Physiology-guided revascularization versus optimal medical therapy of nonculprit lesions in elderly patients with myocardial infarction: Rationale and design of the FIRE trial

Simone Biscaglia, Vincenzo Guiducci, Andrea Santarelli, Ignacio Amat Santos, Francisco Fernandez-Aviles, Valerio Lanzilotti, Ferdinando Varbella, Luca Fileti, Raul Moreno, Francesco Giannini, Iginio Colaiori, Mila Menozzi, Alfredo Redondo, Marco Ruozzi, Enrique Gutiérrez Ibañes, José Luis Díez Gil, Elisa Maietti, Giuseppe Biondi Zoccai, Javier Escaned, Matteo Tebaldi, Emanuele Barbato, Dariusz Dudek, Antonio Colombo, Gianluca Campo, Simone Biscaglia, Vincenzo Guiducci, Andrea Santarelli, Ignacio Amat Santos, Francisco Fernandez-Aviles, Valerio Lanzilotti, Ferdinando Varbella, Luca Fileti, Raul Moreno, Francesco Giannini, Iginio Colaiori, Mila Menozzi, Alfredo Redondo, Marco Ruozzi, Enrique Gutiérrez Ibañes, José Luis Díez Gil, Elisa Maietti, Giuseppe Biondi Zoccai, Javier Escaned, Matteo Tebaldi, Emanuele Barbato, Dariusz Dudek, Antonio Colombo, Gianluca Campo

Abstract

Background: Myocardial infarction (MI) in elderly patients is associated with unfavorable prognosis, and it is becoming an increasingly prevalent condition. The prognosis of elderly patients is equally impaired in ST-segment elevation (STE) or non-STE (NSTE), and it is markedly worsened by the common presence of multivessel disease (MVD). Given the limited evidence available for elderly patients, it has not yet been established whether, as for younger patients, a complete revascularization strategy in MI patients with MVD should be advocated. We present the design of a dedicated study that will address this research gap.

Methods and design: The FIRE trial is a prospective, randomized, international, multicenter, open-label study with blinded adjudicated evaluation of outcomes. Patients aged 75 years and older, with MI (either STE or NSTE), MVD at coronary artery angiography, and a clear culprit lesion will be randomized to culprit-only treatment or to physiology-guided complete revascularization. The primary end point will be the patient-oriented composite end point of all-cause death, any MI, any stroke, and any revascularization at 1 year. The key secondary end point will be the composite of cardiovascular death and MI. Quality of life and physical performance will be evaluated as well. All components of the primary and key secondary outcome will be tested also at 3 and 5 years. The sample size for the study is 1,400 patients.

Implications: The FIRE trial will provide evidence on whether a specific revascularization strategy should be applied to elderly patients presenting MI and MVD to improve their clinical outcomes.

Trial registration: ClinicalTrials.gov NCT03772743.

Copyright © 2020 Elsevier Inc. All rights reserved.

Figures

Figure 1
Figure 1
Study flowchart. YS, years.

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