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. 2025 Aug 29:e253099.
doi: 10.1001/jamacardio.2025.3099. Online ahead of print.

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

Simone Biscaglia  1 , Andrea Erriquez  1 , Vincenzo Guiducci  2 , Javier Escaned  3 , Raul Moreno  4   5 , Valerio Lanzilotti  6 , Andrea Santarelli  7 , Enrico Cerrato  8 , Giorgio Sacchetta  9 , Alberto Menozzi  10 , Ignacio Amat-Santos  11 , José Luis Díez Gil  12 , Marco Ruozzi  13 , Marco Barbierato  14 , Luca Fileti  15 , Andrea Picchi  16 , Rita Pavasini  1 , Paolo Cimaglia  1 , Iginio Colaiori  17 , Gianni Casella  6 , Mila Menozzi  18 , Caterina Cavazza  18 , Giorgio Caretta  10 , Roberto Scarsini  19 , Gianpiero D'Amico  14 , Giuseppe Vadalà  20 , Gerlando Pilato  21 , Elisabetta Moscarella  22   23 , Matteo Tebaldi  24 , Gianluca Campo  1
Affiliations

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

Simone Biscaglia et al. JAMA Cardiol. .

Abstract

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Biscaglia reported grants from Sahajanand Medical Technologies (SMT), Medis, Siemens, Insight Lifetech, GE, and Amgen during the conduct of the study and grants from Abbott outside the submitted work. Dr Erriquez reported conference fees and/or conference grants from Eukon, Medis, Philips, Abbott, and Shockwave Medical outside the submitted work. Dr Escaned reported speaker and advisory board fees from Abbott, Boston Scientific, Medis, and Philips outside the submitted work. Dr Scarsini reported personal fees from Abbott, Philips, and BBraun and grants from Abbott outside the submitted work. Dr Campo reported grants from SMT, Abbott Vascular, Siemems, and GE Healthcare during the conduct of the study. No other disclosures were reported.

References

    1. Biscaglia S, Guiducci V, Escaned J, et al. ; FIRE Trial Investigators . Complete or culprit-only PCI in older patients with myocardial infarction. N Engl J Med. 2023;389(10):889-898. doi: 10.1056/NEJMoa2300468 - DOI - PubMed
    1. Cocco M, Campo G, Guiducci V, et al. Complete vs culprit-only revascularization in older patients with myocardial infarction with or without ST-segment elevation. J Am Coll Cardiol. 2024;84(20):2014-2022. doi: 10.1016/j.jacc.2024.07.028 - DOI - PubMed
    1. Erriquez A, Campo G, Guiducci V, et al. QFR for the revascularization of nonculprit vessels in MI patients: insights from the FIRE trial. JACC Cardiovasc Interv. 2024;17(12):1425-1436. doi: 10.1016/j.jcin.2024.04.022 - DOI - PubMed
    1. Erriquez A, Campo G, Guiducci V, et al. Complete vs culprit-only revascularization in older patients with myocardial infarction and high bleeding risk: a randomized clinical trial. JAMA Cardiol. 2024;9(6):565-573. doi: 10.1001/jamacardio.2024.0804 - DOI - PMC - PubMed
    1. Mehta SR, Wood DA, Storey RF, et al. ; COMPLETE Trial Steering Committee and Investigators . Complete revascularization with multivessel PCI for myocardial infarction. N Engl J Med. 2019;381(15):1411-1421. doi: 10.1056/NEJMoa1907775 - DOI - PubMed

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