artery disease and in these patients a strategy of complete revascularization is beneficial compared to revascularization limited to the culprit lesion. However, the timing of non-culprit lesion revascularization remains an area of active research. It is unclear if the optimal management strategy is to a) address the non-culprit lesions immediately at the same time as PCI of the culprit artery is performed or b) if the non-culprit occlusive lesions should be addressed during a staged procedure in the days to weeks following the initial treatment of the culprit lesion. Several previous clinical trials have concluded that immediate complete revascularization was non-inferior to staged revascularization. Of these studies the BIOVASC clinical trial included all patients with ACS (STEMI and NSTEMI) and the MULTISTARS-AMI trial included only patients with low-risk STEMI. It is currently unclear if this previously observed non-inferiority of immediate and staged complete revascularization would be valid in a cohort of higher risk patients with STEMI including those with clinical heart failure. The OPTION-STEMI trial sought to answer the question of whether immediate complete revascularization is non-inferior to staged complete revascularization in a cohort of patients presenting with STEMI, including those patients with signs/symptoms of heart failure who were excluded from previous clinical trials.
Methods: The study was an open label, non-inferiority randomized clinical trial conducted in South Korea. Patients were eligible for the study if they presented with a STEMI, had multivessel CAD and underwent successful revascularization of the culprit artery. The main exclusion criteria included cardiogenic shock during the initial procedure or following treatment of the culprit artery, presence of unprotected left main coronary artery disease, and CTO of the non-culprit artery. The primary endpoint was a composite of death from any cause, non-fatal MI, or any unplanned coronary revascularization at 1 year following randomization. Secondary endpoints included individual components of the primary endpoint, death from cardiac cause, death from non-cardiac cause, hospitalization for heart failure, stroke, in-stent thrombosis, major bleeding and contrast induced nephropathy. The study tested the hypothesis that immediate complete revascularization is non-inferior to staged complete revascularization during the index hospital admission. A hazard ratio of 1.42 was set as the non-inferiority margin.
Results: The study included 498 patients in the immediate complete revascularization group and 496 patients in the staged complete revascularization group. Importantly, close to one third of patients in the study presented with acute heart failure in the setting of MI. At 1 year the primary endpoint occurred in 13% of patients in the immediate complete revascularization group and 11% of patients in the staged complete revascularization group. Starting at the 6-month timepoint, there were more deaths from any cause in the immediate revascularization group compared to the delayed revascularization group (HR 1.89, 95% CI 1.03-3.47). There was an increased risk of harm from immediate complete revascularization in those patients with clinical heart failure characterized by Killip class II or greater compared to those patients without evidence of heart failure. The majority of cases of cardiogenic shock and early in-stent thrombosis following revascularization of the culprit lesion occurred in patients who manifested signs/symptoms of acute heart failure on presentation.
Discussion: The authors concluded that they were unable to demonstrate noninferiority of immediate complete revascularization compared to staged complete revascularization during the index hospitalization in patients presenting with STEMI and multivessel CAD. The OPTION-PCI trial differed from previous studies because the staged revascularization procedure was performed during the index hospitalization, rather than in the outpatient setting following hospital discharge. On average, the staged revascularization of non-culprit lesions was performed within 3 days of the revascularization of the culprit artery in OPTION-STEMI vs 15 days in the BIOVASC trial and 37 days in the MULTISTARS-AMI trial. The relatively short interval between the initial revascularization of the culprit artery and subsequent revascularization of non-culprit vessels decreased the amount of time available for progression of non-culprit lesions and may have resulted in decreased incidence of death, non-fatal MI and unplanned revascularization in the staged multivessel PCI group. These results argue in favor of addressing non-culprit coronary lesions prior to hospital discharge in patients with multivessel CAD presenting with STEMI. OPTION-PCI was also unique in that one third of the study population presented with signs/symptoms of heart failure as evidenced by Killip class II or III. Subgroup analysis demonstrated that patients with Killip class II or greater had an increased likelihood of harm from immediate complete revascularization compared to Killip class I patients (HR 1.79, CI 1.05-3.05). Patients with clinical heart failure exhibited a greater likelihood of progression to cardiogenic shock or early in-stent thrombosis following immediate complete revascularization compared to patients without heart failure. These results suggest that there is an increased risk of procedural complications associated with conducting multivessel PCI in STEMI patients with impaired cardiac function.
Link to article - https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01529-6/abstract
