Fractional flow reserve-guided PCI compared with coronary bypass surgery - FAME - 3 (3-year follow-up Results)

Reviewer: Dr Neşet Ali Savaş

Presentation:EUROPCR 2023

Background

Previous studies have shown that CABG has better outcomes than PCI in patients with three-vessel disease. However, previous studies have used angiography-based PCI and first-generation drug-eluting stents. We know that FFR-guided PCI is better than angio-guided PCI, and that second-generation drug-eluting stents are better than bare metal stents and first-generation drug-eluting stents. Therefore, the Fame 3 study was designed to compare guided PCI with second-generation drug-eluting stents versus CABG in patients with triple-vessel disease (excluding LMCA).

Method

The primary objective of the FAME 3 Trial is to demonstrate that with 2nd generation Resolute DES, FFR-guided PCI is not inferior to CABG in patients with multivessel CAD. Study; In a multicenter, worldwide, prospective, randomized noninferiority design, 1500 patients were recruited from 50 sites and followed for up to 5 years. To the study; Patients over 21 years of age with three-vessel CAD, defined by visual estimate as ≥50% diameter stenosis in each of the three major epicardial vessels, but not including the LMCA, and eligible for revascularization by the Heart Team with both PCI and CABG were decided. To the study; Patients with a previous history of CABG, need for cardiac surgery for another reason, LMCA disease requiring revascularization, in shock or in need of mechanical/pharmacological hemodynamic support, STEMI within 5 days, or NONSTEMI and LVEF < 30% were excluded. Primary endpoints; The one-year rate of death, MI, stroke, and revascularization, secondary endpoints; Three-year follow-up for composite of death/ MI/ stroke.

Results

3-vessel patients without LMCA involvement were randomized to PCI and CABG by the cardiac team. PCI with Resolute DES Stent was applied to all lesions with FFR ≤ 0.80 in 757 patients in the PCI arm. Again based on CAG, CABG was applied to 743 patients. There was no significant difference in the predetermined composite endpoint of death, MI, and stroke with a p value of 0.07 at three years. At individual endpoints, no significant difference in composite of death, MI or stroke; stroke was the same in both groups and there was a lower rate of MI and revascularization after CABG. In subgroup analyzes, PCI was found to have a favorable outcome compared to CABG, especially in patients with a low SYNTAX score group. CABG performed better than PCI in patients with higher SYNTAX scores.

Interpretation

Limitations of the study; Intravenous imaging use was only 12% in the study and longer follow-up is needed to compare long-term results. In addition, the work was coordinated by Stanford with the support of a CRO; it has also been funded by research grants from Medtronic and St Jude Medical.