Physiology-Guided Complete Revascularization in Older Patients With Myocardial Infarction: Three-Year Outcomes of a Randomized Clinical Trial.

Abstract

Complete revascularization in older patients with myocardial infarction (MI) and multivessel disease has been shown to reduce cardiovascular death and MI at 1 year. However, the durability of this benefit over longer follow-up periods has been questioned by recent studies. To determine whether the benefit of physiology-guided complete treatment, compared with culprit-only treatment, is sustained at 3 years in older patients with MI and multivessel disease. This randomized clinical trial, Functional Assessment in Elderly MI Patients With Multivessel Disease (FIRE), was an investigator-initiated, multicenter, prospective, superiority trial conducted at 34 centers across 3 countries from July 18, 2019, to October 25, 2021. Participants were patients with MI (either ST segment or non-ST segment elevated) and multivessel disease who were hospitalized after successful treatment of the culprit lesion. Major exclusion criteria included a nonculprit lesion in the left main coronary artery and unclear identification of the culprit lesion. Data analysis was performed from March to May 2025. Culprit-only treatment or physiology-guided complete revascularization of nonculprit lesions. The primary outcome was a patient-oriented composite end point of death, MI, stroke, or ischemia-driven revascularization. Secondary end points included a composite of cardiovascular death or MI and rate of heart failure hospitalizations. Among 1445 patients enrolled in the trial, the median (IQR) age was 80 (77-84) years; 917 patients were male (63.5%) and 528 female (36.5%). At 3 years, the primary outcome occurred in 165 patients (22.9%) in the physiology-guided complete revascularization group and 216 patients (29.8%) in the culprit-only group (hazard ratio [HR], 0.72; 95% CI, 0.58-0.88; P = .002). The key secondary outcome of cardiovascular death or MI occurred in a significantly lower number of patients in the physiology-guided complete revascularization group (92 patients [12.8%]) compared with the culprit-only group (132 patients [18.2%]; HR, 0.66; 95% CI, 0.50-0.88; P = .004). Hospitalizations for heart failure were more frequent in the culprit-only group compared with the physiology-guided complete group (143 [19.7%] vs 103 [14.3%]; HR, 0.73; 95% CI, 0.54-0.97; P = .03). In patients 75 years or older with MI and multivessel disease, the benefit of physiology-guided complete revascularization over culprit-lesion-only treatment was sustained at 3 years. ClinicalTrials.gov Identifier: NCT03772743.