Fractional flow reserve versus angiography-guided strategy in acute myocardial infarction with multivessel disease: a randomized trial

Abstract

Aims In patients with acute myocardial infarction (MI) and multivessel coronary artery disease, percutaneous coronary intervention (PCI) of non-infarct-related artery reduces death or MI. However, whether selective PCI guided by fractional flow reserve (FFR) is superior to routine PCI guided by angiography alone is unclear. The current trial sought to compare FFR-guided PCI with angiography-guided PCI for non-infarct-related artery lesions among patients with acute MI and multivessel disease. Methods and results Patients with acute MI and multivessel coronary artery disease who had undergone successful PCI of the infarct-related artery were randomly assigned to either FFR-guided PCI (FFR ≤0.80) or angiography-guided PCI (diameter stenosis of >50%) for non-infarct-related artery lesions. The primary end point was a composite of time to death, MI, or repeat revascularization. A total of 562 patients underwent randomization. Among them, 60.0% underwent immediate PCI for non-infarct-related artery lesions and 40.0% were treated by a staged procedure during the same hospitalization. PCI was performed for non-infarct-related artery in 64.1% in the FFR-guided PCI group and 97.1% in the angiography-guided PCI group, and resulted in significantly fewer stent used in the FFR-guided PCI group (2.2 ± 1.1 vs. 2.5 ± 0.9, P < 0.001). At a median follow-up of 3.5 years (interquartile range: 2.7–4.1 years), the primary end point occurred in 18 patients of 284 patients in the FFR-guided PCI group and in 40 of 278 patients in the angiography-guided PCI group (7.4% vs. 19.7%; hazard ratio, 0.43; 95% confidence interval, 0.25–0.75; P = 0.003). The death occurred in five patients (2.1%) in the FFR-guided PCI group and in 16 patients (8.5%) in the angiography-guided PCI group; MI in seven (2.5%) and 21 (8.9%), respectively; and unplanned revascularization in 10 (4.3%) and 16 (9.0%), respectively. Conclusion In patients with acute MI and multivessel coronary artery disease, a strategy of selective PCI using FFR-guided decision-making was superior to a strategy of routine PCI based on angiographic diameter stenosis for treatment of non-infarct-related artery lesions regarding the risk of death, MI, or repeat revascularization.

Angiographic Severity of the Nonculprit Lesion and the Efficacy of Fractional Flow Reserve–Guided Complete Revascularization in Patients With AMI: FRAME-AMI Substudy

“…FRAME-AMI and FLOWER-MI (Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction) trials comparing angiography-guided PCI to FFR-guided PCI for patients with AMI and multivessel illness have shown inconsistent results. 9,21 Both trials defined eligible non-IRA lesions as 50% or more in diameter by visual assessment. The FLOWER-MI trial, which included 1171 STEMI patients with multivessel disease, found no statistically significant difference between the 2 strategies at 1 year.…”

Management of Non-Culprit Lesions in STEMI Patients with Multivessel Disease

“…The risk of the primary endpoint, a composite of time to death, MI, or repeat revascularization, was significantly reduced in the FFR-guided PCI group vs. the angiography-guided PCI group (7.4% vs. 19.7%; HR: 0.43; 95% CI: 0.25–0.75; p = 0.003) at the 3.5-year follow-up. The benefit of FFR-guided PCI on the primary endpoint was consistent regardless of STEMI or non-STEMI patients [ 33 ].…”

“…CS is a high-acuity, complex, and hemodynamically diverse state of end-organ hypoperfusion that is frequently associated with multivessel disease, which is more frequently followed by a worse outcome and mortality than single-vessel disease. The current American College of Cardiology/American Heart Association (ACC/AHA) and ESC guidelines do not recommend PCI of non-IRA at the time of primary PCI during acute myocardial infarction in patients with CS (class III, level of evidence B) because of the higher risk of death or renal failure [ 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 ]. Risks associated with CR include volume overload, contrast renal injury, more prolonged procedure times, and ischemic complications in the non-culprit vessel, resulting in further hemodynamic deterioration.…”

More Attention Should Be Paid to Less Severe Nonculprit Lesions

“…Two randomized trials directly comparing these approaches have shown mixed results. 5,6 The COMPLETE-2 trial will address this question in a 5100 patient multinational trial where patients with acute coronary syndrome (ST-segment elevation myocardial infarction [STEMI] or non-STEMI) and multivessel coronary artery disease are randomized to receive complete revascularization with PCI using either an angiographyguided or a physiology-guided strategy. The trial will also have a large-scale optical coherence tomography substudy designed to determine whether vulnerable plaque morphology (TCFA) predicts future cardiovascular events.…”