JAMA cardiology · 2025
Physiology-Guided Complete Revascularization in Older Patients With Myocardial Infarction: Three-Year Outcomes of a Randomized Clinical Trial.
Equivalence TrialСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Biscaglia Simone, Erriquez Andrea, Guiducci Vincenzo, Escaned Javier, Moreno Raul, Lanzilotti Valerio, Santarelli Andrea, Cerrato Enrico, Sacchetta Giorgio, Menozzi Alberto, Amat-Santos Ignacio, Díez Gil José Luis, Ruozzi Marco, Barbierato Marco, Fileti Luca, Picchi Andrea, Pavasini Rita, Cimaglia Paolo, Colaiori Iginio, Casella Gianni, Menozzi Mila, Cavazza Caterina, Caretta Giorgio, Scarsini Roberto, D'Amico Gianpiero, Vadalà Giuseppe, Pilato Gerlando, Moscarella Elisabetta, Tebaldi Matteo, Campo Gianluca
Аннотация
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.
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.