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

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

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 endpoint will be the patient-oriented composite endpoint (POCE) of all cause death, any MI, any stroke, any revascularization at one year. The key secondary endpoint 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 1400 patients. IMPLICATIONS: The FIRE trial will provide evidence on whether a specific revascularization strategy should be applied to elderly patients presenting MI and MVD in order to improve their clinical outcomes.