Journal Article

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

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

2020

Overview

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. 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. 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.

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: Acute coronary syndromes / Aged / Angiography / Cardiovascular Agents - therapeutic use / Cerebral infarction / Conservative Treatment - methods / Coronary Angiography - methods / Coronary artery / Design / Female / Functional Status / Heart attacks / Humans / Lesions / Male / Medical imaging / Mortality / Multicenter Studies as Topic / Myocardial infarction / Myocardial Revascularization - adverse effects / Myocardial Revascularization - methods / Non-ST Elevated Myocardial Infarction - mortality / Non-ST Elevated Myocardial Infarction - surgery / Older people / Patients / Performance evaluation / Physiology / Postoperative Complications - diagnosis / Postoperative Complications - etiology / Prognosis / Quality of life / Randomized Controlled Trials as Topic / Severity of Illness Index / ST Elevation Myocardial Infarction - diagnosis / ST Elevation Myocardial Infarction - mortality / ST Elevation Myocardial Infarction - surgery / Stents / Trial Design