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

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.

Contrast Associated Acute Kidney Injury and Mortality in Older Adults with Acute Coronary Syndrome: A Pooled Analysis of the FRASER and HULK Studies

“…However, evidence supporting this strategy has been mainly generated in patients with STEMI and a mean age of around 60 years [ 29 ]. In older patients with multivessel disease the potential benefit of a complete or extensive revascularization should be weighed against the risk of CA-AKI [ 30 ]. Operators should consider not to overcome MACD and eventually they should pursue a reasonable or physiology-guided coronary revascularization [ 30 ].…”

“…In older patients with multivessel disease the potential benefit of a complete or extensive revascularization should be weighed against the risk of CA-AKI [ 30 ]. Operators should consider not to overcome MACD and eventually they should pursue a reasonable or physiology-guided coronary revascularization [ 30 ]. At the same time, it has to be noted that the risk profile of older MI patients with CA-AKI was significantly higher and more complex [ 26 ].…”

Quantitative Flow Ratio Is Associated with Extent and Severity of Ischemia in Non-Culprit Lesions of Patients with Myocardial Infarction

“…Here, no relevant benefit of a FFR-guided complete revascularization over angiography could be detected. Further ongoing studies, such as the FIRE trial [ 32 ], are warranted to answer this question, assessing also the role of QFR in the evaluation of non-culprit lesions in the context of myocardial infarction.…”

Functionally Complete Coronary Revascularisation in Patients Presenting with ST-elevation MI and Multivessel Coronary Artery Disease

“…In the FIRE trial, the investigators aim to provide robust evidence on whether a specific revascularisation strategy should be applied to elderly patients presenting with MI and MVD to improve their clinical outcomes. [ 43 ]…”