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Randomized Controlled Trial
. 2025 Apr 14;18(7):838-848.
doi: 10.1016/j.jcin.2025.01.434.

Outcomes After CABG Compared With FFR-Guided PCI in Patients Presenting With Acute Coronary Syndrome

Affiliations
Randomized Controlled Trial

Outcomes After CABG Compared With FFR-Guided PCI in Patients Presenting With Acute Coronary Syndrome

Kuniaki Takahashi et al. JACC Cardiovasc Interv. .

Abstract

Background: There are limited data comparing coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) in patients presenting with non-ST-segment elevation acute coronary syndrome (NSTE-ACS).

Objectives: The aim of this study was to evaluate differences in outcomes in patients presenting with or without NSTE-ACS after CABG compared with fractional flow reserve (FFR)-guided PCI using current generation drug-eluting stents.

Methods: The FAME 3 trial (Fractional flow reserve versus Angiography for Multivessel Evaluation; NCT02100722) was an investigator-initiated, randomized controlled trial to attest noninferiority of FFR-guided PCI using the current-generation drug-eluting stents to CABG with respect to the primary endpoint, defined as a composite of death, myocardial infarction (MI), stroke, or repeat revascularization at 1 year, in 1,500 patients with 3-vessel coronary artery disease. The prespecified key secondary endpoint was a composite of death, MI, or stroke at 3 years.

Results: Of 1,500 patients enrolled, 587 (39.2%) presented with NSTE-ACS. Patients were followed up for a median of 1,080 days (Q1-Q3: 1,080-1,080 days). At 3 years, the risk of the composite of death, MI, or stroke was similar between patients presenting with NSTE-ACS and with chronic coronary syndrome (CCS) (11.8% vs 10.0%; adjusted HR [aHR]: 1.20; 95% CI: 0.81-1.77; P = 0.37). Patients presenting with NSTE-ACS had a similar risk of death, MI, or stroke at 3 years after CABG as compared with PCI (aHR: 0.98; 95% CI: 0.60-1.60; P = 0.94), whereas patients presenting with CCS had a significantly reduced risk after CABG compared with PCI (aHR: 0.58; 95% CI: 0.38-0.90; P = 0.02; Pinteraction = 0.11), which was driven by a lower risk of MI (aHR: 0.32; 95% CI: 0.15-0.64; P = 0.002; Pinteraction = 0.01).

Conclusions: The risk of death, MI, or stroke at 3 years was similar after CABG compared with FFR-guided PCI in patients presenting with NSTE-ACS, but reduced by CABG in patients presenting with CCS. (Fractional flow reserve versus Angiography for Multivessel Evaluation [FAME 3]; NCT02100722).

Keywords: coronary artery bypass grafting; fractional flow reserve; percutaneous coronary intervention; three-vessel coronary artery disease.

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Conflict of interest statement

Funding Support and Author Disclosures The FAME 3 trial was supported by research grants to Stanford University from Medtronic and Abbott Vascular, who were not involved in the design or conduct of the trial or in the preparation of the manuscript. Dr Piroth was supported by the STARTING 151279 grant of the Hungarian Ministry of Culture and Innovation. Dr Fearon has received institutional research grants from Abbott Vascular and Medtronic; has consulted for CathWorks; and has stock options with HeartFlow. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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