作者
Simone Biscaglia,Andrea Erriquez,Vincenzo Guiducci,Javier Escaned,Raúl Moreno,Valerio Lanzilotti,Andrea Santarelli,Enrico Cerrato,Giorgio Sacchetta,Alberto Menozzi,Ignacio J. Amat‐Santos,José Luis Díez Gil,Marco Ruozzi,Marco Barbierato,Luca Fileti,Andrea Picchi,Rita Pavasini,Paolo Cimaglia,Iginio Colaiori,Gianni Casella
摘要
Importance 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. Objective 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. Design, Setting, and Participants 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. Interventions Culprit-only treatment or physiology-guided complete revascularization of nonculprit lesions. Main Outcomes and Measures 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. Results 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). Conclusions and Relevance 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. Trial Registration ClinicalTrials.gov Identifier: NCT03772743